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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00318461
Registration number
NCT00318461
Ethics application status
Date submitted
25/04/2006
Date registered
26/04/2006
Date last updated
7/03/2017
Titles & IDs
Public title
To Compare the Effect of Liraglutide When Given Together With Metformin With the Effect of Metformin Given Alone and With the Effect of Glimepiride and Metformin Given Together
Query!
Scientific title
Liraglutide Effect and Action in Diabetes (LEAD-2): Effect on Glycaemic Control After Once Daily Administration of Liraglutide in Combination With Metformin Versus Metformin Monotherapy Versus Metformin and Glimepiride Combination Therapy in Subjects With Type 2 Diabetes
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Secondary ID [1]
0
0
NN2211-1572
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Universal Trial Number (UTN)
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Trial acronym
LEAD-2
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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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0
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Diabetes Mellitus, Type 2
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0
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Condition category
Condition code
Metabolic and Endocrine
0
0
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0
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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 - metformin
Treatment: Drugs - glimepiride
Treatment: Drugs - placebo
Treatment: Drugs - placebo
Treatment: Drugs - liraglutide
Treatment: Drugs - liraglutide
Experimental: Lira 0.6 + Met - Liraglutide 0.6 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day
Experimental: Lira 1.2 + Met - Liraglutide 1.2 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day
Experimental: Lira 1.8 + Met - Liraglutide 1.8 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day
Active Comparator: Met Mono - Metformin 1.5-2.0 g/day + liraglutide placebo + glimepiride placebo
Active Comparator: Met + Glim - Glimepiride 4 mg/day + metformin 1.5-2.0 g/day + liraglutide placebo
Treatment: Drugs: liraglutide
0.6 mg for s.c. (under the skin) injection.
Treatment: Drugs: metformin
1.5-2.0 g tablets
Treatment: Drugs: glimepiride
4 mg tablets
Treatment: Drugs: placebo
Glimepiride placebo 1 mg and 2 mg tablets
Treatment: Drugs: placebo
Liraglutide placebo 1-3 mL for s.c. (under the skin) injection
Treatment: Drugs: liraglutide
1.2 mg for s.c. (under the skin) injection
Treatment: Drugs: liraglutide
1.8 mg for s.c. (under the skin) injection
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Intervention code [1]
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0
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 Glycosylated A1c (HbA1c) at Week 26
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Assessment method [1]
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Percentage point change in Glycosylated A1c (HbA1c) from baseline (week 0) to 26 weeks (end of randomisation)
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Timepoint [1]
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0
week 0, week 26
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Primary outcome [2]
0
0
Change in Glycosylated A1c (HbA1c) at Week 104
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Assessment method [2]
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0
Change in glycosylated A1c (HbA1c) baseline (week 0) to 104 weeks (end of randomisation)
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Timepoint [2]
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0
week 0, week 104
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Secondary outcome [1]
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Change in Body Weight at Week 26
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Assessment method [1]
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Change in body weight from baseline (week 0) to 26 weeks (end of randomisation)
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Timepoint [1]
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0
week 0, week 26
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Secondary outcome [2]
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0
Change in Body Weight at Week 104
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Assessment method [2]
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Change in body weight from baseline (week 0) to 104 weeks (end of treatment)
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Timepoint [2]
0
0
week 0, week 104
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Secondary outcome [3]
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Change in Fasting Plasma Glucose (FPG) at Week 26
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Assessment method [3]
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Change in fasting plasma glucose (FPG) from baseline (week 0) to 26 weeks (end of randomisation)
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Timepoint [3]
0
0
week 0, week 26
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Secondary outcome [4]
0
0
Change in Fasting Plasma Glucose (FPG) at Week 104
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Assessment method [4]
0
0
Change in Fasting plasma glucose (FPG) from baseline (week 0) to 104 weeks (end of treatment)
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Timepoint [4]
0
0
week 0, week 104
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Secondary outcome [5]
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Change in Mean Prandial Increments of Plasma Glucose Based on Self-measured 7-point Plasma Glucose Profiles at Week 26
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Assessment method [5]
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Change in mean prandial increments of plasma glucose based on self-measured 7-point plasma glucose profiles from baseline (week 0) to 26 weeks (end of randomisation). The 7 time points for self-measurements were: before each meal (breakfast, lunch and dinner), at 90 min after start of each meal (breakfast, lunch and dinner) and at bedtime.
