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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/NCT00607087
Registration number
NCT00607087
Ethics application status
Date submitted
23/01/2008
Date registered
5/02/2008
Date last updated
31/08/2010
Titles & IDs
Public title
Effect of Insulin Glulisine Compared to Insulin Aspart and Insulin Lispro When Administered by Continuous Subcutaneous Insulin Infusion (CSII) on Specific Pump Parameters in Patient With Type 1 Diabetes Mellitus
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Scientific title
Effect of Insulin Glulisine Compared to Insulin Aspart and Insulin Lispro When Administered by Continuous Subcutaneous Insulin Infusion (CSII) on Specific Pump Parameters in Patient With Type 1 Diabetes Mellitus
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Secondary ID [1]
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2007-003579-38
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Secondary ID [2]
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APIDR_C_02083
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Universal Trial Number (UTN)
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Trial acronym
PUMP
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Diabetes Mellitus, Type 1
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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 - Insulin glulisine
Treatment: Drugs - Insulin lispro
Treatment: Drugs - Insulin aspart
Experimental: sequence 1 - sequence 1: insulin glulisine / insulin aspart / insulin lispro.
Experimental: Sequence 2 - Sequence 2: insulin aspart / insulin lispro / insulin glulisine
Experimental: Sequence 3 - Sequence 3: insulin lispro / insulin glulisine / insulin aspart
Treatment: Drugs: Insulin glulisine
100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
Treatment: Drugs: Insulin lispro
100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
Treatment: Drugs: Insulin aspart
100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
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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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Percentage of Patients With at Least One Unexplained Hyperglycemia and/ or Confirmed Infusion Set Occlusion
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Assessment method [1]
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Unexplained hyperglycemia defined as blood glucose value above 300 mg/dL (16.7 mmol/L) with no apparent medical dietary, insulin dosage or pump failure reason.
Pump infusion set occlusion defined by at least one of the following items:
pump occlusion alarm,
patient observation of an occlusion, spontaneously or because of elevated blood glucose value.
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Timepoint [1]
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over 13 weeks of each treatment period
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Secondary outcome [1]
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Monthly Rate of Unexplained Hyperglycemia and/ or Confirmed Infusion Set Occlusion
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Assessment method [1]
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Unexplained hyperglycemia defined as blood glucose value above 300 mg/dL (16.7 mmol/L) with no apparent medical dietary, insulin dosage or pump failure reason.
Pump infusion set occlusion defined by at least one of the following items:
pump occlusion alarm,
patient observation of an occlusion, spontaneously or because of elevated blood glucose value.
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Timepoint [1]
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over 13 weeks of each treatment period
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Secondary outcome [2]
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Percentage of Patients With at Least One Unexplained Hyperglycemia
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Assessment method [2]
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Unexplained hyperglycemia defined as blood glucose value above 300 mg/dL (16.7 mmol/L) with no apparent medical dietary, insulin dosage or pump failure reason.
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Timepoint [2]
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over 13 weeks of each treatment period
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Secondary outcome [3]
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Monthly Rate of Unexplained Hyperglycemia
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Assessment method [3]
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Timepoint [3]
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over 13 weeks of each treatment period
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Secondary outcome [4]
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Percentage of Patients With at Least One Confirmed Infusion Set Occlusion
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Assessment method [4]
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Pump infusion set occlusion defined by at least one of the following items:
pump occlusion alarm,
patient observation of an occlusion, spontaneously or because of elevated blood glucose value.
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Timepoint [4]
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over 13 weeks of each treatment period
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Secondary outcome [5]
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Monthly Rate of Confirmed Infusion Set Occlusion
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Assessment method [5]
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Timepoint [5]
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over 13 weeks of each treatment period
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Secondary outcome [6]
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Percentage of Patients With at Least One Episode of Significant Ketosis and/ or Risk Level for Impending Diabetic Ketoacidosis
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Assessment method [6]
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Diabetic ketoacidosis (DKA) is preceded by an increase in ketone production, resulting in blood ketone value increase (hyperketonemia) and later in ketone urine value (hyperketonuria).
Significant hyperketonemia and risk level for impending diabetic ketoacidosis (DKA) are reported respectively as a blood ketone value from 0.6 to 1.5 mmol/L and >1.5 mmol/l
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Timepoint [6]
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over 13 weeks of each treatment period
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Secondary outcome [7]
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Monthly Rate of Episode of Significant Ketosis and/ or Risk Level for Impending Diabetic Ketoacidosis
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Assessment method [7]
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Diabetic ketoacidosis (DKA) is preceded by an increase in ketone production, resulting in blood ketone value increase (hyperketonemia) and later in ketone urine value (hyperketonuria).
