- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01140893
Effects of Exenatide on Glycemic Control and Weight in Continuous Subcutaneous Insulin Infusion (CSII) Type 2 Treated Patients With Type 2 Diabetes (EXEPUMP)
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 Overview
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Contact
- Name: Michaël JOUBERT, MD
- Email: joubert-m@chu-caen.fr
Study Contact Backup
- Name: Yves Reznik, MD
- Email: reznik-y@chu-caen.fr
Study Locations
-
-
-
Caen, France, 14000
- Recruiting
- Endocrinology Unit and Clinical Research Center Basse Normandie, University Hospital of Caen
-
Contact:
- Phone Number: +33 2 31 06 45 75
-
Principal Investigator:
- Michaël JOUBERT, MD
-
Principal Investigator:
- Yves REZNIK, MD
-
Corbeil-Essonne, France
- Recruiting
- CERIDT
-
Contact:
- Guillaume Charpentier, MD
-
Strasbourg, France
- Not yet recruiting
- Endocrinology Unit
-
Contact:
- Nathalie Jeandidier, MD, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: exenatide
55 subjects
|
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 Names:
|
Placebo Comparator: Placebo
55 subjects
|
Placebo
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change from baseline to 6 months of centrally measured HbA1c
Time Frame: baseline to 6 months
|
baseline to 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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).
|
baseline to 6 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Michael JOUBERT, MD, Endocrinology Unit, University Hospital of Caen, FRANCE
- Principal Investigator: Yves REZNIK, MD, Endocrinology Unit, University Hospital of Caen, FRANCE
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EudraCT N° 2009-016384-11
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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