Mean prandial increments of plasma glucose were calculated as the sum of the plasma glucose differences between values measured before and after a meal (breakfast, lunch and dinner) divided by three.
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Timepoint [5]
0
0
week 0, week 26
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Secondary outcome [6]
0
0
Change in Mean Prandial Increments of Plasma Glucose Based on Self-measured 7-point Plasma Glucose Profiles at Week 104
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Assessment method [6]
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Change in mean prandial increments of plasma glucose based on self-measured 7-point plasma glucose profiles from baseline (week 0) to 104 weeks (end of treatment). The 7 time points for self-measurements were: before each meal (breakfast, lunch and dinner), at 90 min after start of each meal (breakfast, lunch and dinner) and at bedtime.
Mean prandial increments of plasma glucose were calculated as the sum of the plasma glucose differences between values measured before and after a meal (breakfast, lunch and dinner) divided by three.
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Timepoint [6]
0
0
week 0, week 104
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Secondary outcome [7]
0
0
Change in Mean Post Prandial Plasma Glucose Based on Self-measured 7-point Plasma Glucose Profiles at Week 26
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Assessment method [7]
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Change in mean post prandial plasma glucose from baseline (Week 0) to 26 weeks (end of randomisation). The 7 time points for self-measurements were: before each meal (breakfast, lunch and dinner), at 90 min after start of each meal (breakfast, lunch and dinner) and at bedtime. Mean post prandial plasma glucose were calculated as the sum of the post pradial plasma glucose values divided by three.
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Timepoint [7]
0
0
week 0, week 26
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Secondary outcome [8]
0
0
Change in Mean Post Prandial Plasma Glucose Based on Self-measured 7-point Plasma Glucose Profiles at Week 104
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Assessment method [8]
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0
Change in mean post prandial plasma glucose from baseline (Week 0) to 104 weeks (end of treatment) The 7 time points for self-measurements were: before each meal (breakfast, lunch and dinner), at 90 min after start of each meal (breakfast, lunch and dinner) and at bedtime. Mean post prandial plasma glucose were calculated as the sum of the post pradial plasma glucose values divided by three.
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Timepoint [8]
0
0
week 0, week 104
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Secondary outcome [9]
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Change in Beta-cell Function at Week 26
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Assessment method [9]
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Change in beta cell function from baseline (week 0) to 16 weeks (end of treatment). Beta-cell function was derived from fasting plasma glucose (FPG) and fasting insulin concentrations using the homeostasic model assessment (HOMA) method which uses the assumption that normal-weight normal subjects aged under 35 years have a 100% beta-cell function (HOMA-B).
Beta-cell function: HOMA-B (%) = 20·fasting insulin[uU/mL] divided by (FPG mmol/L]-3.5).
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Timepoint [9]
0
0
week 0, week 26
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Secondary outcome [10]
0
0
Change in Beta-cell Function at Week 104
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Assessment method [10]
0
0
Change in beta cell function from baseline (week 0) to 16 weeks (end of treatment). Beta-cell function was derived from fasting plasma glucose (FPG) and fasting insulin concentrations using the homeostasic model assessment (HOMA) method which uses the assumption that normal-weight normal subjects aged under 35 years have a 100% beta-cell function (HOMA-B).
Beta-cell function: HOMA-B (%) = 20·fasting insulin[uU/mL] divided by (FPG mmol/L]-3.5).
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Timepoint [10]
0
0
week 0, week 104
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Secondary outcome [11]
0
0
Hypoglycaemic Episodes at Week 26
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Assessment method [11]
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Total number of hypoglycaemic episodes occuring after baseline (week 0) until week 26 (end of randomisation). Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose was below 3.1 mmol/L. Symptoms only if subject was able to treat her/himself and with no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.
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Timepoint [11]
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0
weeks 0-26
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Secondary outcome [12]
0
0
Hypoglycaemic Episodes at Week 104
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Assessment method [12]
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Total number of hypoglycaemic episodes occuring after baseline (week 0) until 104 weeks (end of treatment). Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose was below 3.1 mmol/L. Symptoms only if subject was able to treat her/himself and with no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.
