Effects of EXEnatide on Glycemic Control and Weight over 26 weeks in Continuous Subcutaneous Insulin Infusion (CSII) Treated Patients with Type 2 Diabetes :a phase 2/3 doUble blind randoMized Placebo-controlled trial. - EXEPUMP

• Conditions: Type 2 diabetes mellitus; MedDRA version: 12.0Level: LLTClassification code 10067585Term: Type 2 diabetes mellitus

• Registration Number: EUCTR2009-016384-11-FR
• Lead Sponsor: CHU Caen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01-14
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: Not specified

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified