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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01541215
Registration number
NCT01541215
Ethics application status
Date submitted
23/02/2012
Date registered
29/02/2012
Titles & IDs
Public title
Efficacy and Safety of Liraglutide in Combination With Metformin Compared to Metformin Alone, in Children and Adolescents With Type 2 Diabetes
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Scientific title
Efficacy and Safety of Liraglutide in Combination With Metformin Versus Metformin Monotherapy on Glycaemic Control in Children and Adolescents With Type 2 Diabetes
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Secondary ID [1]
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2011-002605-29
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Secondary ID [2]
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NN2211-3659
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Universal Trial Number (UTN)
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Trial acronym
Ellipse™
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Diabetes
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Diabetes Mellitus, Type 2
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Condition category
Condition code
Metabolic and Endocrine
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Diabetes
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - liraglutide
Treatment: Drugs - placebo
Treatment: Drugs - metformin
Experimental: Lira + Met -
Placebo comparator: Placebo + Met -
Treatment: Drugs: liraglutide
Administered subcutaneously (s.c., under the skin) once daily.1.8 mg or maximum tolerated dose (MTD: 0.6 mg, 1.2 mg, 1.8 mg) for 26 weeks. Subjects will continue treatment in a 26 week open-labelled extension. Rescue treatment will be allowed if rescue criteria are met.
Treatment: Drugs: placebo
Administered subcutaneously (s.c., under the skin) once daily for 26 weeks. Subjects will discontinue placebo treatment in the open-labelled extension. Rescue treatment will be allowed if rescue criteria are met.
Treatment: Drugs: metformin
Tablets administered for 26 weeks. Maximum tolerated dose (MTD) between 1000-2000 mg at the discretion of the investigator. Subjects will continue treatment in a 26 week open-labelled extension.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change in HbA1c (Glycosylated Haemoglobin)
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Assessment method [1]
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Change in HbA1c from baseline to week 26. All available data were used for the primary analysis, including data collected after treatment discontinuation and initiation of rescue medication.
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Timepoint [1]
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Week 0, week 26
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Secondary outcome [1]
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Change From Baseline in Fasting Plasma Glucose (FPG)
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Assessment method [1]
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Change in FPG from baseline to week 26. All available data were used for the analysis, including data collected after treatment discontinuation and initiation of rescue medication.
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Timepoint [1]
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Week 0, week 26
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Secondary outcome [2]
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Number of Subjects Having HbA1c Below 7.0%
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Assessment method [2]
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Percentage of subjects having HbA1c \<7.0%. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
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Timepoint [2]
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Week 26
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Secondary outcome [3]
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Change From Baseline in Body Mass Index (BMI) Standard Deviation Score (SDS)
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Assessment method [3]
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Change in BMI SDS from baseline to week 26. BMI SDS was calculated using the following formula: Z=\[(value /M)\^L - 1\] / S\*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' BMI provided for each sex and age. For each subject, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. The method is described in the world health organisation (WHO) Multicentre Growth Reference, which also contains the values for L, M and S by age and sex. For Z (SDS) scores below -3 and above 3, the score was adjusted as described in the WHO instruction. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
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Timepoint [3]
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Week 0, week 26
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Secondary outcome [4]
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Number of Subjects Having HbA1c Below 7.0%
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Assessment method [4]
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Number of subjects achieving HbA1c \<7.0% after 52 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
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Timepoint [4]
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Week 52
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Secondary outcome [5]
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Number of Subjects Having HbA1c Maximum 6.5%
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Assessment method [5]
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Number of subjects achieving HbA1c \<=6.5% after 26 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
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Timepoint [5]
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Week 26
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Secondary outcome [6]
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Number of Subjects Having HbA1c Maximum 6.5%
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Assessment method [6]
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Number of subjects achieving HbA1c \<=6.5% after 52 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
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Timepoint [6]
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Week 52
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Secondary outcome [7]
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Number of Subjects Having HbA1c Below 7.0% Without Severe or Minor Hypoglycaemic Episodes
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Assessment method [7]
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Number of subjects achieving HbA1c \<7.0% without severe or minor hypoglycaemic episodes after 26 weeks.
Severe hypoglycaemia: An episode requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions.
Minor hypoglycaemia was defined as meeting either of the below criteria:
1. an episode with symptoms consistent with hypoglycaemia with confirmation by blood glucose \<2.8 mmol/L (50 mg/dL) or plasma glucose \<3.1 mmol/L (56 mg/dL), and which was handled by the subject him/herself
2. any asymptomatic blood glucose value \<2.8 mmol/L (50 mg/dL) or plasma glucose value \<3.1 mmol/L (56 mg/dL) All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
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Timepoint [7]
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Week 26
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Secondary outcome [8]
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Number of Subjects Having HbA1c Below 7.0% Without Severe or Minor Hypoglycaemic Episodes
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Assessment method [8]
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Number of subjects achieving HbA1c \<7.0% without severe or minor hypoglycaemic episodes after 52 weeks.
Severe hypoglycaemia: An episode requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions.