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Timepoint [12]
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0
weeks 0-104
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Eligibility
Key inclusion criteria
- Subjects diagnosed with type 2 diabetes and treated with oral anti-diabetic drugs
(OADs) for at least 3 months
- HbA1c: 7.0-11.0 % (both incl.) in subjects on OAD monotherapy. 7.0-10.0 % (both incl.)
in subjects on OAD combination therapy
- Body Mass Index (BMI) less than or equal 40 kg/m2
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Minimum age
18
Years
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Maximum age
80
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Subjects treated with insulin within the last three months
- Subjects with any serious medical condition
- Females of child bearing potential who are pregnant, breast-feeding or have the
intention of becoming pregnant or not using adequate contraceptive methods
- Subjects using any drug (except for OADs), which in the Investigator's opinion could
interfere with the glucose level (e.g. systemic corticosteroids)
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/05/2006
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/11/2008
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Sample size
Target
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Accrual to date
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Final
1091
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Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC,WA
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Recruitment hospital [1]
0
0
Novo Nordisk Investigational Site - Broadmeadow
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Recruitment hospital [2]
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0
Novo Nordisk Investigational Site - Penrith
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Recruitment hospital [3]
0
0
Novo Nordisk Investigational Site - St Leonards
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Recruitment hospital [4]
0
0
Novo Nordisk Investigational Site - Daw Park
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Recruitment hospital [5]
0
0
Novo Nordisk Investigational Site - East Ringwood
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Recruitment hospital [6]
0
0
Novo Nordisk Investigational Site - Fremantle
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Recruitment hospital [7]
0
0
Novo Nordisk Investigational Site - Adelaide
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Recruitment hospital [8]
0
0
Novo Nordisk Investigational Site - Auckland
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Recruitment hospital [9]
0
0
Novo Nordisk Investigational Site - Bankstown
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Recruitment hospital [10]
0
0
Novo Nordisk Investigational Site - Box Hill
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Recruitment hospital [11]
0
0
Novo Nordisk Investigational Site - Cairns
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Recruitment hospital [12]
0
0
Novo Nordisk Investigational Site - Camperdown
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Recruitment hospital [13]
0
0
Novo Nordisk Investigational Site - Christchurch
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Recruitment hospital [14]
0
0
Novo Nordisk Investigational Site - Clayton
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Recruitment hospital [15]
0
0
Novo Nordisk Investigational Site - Fitzroy
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Recruitment hospital [16]
0
0
Novo Nordisk Investigational Site - Garran
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Recruitment hospital [17]
0
0
Novo Nordisk Investigational Site - Hornsby
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Recruitment hospital [18]
0
0
Novo Nordisk Investigational Site - Malvern
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Recruitment hospital [19]
0
0
Novo Nordisk Investigational Site - Perth
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Recruitment hospital [20]
0
0
Novo Nordisk Investigational Site - Westmead
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Recruitment hospital [21]
0
0
Novo Nordisk Investigational Site - Woodville
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Recruitment postcode(s) [1]
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0
2292 - Broadmeadow
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Recruitment postcode(s) [2]
0
0
2751 - Penrith
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Recruitment postcode(s) [3]
0
0
2065 - St Leonards
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Recruitment postcode(s) [4]
0
0
5041 - Daw Park
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Recruitment postcode(s) [5]
0
0
3135 - East Ringwood
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Recruitment postcode(s) [6]
0
0
6160 - Fremantle
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Recruitment postcode(s) [7]
0
0
5000 - Adelaide
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Recruitment postcode(s) [8]
0
0
SA 5035 - Adelaide
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Recruitment postcode(s) [9]
0
0
- Auckland
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Recruitment postcode(s) [10]
0
0
2200 - Bankstown
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Recruitment postcode(s) [11]
0
0
3128 - Box Hill
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Recruitment postcode(s) [12]
0
0
4870 - Cairns
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Recruitment postcode(s) [13]
0
0
2050 - Camperdown
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Recruitment postcode(s) [14]
0
0
8011 - Christchurch
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Recruitment postcode(s) [15]
0
0
3168 - Clayton
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Recruitment postcode(s) [16]
0
0
3065 - Fitzroy
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Recruitment postcode(s) [17]
0
0
2605 - Garran
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Recruitment postcode(s) [18]
0
0
2077 - Hornsby
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Recruitment postcode(s) [19]
0
0
3144 - Malvern
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Recruitment postcode(s) [20]
0
0
6000 - Perth
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Recruitment postcode(s) [21]
0
0
2145 - Westmead
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Recruitment postcode(s) [22]
0
0
5011 - Woodville
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Recruitment outside Australia
Country [1]
0
0
Argentina
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State/province [1]
0
0
Ciudad Autonoma de Bs As
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Country [2]
0
0
Argentina
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State/province [2]
0
0
Ciudad Autónoma de Bs As
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Country [3]
0
0
Argentina
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State/province [3]
0
0
Ciudad Autónoma de BsAs
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Country [4]
0
0
Argentina
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State/province [4]
0
0
Junín
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Country [5]
0
0
Belgium
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State/province [5]
0
0
Arlon
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Country [6]
0
0
Belgium
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State/province [6]
0
0
Bonheiden
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Country [7]
0
0
Belgium
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State/province [7]
0
0
Gent
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Country [8]
0
0
Belgium
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State/province [8]
0
0
Huy
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Country [9]
0
0
Belgium
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State/province [9]
0
0
La Louvière
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Country [10]
0
0
Belgium
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State/province [10]
0
0
Leuven
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Country [11]
0
0
Bulgaria
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State/province [11]
0
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Sofia
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Country [12]
0
0
Croatia
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State/province [12]
0
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Zagreb
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Country [13]
0
0
Denmark