Significant hyperketonemia and risk level for impending diabetic ketoacidosis (DKA) are reported respectively as a blood ketone value from 0.6 to 1.5 mmol/L and >1.5 mmol/l
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Timepoint [7]
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over 13 weeks of each treatment period
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Secondary outcome [8]
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Rate of Symptomatic Hypoglycemia With a Plasma Glucose (PG) = 70 mg/dL Per Patient-year
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Assessment method [8]
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Symptomatic hypoglycemia is defined as an event with clinical symptoms that are considered to results from hypoglycemia (confirmed or not by a glucose measurement) and associated with prompt recovery after oral carbohydrate administration.
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Timepoint [8]
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over 13 weeks of each treatment period
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Secondary outcome [9]
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Rate of Severe Symptomatic Hypoglycemia Per Patient-year
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Assessment method [9]
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Severe symptomatic hypoglycemia is defined as an event with clinical symptoms that are considered to results from hypoglycemia in which the patient required assistance of another person and one of the following:
the event was associated with a measured blood glucose level below 36 mg/dL
or event was associated with prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration.
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Timepoint [9]
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over 13 weeks of each treatment period
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Secondary outcome [10]
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Rate of Nocturnal Symptomatic Hypoglycemia With a Plasma Glucose (PG) =70 mg/dL Per Patient-year
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Assessment method [10]
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Nocturnal Symptomatic hypoglycemia was defined as an event with clinical symptoms that are considered to result from hypoglycemia (confirmed or not by a glucose measurement) and associated with prompt recovery after oral carbohydrate administration which occurs while the patient is asleep, after bedtime and before getting up in the morning.
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Timepoint [10]
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over 13 weeks of each treatment period
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Secondary outcome [11]
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Patients With at Least One Site Infection, Site Inflammation/Erythema, Pruritus or Isolated Pain at Injection Site
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Assessment method [11]
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Infection: local reaction at the infusion site requiring local or systemic antibiotherapy, or local drainage as per Investigator judgment.
Site inflammation or erythema: local reaction at the infusion site with no need for local or systemic antibiotherapy as per Investigator judgment.
Pruritis at injection site: presence of pruritis at the infusion site without any symptom of inflammation or erythema and/or infection.
Isolated pain at injection site: presence of pain at the infusion site without any symptom of inflammation or erythema and/or infection.
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Timepoint [11]
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over 13 weeks of each treatment period
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Secondary outcome [12]
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Time Interval Between Infusion Set Changes: All Changes
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Assessment method [12]
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Patients treated with insulin pump have to change their infusion set regularly (i.e.change was recommended every 48h). The patients were asked to report any change of their infusion set and the reason for change (routine basis or because of occurrence of a specific event such as occlusion, unexplained hyperglycemia or adverse event).
"All changes" include all the changes whatever the reason such as routine or requested by occurrence of events.
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Timepoint [12]
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over 13 weeks of each treatment period
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Secondary outcome [13]
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Time Interval Between Infusion Set Changes in Routine
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Assessment method [13]
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Patients treated with insulin pump have to change their infusion set regularly (i.e.change was recommended every 48h). The patients were asked to report any change of their infusion set and the reason for change (routine basis or because of occurrence of a specific event such as occlusion, unexplained hyperglycemia or adverse event).
Changes in routine correspond to interval between changes according to patient use.