Minor hypoglycaemia was defined as meeting either of the below criteria:
1. an episode with symptoms consistent with hypoglycaemia with confirmation by blood glucose \<2.8 mmol/L (50 mg/dL) or plasma glucose \<3.1 mmol/L (56 mg/dL), and which was handled by the subject him/herself
2. any asymptomatic blood glucose value \<2.8 mmol/L (50 mg/dL) or plasma glucose value \<3.1 mmol/L (56 mg/dL) All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
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Timepoint [8]
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Week 52
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Secondary outcome [9]
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Number of Subjects Having HbA1c Below 7.5%
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Assessment method [9]
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Number of subjects achieving HbA1c \<7.5% after 26 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
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Timepoint [9]
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Week 26
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Secondary outcome [10]
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Number of Subjects Having HbA1c Below 7.5%
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Assessment method [10]
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Number of subjects achieving HbA1c \<7.5% after 52 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
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Timepoint [10]
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Week 52
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Secondary outcome [11]
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Change in HbA1c
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Assessment method [11]
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Change in HbA1c from baseline to week 52. All available data were used for the analysis, including data collected after treatment discontinuation and initiation of rescue medication.
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Timepoint [11]
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Week 0, week 52
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Secondary outcome [12]
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Change in FPG
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Assessment method [12]
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Change in FPG from baseline to week 52. All available data were used for the analysis, including data collected after treatment discontinuation and initiation of rescue medication.
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Timepoint [12]
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Week 0, week 52
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Secondary outcome [13]
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Change in Mean 7-point Self-measured Plasma Glucose
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Assessment method [13]
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Change in mean 7-point self-measured plasma glucose after 26 weeks. Subjects were instructed to measure their plasma glucose at following timepoints: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner and at bedtime. Mean 7-point SMPG was defined as the area under the profile (calculated using the trapezoidal method) divided by time. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
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Timepoint [13]
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Week 0, week 26
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Secondary outcome [14]
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Change From Baseline in 7-point Self-measured Plasma Glucose
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Assessment method [14]
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Change in mean 7-point self-measured plasma glucose after 52 weeks. Subjects were instructed to measure their plasma glucose at following timepoints: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner and at bedtime. Mean 7-point SMPG was defined as the area under the profile (calculated using the trapezoidal method) divided by time. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
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Timepoint [14]
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Week 0, week 52
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Secondary outcome [15]
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Change in Post-prandial Increments (From Before Meal to 90 Min After Breakfast, Lunch, and Dinner)
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Assessment method [15]
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Change in post-prandial increments (from before meal to 90 min after breakfast, lunch, and dinner) after 26 weeks. Post-prandial increment for each meal (breakfast, lunch, and dinner) was derived from the 7-point SMPG profile as the difference between post-prandial plasma glucose values and the plasma glucose values before the meal. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
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Timepoint [15]
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Week 0, week 26
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Secondary outcome [16]
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Change in Post-prandial Increments (From Before Meal to 90 Min After Breakfast, Lunch, and Dinner)
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Assessment method [16]
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Change in post-prandial increments (from before meal to 90 min after breakfast, lunch, and dinner) after 52 weeks. Post-prandial increment for each meal (breakfast, lunch, and dinner) was derived from the 7-point SMPG profile as the difference between post-prandial plasma glucose values and the plasma glucose values before the meal. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
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Timepoint [16]
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Week 0, week 52
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Secondary outcome [17]
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Change in Mean Post-prandial Increment Across All Three Meals (Breakfast, Lunch, and Dinner)
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Assessment method [17]
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Change in mean post-prandial increment across all three meals (breakfast, lunch, and dinner) after 26 weeks. Post-prandial increment for each meal (breakfast, lunch, and dinner) was derived from the 7-point SMPG profile as the difference between post-prandial plasma glucose values and the plasma glucose values before the meal. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
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Timepoint [17]
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0
Week 0, week 26
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Secondary outcome [18]
0
0
Change in Mean Post-prandial Increment Across All Three Meals (Breakfast, Lunch, and Dinner)
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Assessment method [18]
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Change in mean post-prandial increment across all three meals (breakfast, lunch, and dinner) after 52 weeks. Post-prandial increment for each meal (breakfast, lunch, and dinner) was derived from the 7-point SMPG profile as the difference between post-prandial plasma glucose values and the plasma glucose values before the meal. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
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Timepoint [18]
0
0
Week 0, week 52
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Secondary outcome [19]
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Change From Baseline in Body Weight
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Assessment method [19]
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Change from baseline in body weight after 26 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
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Timepoint [19]
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Week 0, week 26
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Secondary outcome [20]
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Change From Baseline in Body Weight
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Assessment method [20]
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Change from baseline in body weight after 52 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