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State/province [13]
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Aalborg
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Country [14]
0
0
Denmark
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State/province [14]
0
0
Frederiksberg
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Country [15]
0
0
Denmark
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State/province [15]
0
0
Herlev
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Country [16]
0
0
Denmark
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State/province [16]
0
0
Hjørring
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Country [17]
0
0
Denmark
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State/province [17]
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Hvidovre
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Country [18]
0
0
Denmark
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State/province [18]
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København S
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Country [19]
0
0
Denmark
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State/province [19]
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København
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0
0
Denmark
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State/province [20]
0
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Odense
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Country [21]
0
0
Denmark
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State/province [21]
0
0
Viborg
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Country [22]
0
0
Denmark
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State/province [22]
0
0
Århus C
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Country [23]
0
0
Germany
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State/province [23]
0
0
Aschaffenburg
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Country [24]
0
0
Germany
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State/province [24]
0
0
Bad Heilbrunn
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Country [25]
0
0
Germany
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State/province [25]
0
0
Bad Kreuznach
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Country [26]
0
0
Germany
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State/province [26]
0
0
Bad Lauterberg
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Country [27]
0
0
Germany
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State/province [27]
0
0
Bad Mergentheim
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Country [28]
0
0
Germany
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State/province [28]
0
0
Bad Neuenahr-Ahrweiler
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Country [29]
0
0
Germany
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State/province [29]
0
0
Beckum
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Country [30]
0
0
Germany
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State/province [30]
0
0
Bensheim
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Country [31]
0
0
Germany
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State/province [31]
0
0
Berlin
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0
0
Germany
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State/province [32]
0
0
Darmstadt
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Country [33]
0
0
Germany
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State/province [33]
0
0
Diez
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Country [34]
0
0
Germany
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State/province [34]
0
0
Dormagen
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Country [35]
0
0
Germany
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State/province [35]
0
0
Dresden
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Country [36]
0
0
Germany
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State/province [36]
0
0
Flensburg
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Country [37]
0
0
Germany
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State/province [37]
0
0
Großheirath
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Country [38]
0
0
Germany
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State/province [38]
0
0
Halle
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Country [39]
0
0
Germany
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State/province [39]
0
0
Hamburg
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Country [40]
0
0
Germany
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State/province [40]
0
0
Kutenholz-Mulsum
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Country [41]
0
0
Germany
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State/province [41]
0
0
Köln
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Country [42]
0
0
Germany
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State/province [42]
0
0
Ludwigshafen
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Country [43]
0
0
Germany
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State/province [43]
0
0
Marburg
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Country [44]
0
0
Germany
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State/province [44]
0
0
Münster
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Country [45]
0
0
Germany
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State/province [45]
0
0
Neuwied
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0
0
Germany
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State/province [46]
0
0
Oberhausen
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Country [47]
0
0
Germany
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State/province [47]
0
0
Pirna
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Country [48]
0
0
Germany
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State/province [48]
0
0
Pohlheim
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Country [49]
0
0
Germany
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State/province [49]
0
0
Regensburg
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Country [50]
0
0
Germany
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State/province [50]
0
0
Rehlingen-Siersburg
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Country [51]
0
0
Germany
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State/province [51]
0
0
Saaldorf-Surheim
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Country [52]
0
0
Germany
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State/province [52]
0
0
Saarbrücken
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Country [53]
0
0
Germany
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State/province [53]
0
0
Speyer
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Country [54]
0
0
Germany
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State/province [54]
0
0
St. Ingbert
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Country [55]
0
0
Germany
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State/province [55]
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0
Stuttgart
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0
0
Germany
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State/province [56]
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0
Sulzbach-Rosenberg
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0
0
Germany
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0
0
Tübingen
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0
0
Germany
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State/province [58]
0
0
Viersen
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Country [59]
0
0
Germany
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State/province [59]
0
0
Völklingen
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Country [60]
0
0
Germany
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State/province [60]
0
0
Würzburg
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Country [61]
0
0
Hungary
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State/province [61]
0
0
Budapest
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Country [62]
0
0
Hungary
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State/province [62]
0
0
Debrecen
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Country [63]
0
0
Hungary
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State/province [63]
0
0
Gyula
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Country [64]
0
0
Hungary
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State/province [64]
0
0
Nyíregyháza
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Country [65]