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Timepoint [13]
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over 13 weeks of each treatment period
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Secondary outcome [14]
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Glycosylated Hemoglobin: HbA1c
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Assessment method [14]
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Glycolysated Haemoglobin (HbA1c) is a biological parameter that reflects the blood glucose concentration over a long period of time. It is the standard parameter for glycemic control follow-up in diabetic patients. This parameter is expressed in percentage (%) and the target in diabetes management is to reach a HbA1c <7%
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Timepoint [14]
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over 13 weeks of each treatment period
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Secondary outcome [15]
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Total Daily Basal Insulin Infusion
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Assessment method [15]
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dose of the basal insulin regimen administered throughout the 24-hour period
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Timepoint [15]
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over 13 weeks of each treatment period
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Secondary outcome [16]
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Total Daily Bolus Insulin Dose
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Assessment method [16]
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dose of every increment administered for example before meals
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Timepoint [16]
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over 13 weeks of each treatment period
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Eligibility
Key inclusion criteria
- Type 1 diabetic subjects
- Treated with insulin for at least 2 years and by CSII for at least 6 months
- Using the same insulin (insulin glulisine, insulin aspart or insulin lispro) in CSII
for at least 3 months with the same external pump compatible with the 3 short acting
insulin analogues used in the study
- Using the same type of infusion set (catheter and cannula) for at least 3 months
- Performing at least 3 blood glucose controls per day
- HbA1c < 8.5%
- Body mass index (BMI) < 35 kg/m²
- Ability and willingness to perform blood glucose and ketone monitoring using the
Sponsor-provided combined glucose and ketone meter and patient diary at home
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Minimum age
18
Years
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Maximum age
75
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
- Diabetes other than Type 1
- Total daily dose of insulin greater than 90 U/day
- Using an insulin pump requiring pre-filled cartridges
- History of infection at infusion site requiring a drainage in the last 3 months
- History of severe episodes of ketosis requiring hospitalization in the last 6 months
- Active proliferative retinopathy, as defined by a photocoagulation or vitrectomy
occurrence in the 6 months prior to visit 1, or any other unstable (rapidly
progressing) retinopathy that may require photocoagulation or surgical treatment
during the study. An ophthalmoscopic examination should have been performed in the 2
years prior to study entry
- Pregnancy (women of childbearing potential must have a negative pregnancy test at
study entry and a medically approved contraception method) or breastfeeding
- Treatment with systemic corticosteroids or medication known to influence insulin
sensitivity in the 3 months prior to visit 1
- Treatment with antidiabetic drug other than insulin in the 3 months prior to visit 1
- Likelihood of requiring treatments during the study which are not permitted
- Treatment with an investigational product in the 30 days prior to visit 1
- History of sensitivity to the study drugs or to drugs with a similar chemical
structure
- Presence of any condition (medical, including clinically significant abnormal
laboratory test, psychological, social or geographical) actual or anticipated that the
Investigator feels would compromise the patient safety or limit his/her successful
participation in the study
- Night shift workers
- Impaired renal function as shown by serum creatinine =1.5 mg/dL (133 µmol/L) or =1.4
mg/dL (124 µmol/L) in men and women, respectively
- Impaired hepatic function as shown by Alanine aminotransferase (ALT) and/or Aspart
aminotransferase (AST) greater than three times the upper limit of normal range)
- Alcohol or drug abuse in the last year
- Mental condition rendering the patient unable to understand the nature, scope and
possible consequences of the study
The above information is not intended to contain all considerations relevant to a patient's
potential participation in a clinical trial.
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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
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Crossover
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Other design features
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Phase
Phase 4
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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
1/01/2008
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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
1/06/2009
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Sample size
Target
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Accrual to date
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Final
289
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Sanofi-Aventis Administrative Office - Macquarie Park
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Recruitment postcode(s) [1]
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- Macquarie Park
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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New Jersey
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Country [2]
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Austria
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State/province [2]
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Vienna
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Country [3]
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France
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State/province [3]
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Paris
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Country [4]
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Hungary
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State/province [4]
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Budapest
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Country [5]
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Israel
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State/province [5]
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Natanya
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Country [6]
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Italy
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State/province [6]
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Milan
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Country [7]
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Korea, Republic of
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State/province [7]
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Seoul
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Country [8]
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Netherlands
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State/province [8]
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PE Gouda
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Country [9]
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Spain
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State/province [9]
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Barcelona
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Country [10]
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Sweden
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State/province [10]
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Bromma
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Country [11]
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United Kingdom
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State/province [11]
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Guildford Surrey
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Sanofi
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
Primary objective: To demonstrate the superiority of insulin glulisine over insulin aspart
and insulin lispro administered by external pump in term of unexplained hyperglycemia and/or
infusion set occlusion.
Main Secondary objectives:
To compare insulin glulisine, insulin aspart and insulin lispro on:
- Unexplained hyperglycemia
- Infusion set occlusion
- Hypoglycemic episodes,7-point blood glucose profiles
- Episodes of significant ketosis and/or risk level for impending diabetic ketoacidosis
- Time to change the infusion set
- HbA1c (Glycosylated hemoglobin)
- Overall safety: incidence of adverse events
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00607087
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Medical Affairs
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Address
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Sanofi
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00607087
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