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

May 3, 2010
January 28, 2014
November 2010
May 2014   (final data collection date for primary outcome measure)
Change from baseline to 6 months of centrally measured HbA1c [ Time Frame: baseline to 6 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01140893 on ClinicalTrials.gov Archive Site
  • 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).
Same as current
Not Provided
Not Provided
 
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.

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.

Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Type 2 Diabetes
  • 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)
  • Drug: Placebo
    Placebo
  • Experimental: exenatide
    55 subjects
    Intervention: Drug: Exenatide
  • Placebo Comparator: Placebo
    55 subjects
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
110
Not Provided
May 2014   (final data collection date for primary outcome measure)

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
Both
35 Years to 70 Years
No
Contact: Michael Joubert, MD joubert-m@chu-caen.fr
Contact: Yves Reznik, MD reznik-y@chu-caen.fr
France
 
NCT01140893
EudraCT N° 2009-016384-11
Yes
University Hospital, Caen
University Hospital, Caen
Eli Lilly and Company
Principal Investigator: Michael JOUBERT, MD Endocrinology Unit, University Hospital of Caen, FRANCE
Principal Investigator: Yves REZNIK, MD Endocrinology Unit, University Hospital of Caen, FRANCE
University Hospital, Caen
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP