Type 2 diabetes mellitus MedDRA version: 12.0 Level: LLT Classification code 10067585 Term: Type 2 diabetes mellitus
Conditions
Interventions
Trade Name: BYETTA
Pharmaceutical Form: Solution for injection
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use
Sponsors
CHU Caen
Eligibility
Inclusion criteria
Inclusion criteria: Men or women aged 35 to 70 Type 2 diabetes diagnosed for at least 12 months, according the criteria of the American Diabetes Association :presence of classic symptoms of diabetes mellitus with unequivocal elevation of plasma glucose (2-hour post-prandial or random glucose >200 mg/dL) or fasting plasma glucose elevation on more than 1 occasion > 125 mg/dL or patient currently undergoing pharmacological and/or non-pharmacological treatment for diabetes mellitusCSII treatment using a rapid analog for at least 6 month (CSII being initiated in patients with HbA1c > 8 % despite a well-conducted MDI trial using a 2 to 5 daily injection regimen)HbA1c = 7,5% and = 10 %BMI = 25 and = 45Stable body weight (=10% variation) during the last 3 months. Are the trial subjects under 18? Number of subjects for this age range: F.1.2 Adults (18-64 years) F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Type 1 diabetes assessed by positive anti-GAD65 or anti-insulin or anti-IA2 antibodiesMonogenic diabetes (MODY, mitochondrial diabetes…)Current treatment with OHA (OHA ought to be interrupted at least two months prior to inclusion in the study)Current treatment specifically addressed for weight lost (orlistat, sibutramine may be interrupted at least 3 months prior to inclusion in the study)Use of corticosteroid therapy for more than 10 days within the 3-past months, or patient who ought to be treated by corticosteroid during the study periodClinically significant hepatic diseaseHistory of confirmed pancreatitisKnown active proliferative retinopathyDocumented gastroparesis, or current use of drugs that directly affect gastrointestinal motility, or any significant abdominal disease that may increase the risk of adverse gastrointestinal effects induced by exenatide Kidney failure (MDRD less than 50 ml/min)Pregnancy/breastfeedingSubject unable to perform twice a day auto-injections of the study drugAny social and/or mental condition rendering the subject unable to understand the scope and possible consequences of the studyConcurrent enrolment in another clinical trialGeographically inaccessible for follow-up visits required by protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Change from baseline to 6 months of centrally measured HbA1c;Secondary Objective: Change from baseline in weight, BMI, waist circumference, 6 points glucose profile, insulin doses, % of daily use of insulin as basal rate, % of daily use of insulin as bolus, quality of life questionnaire.In addition, secondary endpoints based on CGMS recordings performed in centers participating to the ancillary study : Change from baseline in mean blood glucose value, occurrence of hyperglycemia above 190 mg/dl expressed as Area under the Curve (high) above 190 mg/dl (10.5 mmol/l), occurrence of hypoglycemia below 70 mg/dl (3.9 mmol/l) expressed as Area Under the Curve (low) below 70 mg/dl, glycemic variability (MAGE index);Primary end point(s): The primary objective is to estimate the difference in change in HbA1c from baseline to treatment endpoint (26 weeks) between exenatide versus placebo in type 2 diabetes patients uncontrolled by CSII (HbA1c between 7.5 to 10%). | — |
Countries
France
Outcome results
None listed