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

August 22, 2016 updated by: University Hospital, Caen

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.

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

110

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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:
  • Exenatide = BYETTA (R)
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

This is where you will find people and organizations involved with this study.

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2010

Primary Completion (Anticipated)

May 1, 2017

Study Registration Dates

First Submitted

May 3, 2010

First Submitted That Met QC Criteria

June 9, 2010

First Posted (Estimate)

June 10, 2010

Study Record Updates

Last Update Posted (Estimate)

August 23, 2016

Last Update Submitted That Met QC Criteria

August 22, 2016

Last Verified

July 1, 2016

More Information

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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