0
0
Hungary
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State/province [65]
0
0
Pecs
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Country [66]
0
0
Hungary
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State/province [66]
0
0
Szekszárd
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Country [67]
0
0
Hungary
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State/province [67]
0
0
Zalaegerszeg
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Country [68]
0
0
India
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State/province [68]
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0
Andhra Pradesh
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Country [69]
0
0
India
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State/province [69]
0
0
Kerala
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Country [70]
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India
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Maharashtra
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India
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India
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Ireland
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Dublin
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Waterford
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Bari
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Italy
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Catania
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Italy
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Firenze
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Italy
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Milano
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Italy
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Monza
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Italy
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Orbassano
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Italy
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Padova
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Italy
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Palermo
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Italy
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Rimini
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Italy
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Roma
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Italy
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Sassari
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Italy
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Torino
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Italy
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Verona
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Apeldoorn
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Groningen
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Rotterdam
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Netherlands
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Sliedrecht
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Norway
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Bekkestua
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Norway
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Norway
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Norway
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Norway
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Trondheim
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Cluj
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Constanta
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Iasi
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Moldava nad Bodvou
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Presov
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Trencin
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Gauteng
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KwaZulu-Natal
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South Africa
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Western Cape
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South Africa
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Benoni
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Spain
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Alcazar de San Juan
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Spain
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Almería
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Spain
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Barcelona
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Bilbao
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Cádiz
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Girona
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Granada
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La Coruña
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La Laguna
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Spain
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Málaga
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Spain
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Mérida
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San Juan
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Santa Cruz de Tenerife
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Sevilla
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Falun
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Karlstad
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Linköping
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Sweden
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Lund
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Sweden
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Malmö
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Stockholm
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Sweden
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Umeå
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United Kingdom
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Abergavenny
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Bath
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Berkshire
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Cardiff
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Coventry
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United Kingdom
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Dundee
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United Kingdom
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East Horsley
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United Kingdom
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Frome
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United Kingdom
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Llanelli
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United Kingdom
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Oxford
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United Kingdom
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Plymouth
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United Kingdom
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Sheffield
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United Kingdom
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Sunbury on Thames
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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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Address
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Ethics approval
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Summary
Brief summary
This trial is conducted in Europe, Oceania, Africa, Asia and South America. This trial is
designed to show the effect of treatment with liraglutide when adding to existing metformin
therapy and to compare it with the effects of metformin monotherapy and combination therapy
of metformin and glimepiride. Two trial periods: A 6 month (26 weeks) randomised,
double-blinded period followed by an 18 months open-label extension, in total 2 years (104
weeks).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00318461
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Public notes
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Contacts
Principal investigator
Name
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0
Global Clinical Registry (GCR, 1452)
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Address
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Novo Nordisk A/S
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00318461
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