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Timepoint [20]
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0
Week 0, week 52
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Secondary outcome [21]
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Change From Baseline in BMI Standard Deviation Score (SDS)
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Assessment method [21]
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Change in BMI SDS from baseline to week 52. BMI SDS was calculated using the following formula: Z=\[(value /M)\^L - 1\] / S\*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' BMI provided for each sex and age. For each subject, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. The method is described in the WHO Multicentre Growth Reference, which also contains the values for L, M and S by age and sex. For Z (SDS) scores below -3 and above 3, the score was adjusted as described in the WHO instruction. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
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Timepoint [21]
0
0
Week 0, week 52
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Secondary outcome [22]
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Change in Blood Pressure (Systolic and Diastolic Blood Pressure)
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Assessment method [22]
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Change in blood pressure (systolic and diastolic blood pressure) after 26 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
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Timepoint [22]
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Week 0, week 26
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Secondary outcome [23]
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Change in Blood Pressure (Systolic and Diastolic Blood Pressure)
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Assessment method [23]
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Change in blood pressure (systolic and diastolic blood pressure) after 52 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
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Timepoint [23]
0
0
Week 0, week 52
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Secondary outcome [24]
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Ratio to Baseline: Fasting Insulin
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Assessment method [24]
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Ratio to baseline (fasting insulin) at week 26. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
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Timepoint [24]
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0
Week 0, week 26
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Secondary outcome [25]
0
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Ratio to Baseline: Fasting Insulin
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Assessment method [25]
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Ratio to baseline (fasting insulin) at week 52. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
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Timepoint [25]
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Week 0, week 52
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Secondary outcome [26]
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Ratio to Baseline: Fasting Pro-insulin
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Assessment method [26]
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Ratio to baseline (fasting pro-insulin) at week 26. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
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Timepoint [26]
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Week 0, week 26
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Secondary outcome [27]
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Ratio to Baseline: Fasting Pro-insulin
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Assessment method [27]
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Ratio to baseline (fasting pro-insulin) at week 52. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
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Timepoint [27]
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Week 0, week 52
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Secondary outcome [28]
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Ratio to Baseline: Pro-insulin/Insulin Ratio
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Assessment method [28]
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Ratio to baseline (Pro-insulin/insulin ratio) after week 26. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
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Timepoint [28]
0
0
Week 0, week 26
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Secondary outcome [29]
0
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Ratio to Baseline: Pro-insulin/Insulin Ratio
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Assessment method [29]
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Ratio to baseline (Pro-insulin/insulin ratio) after week 52. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
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Timepoint [29]
0
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Week 0, week 52
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Secondary outcome [30]
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Ratio to Baseline: Fasting Glucagon
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Assessment method [30]
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Ratio to baseline (fasting glucagon) at week 26. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
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Timepoint [30]
0
0
Week 0, week 26
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Secondary outcome [31]
0
0
Ratio to Baseline: Fasting Glucagon
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Assessment method [31]
0
0
Ratio to baseline (fasting glucagon) at week 52. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
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Timepoint [31]
0
0
Week 0, week 52
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Secondary outcome [32]
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Ratio to Baseline: Fasting C-peptide
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Assessment method [32]
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Ratio to baseline (fasting C-peptide) at week 26. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
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Timepoint [32]
0
0
Week 0, week 26
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Secondary outcome [33]
0
0
Ratio to Baseline: Fasting C-peptide
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Assessment method [33]
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Ratio to baseline (fasting C-peptide) at week 52. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
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Timepoint [33]
0
0
Week 0, week 52
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Secondary outcome [34]
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0
Ratio to Baseline: Homeostasis Model Assessment of Beta-cell Function (HOMA-B)
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Assessment method [34]
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Ratio to baseline (HOMA-B) after 26 weeks. HOMA-B is an index of beta-cell function and was calculated from fasting insulin. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
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Timepoint [34]
0
0
Week 0, week 26
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Secondary outcome [35]
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0
Ratio to Baseline: HOMA-B
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Assessment method [35]
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Ratio to baseline (HOMA-B) after 52 weeks. HOMA-B is an index of beta-cell function and was calculated from fasting insulin. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
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Timepoint [35]
0
0
Week 0, week 52
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Secondary outcome [36]
0
0
Ratio to Baseline: Homeostasis Model Assessment as an Index of Insulin Resistance (HOMA-IR)
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Assessment method [36]
