Effects of Exenatide on Glycemic Control and Weight in Continuous Subcutaneous Insulin Infusion (CSII) Type 2 Treated Patients With Type 2 Diabetes

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether exenatide is effective to improve glycemic control among type 2 diabetic patients treated by insulin pump therapy.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Caen
• Collaborator: Eli Lilly and Company
• Treatments: Exenatide

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 mellitus

• CSII 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 ≤ 45

• Stable body weight (≤10% variation) during the 3 last months

Exclusion Criteria:

• Type 1 diabetes assessed by positive anti-GAD65 or anti-insulin or anti-IA2 antibodies

• Monogenic 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, rimonabant 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 period

• Clinically significant hepatic disease

• Documented 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/breastfeeding

• Any social and/or mental condition rendering the subject unable to understand the scope and possible consequences of the study

• Concurrent enrolment in another clinical trial

• Geographically inaccessible for follow-up visits required by protocol