Effects of Exenatide on Glycemic Control and Weight in Continuous Subcutaneous Insulin Infusion (CSII) Type 2 Treated Patients With Type 2 Diabetes (EXEPUMP)
This study is currently recruiting participants.
Verified March 2012 by University Hospital, Caen
Sponsor:
University Hospital, Caen
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
University Hospital, Caen
ClinicalTrials.gov Identifier:
NCT01140893
First received: May 3, 2010
Last updated: March 13, 2012
Last verified: March 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Type 2 Diabetes |
Drug: Exenatide Drug: Placebo |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| 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. |
Resource links provided by NLM:
Further study details as provided by University Hospital, Caen:
Primary Outcome Measures:
- Change from baseline to 6 months of centrally measured HbA1c [ Time Frame: baseline to 6 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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).
| Estimated Enrollment: | 110 |
| Study Start Date: | November 2010 |
| Estimated Primary Completion Date: | May 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: exenatide
55 subjects
|
Drug: Exenatide
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
55 subjects
|
Drug: Placebo
Placebo
|
Eligibility| Ages Eligible for Study: | 35 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01140893
Contacts
| Contact: Michael Joubert, MD | joubert-m@chu-caen.fr | |
| Contact: Yves Reznik, MD | reznik-y@chu-caen.fr |
Locations
| France | |
| 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 | |
| CERIDT | Recruiting |
| Corbeil-Essonne, France | |
| Contact: Guillaume Charpentier, MD | |
| Endocrinology Unit | Not yet recruiting |
| Strasbourg, France | |
| Contact: Nathalie Jeandidier, MD, PhD | |
Sponsors and Collaborators
University Hospital, Caen
Eli Lilly and Company
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 |
More Information
No publications provided
| Responsible Party: | University Hospital, Caen |
| ClinicalTrials.gov Identifier: | NCT01140893 History of Changes |
| Other Study ID Numbers: | EudraCT N° 2009-016384-11 |
| Study First Received: | May 3, 2010 |
| Last Updated: | March 13, 2012 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by University Hospital, Caen:
|
Type 2 diabetes CSII Exenatide Double Blind Placebo Controlled Study |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
Exenatide Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013