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

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.

Sponsors

Lead Sponsor: University Hospital, Caen

Collaborator: Eli Lilly and Company

Source University Hospital, Caen
Brief 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.

Overall Status Unknown status
Start Date November 2010
Primary Completion Date May 2017
Phase Phase 2/Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Change from baseline to 6 months of centrally measured HbA1c baseline to 6 months
Secondary Outcome
Measure 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 baseline to 6 months
Change from baseline in mean blood glucose value baseline to 6 months
Enrollment 110
Condition
Intervention

Intervention Type: Drug

Intervention Name: Exenatide

Description: 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.

Arm Group Label: exenatide

Other Name: Exenatide = BYETTA (R)

Intervention Type: Drug

Intervention Name: Placebo

Description: Placebo

Arm Group Label: Placebo

Eligibility

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

Gender: All

Minimum Age: 35 Years

Maximum Age: 70 Years

Healthy Volunteers: No

Overall Official
Overall Contact

Last Name: Michael Joubert, MD

Email: [email protected]

Location
Facility: Status: Contact: Investigator:
Endocrinology Unit and Clinical Research Center Basse Normandie, University Hospital of Caen | Caen, 14000, France Recruiting +33 2 31 06 45 75 Michael JOUBERT, MD Principal Investigator Yves REZNIK, MD Principal Investigator
CERIDT | Corbeil-Essonne, France Recruiting Guillaume Charpentier, MD
Endocrinology Unit | Strasbourg, France Not yet recruiting Nathalie Jeandidier, MD, PhD
Location Countries

France

Verification Date

July 2016

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: exenatide

Type: Experimental

Description: 55 subjects

Label: Placebo

Type: Placebo Comparator

Description: 55 subjects

Acronym EXEPUMP
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov