Effects of Exenatide on Glycemic Control and Weight in Continuous Subcutaneous Insulin Infusion (CSII) Type 2 Treated Patients With Type 2 Diabetes (EXEPUMP)
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|ClinicalTrials.gov Identifier: NCT01140893|
Recruitment Status : Unknown
Verified July 2016 by University Hospital, Caen.
Recruitment status was: Recruiting
First Posted : June 10, 2010
Last Update Posted : August 23, 2016
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes||Drug: Exenatide Drug: Placebo||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||110 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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.|
|Study Start Date :||November 2010|
|Estimated Primary Completion Date :||May 2017|
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
- Change from baseline to 6 months of centrally measured HbA1c [ Time Frame: baseline to 6 months ]
- 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 ]
- Change from baseline in mean blood glucose value [ Time Frame: baseline to 6 months ]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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01140893
|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|