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. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Exenatide
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on September 30, 2014