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Ratio to baseline (HOMA-IR) after 26 weeks. HOMA-IR is an index of insulin resistance and was calculated from fasting insulin. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
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Timepoint [36]
0
0
Week 0, week 26
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Secondary outcome [37]
0
0
Ratio to Baseline: HOMA-IR
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Assessment method [37]
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0
Ratio to baseline (HOMA-IR) after 52 weeks. HOMA-IR is an index of insulin resistance and was calculated from fasting insulin. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
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Timepoint [37]
0
0
Week 0, week 52
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Secondary outcome [38]
0
0
Ratio to Baseline: Total Cholesterol
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Assessment method [38]
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0
Ratio to baseline (total cholesterol) after 26 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
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Timepoint [38]
0
0
Week 0, week 26
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Secondary outcome [39]
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0
Ratio to Baseline: Total Cholesterol
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Assessment method [39]
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0
Ratio to baseline (total cholesterol) after 52 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
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Timepoint [39]
0
0
Week 0, week 52
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Secondary outcome [40]
0
0
Ratio to Baseline: Low Density Lipoprotein (LDL) Cholesterol
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Assessment method [40]
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Ratio to baseline (LDL cholesterol) after 26 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
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Timepoint [40]
0
0
Week 0, week 26
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Secondary outcome [41]
0
0
Ratio to Baseline: LDL Cholesterol
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Assessment method [41]
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0
Ratio to baseline (LDL cholesterol) after 52 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
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Timepoint [41]
0
0
Week 0, week 52
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Secondary outcome [42]
0
0
Ratio to Baseline: Very Low-density Lipoprotein (VLDL) Cholesterol
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Assessment method [42]
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0
Ratio to baseline (VLDL cholesterol) after 26 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
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Timepoint [42]
0
0
Week 0, week 26
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Secondary outcome [43]
0
0
Ratio to Baseline: VLDL Cholesterol
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Assessment method [43]
0
0
Ratio to baseline (VLDL cholesterol) after 52 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
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Timepoint [43]
0
0
Week 0, week 52
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Secondary outcome [44]
0
0
Ratio to Baseline: High-density Lipoprotein (HDL) Cholesterol
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Assessment method [44]
0
0
Ratio to baseline (HDL cholesterol) after 26 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
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Timepoint [44]
0
0
Week 0, week 26
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Secondary outcome [45]
0
0
Ratio to Baseline: HDL Cholesterol
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Assessment method [45]
0
0
Ratio to baseline (HDL cholesterol) after 52 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
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Timepoint [45]
0
0
Week 0, week 52
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Secondary outcome [46]
0
0
Ratio to Baseline: Triglycerides
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Assessment method [46]
0
0
Ratio to baseline (triglycerides) after 26 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
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Timepoint [46]
0
0
Week 0, week 26
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Secondary outcome [47]
0
0
Ratio to Baseline: Triglycerides
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Assessment method [47]
0
0
Ratio to baseline (triglycerides) after 52 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
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Timepoint [47]
0
0
Week 0, week 52
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Secondary outcome [48]
0
0
Ratio to Baseline: Free Fatty Acids
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Assessment method [48]
0
0
Ratio to baseline (free fatty acids) after 26 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
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Timepoint [48]
0
0
Week 0, week 26
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Secondary outcome [49]
0
0
Ratio to Baseline: Free Fatty Acids
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Assessment method [49]
0
0
Ratio to baseline (free fatty acids) after 52 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
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Timepoint [49]
0
0
Week 0, week 52
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Secondary outcome [50]
0
0
Change From Baseline in Pulse
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Assessment method [50]
0
0
Change from baseline in pulse 26 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
Query!
Timepoint [50]
0
0
Week 0, week 26
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Secondary outcome [51]
0
0
Change From Baseline in Pulse
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Assessment method [51]
0
0
Change from baseline in pulse 52 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
Query!
Timepoint [51]
0
0
Week 0, week 52
Query!
Secondary outcome [52]
0
0
Change From Baseline in Height SDS
Query!
Assessment method [52]
0
0
Change in height SDS from baseline to week 26. Height SDS was calculated using the following formula: Z=\[(value /M)\^L - 1\] / S\*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' height provided for each sex and age. For each subject, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. The method is described in the WHO Multicentre Growth Reference, which also contains the values for L, M and S by age and sex. For Z (SDS) scores below -3 and above 3, the score was adjusted as described in the WHO instruction. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
Query!
Timepoint [52]
0
0
Week 0, week 26
Query!
Secondary outcome [53]
0
0
Change From Baseline in Height SDS
Query!
Assessment method [53]
0
0
Change in height SDS from baseline to week 52. Height SDS was calculated using the following formula: Z=\[(value /M)\^L - 1\] / S\*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' height provided for each sex and age. For each subject, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. The method is described in the WHO Multicentre Growth Reference, which also contains the values for L, M and S by age and sex. For Z (SDS) scores below -3 and above 3, the score was adjusted as described in the WHO instruction. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
Query!
Timepoint [53]
0
0
Week 0, week 52
Query!
Secondary outcome [54]
0
0
Change in Bone Age Assessment (X-ray of Left Hand and Wrist)
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Assessment method [54]
0
0
Change in bone age from baseline to week 52. If the baseline (week 0) bone age assessment indicated that all epiphyses were fused, then the assessment was not repeated at week 52.
Query!
Timepoint [54]
0
0
Week 0, week 52
Query!
Secondary outcome [55]
0
0
Pubertal Assessment/Progression (Tanner Staging)
Query!
Assessment method [55]
0
0
Pubertal development was assessed in 3 areas (breast, penis and pubic hair development) by the Tanner staging in accordance with stages I-V. The Tanner staging assessment was no longer required to be performed once a subject reached the Tanner stage V, as judged by the investigator. Reported results are number of participants at different Tanner stages at week 0, week 26 and week 52.
Query!
Timepoint [55]
0
0
Week 0, week 26, week 52
Query!
Secondary outcome [56]
0
0
Growth (Height Velocity)
Query!
