Effects of Exenatide on Glycemic Control and Weight in Continuous Subcutaneous Insulin Infusion (CSII) Type 2 Treated Patients With Type 2 Diabetes (EXEPUMP)
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||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.|
- Change from baseline to 6 months of centrally measured HbA1c [ Time Frame: baseline to 6 months ] [ Designated as safety issue: No ]
- 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 [ Time Frame: baseline to 6 months ] [ Designated as safety issue: No ]
- Change from baseline in mean blood glucose value [ Time Frame: baseline to 6 months ] [ Designated as safety issue: Yes ]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).
|Study Start Date:||November 2010|
|Estimated Primary Completion Date:||May 2014 (Final data collection date for primary outcome measure)|
Research drug (exenatide or placebo), will begin at V0, after randomization. The initial dosage for the first month will be 5 µg SC BID. Injections can be administered at any time within the 60 minute period before the morning and evening meal.
From V1, research drug will be titrated from 5 to 10 µg SC BID. If gastro-intestinal adverse effects occur with 10 µg SC BID, the dosage will be back-titrated to 5 µg SC BID. Thus, the higher research drug dosage tolerated will be used during the study time.
Other Name: Exenatide = BYETTA (R)
Placebo Comparator: Placebo
|Contact: Michael Joubert, MDfirstname.lastname@example.org|
|Contact: Yves Reznik, MDemail@example.com|
|Endocrinology Unit and Clinical Research Center Basse Normandie, University Hospital of Caen||Recruiting|
|Caen, France, 14000|
|Contact +33 2 31 06 45 75|
|Principal Investigator: Michael JOUBERT, MD|
|Principal Investigator: Yves REZNIK, MD|
|Contact: Guillaume Charpentier, MD|
|Endocrinology Unit||Not yet recruiting|
|Contact: Nathalie Jeandidier, MD, PhD|
|Principal Investigator:||Michael JOUBERT, MD||Endocrinology Unit, University Hospital of Caen, FRANCE|
|Principal Investigator:||Yves REZNIK, MD||Endocrinology Unit, University Hospital of Caen, FRANCE|