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 January 2014 by University Hospital, Caen
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
University Hospital, Caen
ClinicalTrials.gov Identifier:
NCT01140893
First received: May 3, 2010
Last updated: January 28, 2014
Last verified: January 2014
  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 2014 (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: January 28, 2014
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 April 16, 2014