Assessment method [56]
0
0
Growth (i.e., height velocity) is the change in height per year and is measured in cm/year. The height velocity was calculated as the difference between current height and height at baseline (week 0) divided by the time (in days) between those measurement time points and multiplied by 365 days.
Query!
Timepoint [56]
0
0
Week 0, week 26
Query!
Secondary outcome [57]
0
0
Growth (Height Velocity)
Query!
Assessment method [57]
0
0
Growth (i.e., height velocity) is the change in height per year and is measured in cm/year. The height velocity was calculated as the difference between current height and height at baseline (week 0) divided by the time (in days) between those measurement time points and multiplied by 365 days.
Query!
Timepoint [57]
0
0
Week 0, week 52
Query!
Secondary outcome [58]
0
0
Height Velocity SDS
Query!
Assessment method [58]
0
0
Height velocity SDS scores at week 26. Height velocity is change in height per year. The height velocity was calculated as the difference between current height and height at baseline (week 0) divided by time between those measurement time points and multiplied by 365 days. Height velocity SDS was calculated using following formula: Z=\[(value /M)\^L - 1\] / S\*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' height provided for each sex and age. For each subject, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. The method is described in the WHO Multicentre Growth Reference, which also contains the values for L, M and S by age and sex. For Z (SDS) scores below -3 and above 3, the score was adjusted as described in the WHO instruction. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
Query!
Timepoint [58]
0
0
Week 0, week 26
Query!
Secondary outcome [59]
0
0
Height Velocity SDS
Query!
Assessment method [59]
0
0
Height velocity SDS scores at week 52. Height velocity is change in height per year. The height velocity was calculated as the difference between current height and height at baseline (week 0) divided by time between those measurement time points and multiplied by 365 days. Height velocity SDS was calculated using following formula: Z=\[(value /M)\^L - 1\] / S\*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' height provided for each sex and age. For each subject, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. The method is described in the WHO Multicentre Growth Reference, which also contains the values for L, M and S by age and sex. For Z (SDS) scores below -3 and above 3, the score was adjusted as described in the WHO instruction. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
Query!
Timepoint [59]
0
0
Week 0, week 52
Query!
Secondary outcome [60]
0
0
Number of Hypoglycaemic Episodes
Query!
Assessment method [60]
0
0
Total number of hypoglycaemic episodes according to American Diabetes Association (ADA) classification from baseline (week 0) to week 26.
Query!
Timepoint [60]
0
0
0-26 weeks
Query!
Secondary outcome [61]
0
0
Number of Hypoglycaemic Episodes
Query!
Assessment method [61]
0
0
Total number of hypoglycaemic episodes according to American Diabetes Association (ADA) classification from baseline (week 0) to week 52.
Query!
Timepoint [61]
0
0
0-52 weeks
Query!
Secondary outcome [62]
0
0
Number of Adverse Events (Week 0-26)
Query!
Assessment method [62]
0
0
Total number of adverse events during 26 weeks.
Query!
Timepoint [62]
0
0
0-26 weeks
Query!
Secondary outcome [63]
0
0
Number of Adverse Events (Week 0-52)
Query!
Assessment method [63]
0
0
Total number of adverse events during entire treatment period.
Query!
Timepoint [63]
0
0
0-52 weeks
Query!
Secondary outcome [64]
0
0
Number of Serious Adverse Events (Week 0-26)
Query!
Assessment method [64]
0
0
Total number of serious adverse events during 26 weeks.
Query!
Timepoint [64]
0
0
0-26 weeks
Query!
Secondary outcome [65]
0
0
Number of Serious Adverse Events (Week 0-52)
Query!
Assessment method [65]
0
0
Total number of serious adverse events during entire treatment period.
Query!
Timepoint [65]
0
0
0-52 weeks
Query!
Secondary outcome [66]
0
0
Number of Adverse Events (Week 53-104)
Query!
Assessment method [66]
0
0
This outcome is applicable only for the Liraglutide 1.8 mg treatment arm. Number of adverse events reported during follow-up 1 (week 53 to 104).
Query!
Timepoint [66]
0
0
Week 53-104
Query!
Secondary outcome [67]
0
0
Number of Serious Adverse Events (Week 53-104)
Query!
Assessment method [67]
0
0
This outcome is applicable only for the Liraglutide 1.8 mg treatment arm. Number of serious adverse events reported during follow up 1 (week 53 to 104).
Query!
Timepoint [67]
0
0
Weeks 53-104
Query!
Secondary outcome [68]
0
0
Growth (Height Velocity)- Week 104
Query!
Assessment method [68]
0
0
Growth (i.e., height velocity) is the change in height per year and is measured in cm/year. The height velocity was calculated as the difference between current height and height at baseline (week 0) divided by the time (in days) between those measurement time points and multiplied by 365 days. This outcome is applicable only for the Liraglutide 1.8 mg treatment arm.
Query!
Timepoint [68]
0
0
Week 0, week 104
Query!
Secondary outcome [69]
0
0
Height Velocity SDS- Week 104
Query!
Assessment method [69]
0
0
The height velocity was calculated as the difference between current height and height at baseline (week 0) divided by time between those measurement time points and multiplied by 365 days. Height velocity SDS was calculated using following formula: Z=\[(value /M)\^L - 1\] / S\*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' height provided for each sex and age. For each subject, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. The method is described in the WHO Multicentre Growth Reference, which also contains the values for L, M and S by age and sex. For Z (SDS) scores below -3 and above 3, the score was adjusted as described in the WHO instruction. This outcome is applicable only for the Liraglutide 1.8 mg treatment arm.
Query!
Timepoint [69]
0
0
Week 0, week 104
Query!
Secondary outcome [70]
0
0
Change From Week 52 in Height SDS- Week 104
Query!
Assessment method [70]
0
0
Change in height SDS from week 52 to week 104. Height SDS was calculated using the following formula: Z=\[(value /M)\^L - 1\] / S\*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' height provided for each sex and age. For each subject, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. The method is described in the WHO Multicentre Growth Reference, which also contains the values for L, M and S by age and sex. For Z (SDS) scores below -3 and above 3, the score was adjusted as described in the WHO instruction. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. This outcome is applicable only for the Liraglutide 1.8 mg treatment arm.
Query!
Timepoint [70]
0
0
Week 52, week 104
Query!
Secondary outcome [71]
0
0
Change in Pubertal Assessment/Progression (Tanner Staging)- Week 104
Query!
Assessment method [71]
0
0
Pubertal development was assessed in 3 areas (breast, penis and pubic hair development) by the Tanner staging in accordance with stages I-V, where stage I represents "pre-adoloscent development" and stage V represents "pubertal development equivalent to that of an adult". The Tanner staging assessment was no longer required to be performed once a subject reached the Tanner stage V, as judged by the investigator. Reported results are number of subjects at different Tanner stages at week 52 and week 104. This outcome is applicable only for the Liraglutide 1.8 mg treatment arm.
Query!
Timepoint [71]
0
0
Week 52, week 104
Query!
Secondary outcome [72]
0
0
Change From Week 52 in Bone Age Assessment (X-ray of Left Hand and Wrist)- Week 104
Query!
Assessment method [72]
0
0
Change in bone age from week 52 to week 104. This outcome is applicable only for the Liraglutide 1.8 mg treatment arm.
Query!
Timepoint [72]
0
0
Week 52, week 104
Query!
Secondary outcome [73]
0
0
Number of Adverse Events (Week 53-156)
Query!
Assessment method [73]
0
0
This outcome measure is applicable only for the Liraglutide 1.8 mg treatment arm. Number of adverse events reported during the follow-up period (weeks 53 to 156).
Query!
Timepoint [73]
0
0
Week 53-156
Query!
Secondary outcome [74]
0
0
Number of Serious Adverse Events (Week 53-156)
Query!
Assessment method [74]
0
0
This outcome measure is applicable only for the Liraglutide 1.8 mg treatment arm. Number of serious adverse events reported during the follow up period (week 53 to 156).
Query!
Timepoint [74]
0
0
Weeks 53-156
Query!
Secondary outcome [75]
0
0
Growth (Height Velocity)- Week 156
Query!
Assessment method [75]
0
0
Growth (i.e., height velocity) is the change in height per year and is measured in cm/year. The height velocity was calculated as the difference between current height and height at baseline (week 0) divided by the time (in days) between those measurement time points and multiplied by 365 days. This outcome measure is applicable only for the Liraglutide 1.8 mg treatment arm.
Query!
Timepoint [75]
0
0
Week 0, week 156
Query!
Secondary outcome [76]
0
0
Height Velocity SDS- Week 156
Query!
Assessment method [76]
0
0
The height velocity was calculated as the difference between current height and height at baseline (week 0) divided by time between those measurement time points and multiplied by 365 days. Height velocity SDS was calculated using following formula: Z=\[(value /M)\^L - 1\] / S\*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' height provided for each sex and age. For each subject, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. The method is described in the WHO Multicentre Growth Reference, which also contains the values for L, M and S by age and sex. For Z (SDS) scores below -3 and above 3, the score was adjusted as described in the WHO instruction. This outcome measure is applicable only for the Liraglutide 1.8 mg treatment arm.
Query!
Timepoint [76]
0
0
Week 0, week 156
Query!
Secondary outcome [77]
0
0
Change From Week 52 in Height SDS- Week 156
Query!
Assessment method [77]
0
0
Change in height SDS from week 52 to week 156. Height SDS was calculated using the following formula: Z=\[(value /M)\^L - 1\] / S\*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' height provided for each sex and age. For each subject, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. The method is described in the WHO Multicentre Growth Reference, which also contains the values for L, M and S by age and sex. For Z (SDS) scores below -3 and above 3, the score was adjusted as described in the WHO instruction. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. This outcome measure is applicable only for the Liraglutide 1.8 mg treatment arm.
Query!
Timepoint [77]
0
0
Week 52, week 156
Query!
Secondary outcome [78]
0
0
Change in Pubertal Assessment/Progression (Tanner Staging)- Week 156
Query!
Assessment method [78]
0
0
Pubertal development was assessed in 3 areas (breast, penis and pubic hair development) by the Tanner staging in accordance with stages I-V, where stage I represents "pre-adoloscent development" and stage V represents "pubertal development equivalent to that of an adult". The Tanner staging assessment was no longer required to be performed once a subject reached the Tanner stage V, as judged by the investigator. Reported results are number of subjects at different Tanner stages at week 52 and week 156. This outcome measure is applicable only for the Liraglutide 1.8 mg treatment arm.
Query!
Timepoint [78]
0
0
Week 52, week 156
Query!
Secondary outcome [79]
0
0
Change From Week 52 in Bone Age Assessment (X-ray of Left Hand and Wrist)- Week 156
Query!
Assessment method [79]
0
0
Change in bone age from week 52 to week 156. This outcome measure is applicable only for the Liraglutide 1.8 mg treatment arm.
Query!
Timepoint [79]
0
0
Week 52, week 156
Query!
Eligibility
Key inclusion criteria
- Children and adolescents between the ages of 10-16 years. Subjects cannot turn 17 years and 11 months before the end of treatment (52 weeks) - Diagnosis of type 2 diabetes mellitus and treated for at least 30 days with: diet and exercise alone, diet and exercise in combination with metformin monotherapy, diet and exercise in combination with metformin and a stable (Stable is defined as basal insulin adjustments up to 15%) dose of basal insulin, diet and exercise in combination with a stable (Stable is defined as basal insulin adjustments up to 15%) dose of basal insulin - HbA1c: 7.0-11% (inclusive) if diet and exercise treated or 6.5-11% (inclusive) if treated with metformin as monotherapy, basal insulin as monotherapy or metformin and basal insulin in combination - Body mass index (BMI) above 85% percentile of the general age and gender matched population
Query!
Minimum age
10
Years
Query!
Query!
Maximum age
17
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
- Type 1 diabetes - Maturity onset diabetes of the young (MODY) - Use of any antidiabetic agent other than metformin and/or basal insulin within 90 days prior to screening - Recurrent severe hypoglycaemia or hypoglycaemic unawareness as judged by the investigator - History of chronic pancreatitis or idiopathic acute pancreatitis - Any clinically significant disorder, except for conditions associated with type 2 diabetes history which in the investigator's opinion could interfere with results of the trial - Uncontrolled hypertension, treated or untreated above 99th percentile for age and gender in children - Known or suspected abuse of alcohol or drugs/narcotics
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
13/11/2012
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
20/05/2020
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
135
Query!
Recruitment in Australia
Recruitment state(s)
QLD
Query!
Recruitment hospital [1]
0
0
Novo Nordisk Investigational Site - Ipswich
Query!
Recruitment postcode(s) [1]
0
0
4305 - Ipswich
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Alabama
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Arizona
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
California
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Connecticut
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Delaware
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
District of Columbia
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Florida
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Georgia
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Indiana
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Iowa
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Kansas
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Kentucky
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Maryland
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Massachusetts
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
Michigan
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
Minnesota
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
Missouri
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
Nevada
Query!
Country [19]
0
0
United States of America
Query!
State/province [19]
0
0
New Jersey
Query!
Country [20]
0
0
United States of America
Query!
State/province [20]
0
0
New York
Query!
Country [21]
0
0
United States of America
Query!
State/province [21]
0
0
Ohio
Query!
Country [22]
0
0
United States of America
Query!
State/province [22]
0
0
Pennsylvania
Query!
Country [23]
0
0
United States of America
Query!
State/province [23]
0
0
South Carolina
Query!
Country [24]
0
0
United States of America
Query!
State/province [24]
0
0
South Dakota
Query!
Country [25]
0
0
United States of America
Query!
State/province [25]
0
0
Tennessee
Query!
Country [26]
0
0
United States of America
Query!
State/province [26]
0
0
Texas
Query!
Country [27]
0
0
United States of America
Query!
State/province [27]
0
0
Virginia
Query!
Country [28]
0
0
United States of America
Query!
State/province [28]
0
0
West Virginia
Query!
Country [29]
0
0
Austria
Query!
State/province [29]
0
0
Graz
Query!
Country [30]
0
0
Austria
Query!
State/province [30]
0
0
Innsbruck
Query!
Country [31]
0
0
Austria
Query!
State/province [31]
0
0
Salzburg
Query!
Country [32]
0
0
Austria
Query!
State/province [32]
0
0
Wels
Query!
Country [33]
0
0
Belgium
Query!
State/province [33]
0
0
Brussel
Query!
Country [34]
0
0
Belgium
Query!
State/province [34]
0
0
Bruxelles
Query!
Country [35]
0
0
Belgium
Query!
State/province [35]
0
0
Leuven
Query!
Country [36]
0
0
Brazil
Query!
State/province [36]
0
0
Rio Grande Do Sul
Query!
Country [37]
0
0
Canada
Query!
State/province [37]
0
0
Alberta
Query!
Country [38]
0
0
Canada
Query!
State/province [38]
0
0
Manitoba
Query!
Country [39]
0
0
Canada
Query!
State/province [39]
0
0
Ontario
Query!
Country [40]
0
0
Canada
Query!
State/province [40]
0
0
Quebec
Query!
Country [41]
0
0
Croatia
Query!
State/province [41]
0
0
Rijeka
Query!
Country [42]
0
0
Croatia
Query!
State/province [42]
0
0
Zagreb
Query!
Country [43]
0
0
Denmark
Query!
State/province [43]
0
0
Herlev
Query!
Country [44]
0
0
Denmark
Query!
State/province [44]
0
0
Næstved
Query!
Country [45]
0
0
Egypt
Query!
State/province [45]
0
0
Alexandria
Query!
Country [46]
0
0
Egypt
Query!
State/province [46]
0
0
Cairo
Query!
Country [47]
0
0
Egypt
Query!
State/province [47]
0
0
Mansoura
Query!
Country [48]
0
0
France
Query!
State/province [48]
0
0
Marseille
Query!
Country [49]
0
0
France
Query!
State/province [49]
0
0
MONTPELLIER cedex 05
Query!
Country [50]
0
0
Germany
Query!
State/province [50]
0
0
Ludwigshafen
Query!
Country [51]
0
0
Germany
Query!
State/province [51]
0
0
Mayen
Query!
Country [52]
0
0
Greece
Query!
State/province [52]
0
0
Athens
Query!
Country [53]
0
0
Greece
Query!
State/province [53]
0
0
Goudi/ Athens
Query!
Country [54]
0
0
Greece
Query!
State/province [54]
0
0
Thessaloniki
Query!
Country [55]
0
0
Hungary
Query!
State/province [55]
0
0
Budapest
Query!
Country [56]
0
0
Hungary
Query!
State/province [56]
0
0
Miskolc
Query!
Country [57]
0
0
Hungary
Query!
State/province [57]
0
0
Szombathely
Query!
Country [58]
0
0
India
Query!
State/province [58]
0
0
Andhra Pradesh
Query!
Country [59]
0
0
India
Query!
State/province [59]
0
0
Karnataka
Query!
Country [60]
0
0
India
Query!
State/province [60]
0
0
Maharashtra
Query!
Country [61]
0
0
India
Query!
State/province [61]
0
0
New Delhi
Query!
Country [62]
0
0
India
Query!
State/province [62]
0
0
Punjab
Query!
Country [63]
0
0
India
Query!
State/province [63]
0
0
Rajasthan
Query!
Country [64]
0
0
India
Query!
State/province [64]
0
0
Tamil Nadu
Query!
Country [65]
0
0
India
Query!
State/province [65]
0
0
Telengana
Query!
Country [66]
0
0
India
Query!
State/province [66]
0
0
West Bengal
Query!
Country [67]
0
0
India
Query!
State/province [67]
0
0
Kolkata
Query!
Country [68]
0
0
Israel
Query!
State/province [68]
0
0
Beer Sheva
Query!
Country [69]
0
0
Israel
Query!
State/province [69]
0
0
Haifa
Query!
Country [70]
0
0
Israel
Query!
State/province [70]
0
0
Jerusalem
Query!
Country [71]
0
0
Israel
Query!
State/province [71]
0
0
Petah Tikva
Query!
Country [72]
0
0
Israel
Query!
State/province [72]
0
0
Tel Hashomer
Query!
Country [73]
0
0
Italy
Query!
State/province [73]
0
0
Roma
Query!
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Novo Nordisk A/S
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Ethics approval
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Summary
Brief summary
This trial is conducted globally. The aim of this trial is to assess the efficacy and safety of liraglutide in the paediatric population in order to potentially address the unmet need for treatment of children and adolescents with type 2 diabetes.
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Trial website
https://clinicaltrials.gov/study/NCT01541215
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Trial related presentations / publications
Tamborlane WV, Barrientos-Perez M, Fainberg U, Frimer-Larsen H, Hafez M, Hale PM, Jalaludin MY, Kovarenko M, Libman I, Lynch JL, Rao P, Shehadeh N, Turan S, Weghuber D, Barrett T; Ellipse Trial Investigators. Liraglutide in Children and Adolescents with Type 2 Diabetes. N Engl J Med. 2019 Aug 15;381(7):637-646. doi: 10.1056/NEJMoa1903822. Epub 2019 Apr 28. Bensignor MO, Bomberg EM, Bramante CT, Divyalasya TVS, Hale PM, Ramesh CK, Rudser KD, Kelly AS. Effect of liraglutide treatment on body mass index and weight parameters in children and adolescents with type 2 diabetes: Post hoc analysis of the ellipse trial. Pediatr Obes. 2021 Aug;16(8):e12778. doi: 10.1111/ijpo.12778. Epub 2021 Feb 25.
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Public notes
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Contacts
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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When will data be available (start and end dates)?
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Available to whom?
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: http://novonordisk-trials.com/sharing-results
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What supporting documents are/will be available?
No Supporting Document Provided
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Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/15/NCT01541215/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/15/NCT01541215/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT01541215