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

Primary Purpose

Type 2 Diabetes

Status
Unknown status
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Exenatide
Placebo
Sponsored by
University Hospital, Caen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes focused on measuring Type 2 diabetes, CSII, Exenatide, Double Blind Placebo Controlled Study

Eligibility Criteria

35 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Endocrinology Unit and Clinical Research Center Basse Normandie, University Hospital of CaenRecruiting
  • CERIDTRecruiting
  • Endocrinology Unit

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

exenatide

Placebo

Arm Description

55 subjects

55 subjects

Outcomes

Primary Outcome Measures

Change from baseline to 6 months of centrally measured HbA1c

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
Change from baseline in mean blood glucose value
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).

Full Information

First Posted
May 3, 2010
Last Updated
August 22, 2016
Sponsor
University Hospital, Caen
Collaborators
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT01140893
Brief Title
Effects of Exenatide on Glycemic Control and Weight in Continuous Subcutaneous Insulin Infusion (CSII) Type 2 Treated Patients With Type 2 Diabetes
Acronym
EXEPUMP
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.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Unknown status
Study Start Date
November 2010 (undefined)
Primary Completion Date
May 2017 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Caen
Collaborators
Eli Lilly and Company

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
Keywords
Type 2 diabetes, CSII, Exenatide, Double Blind Placebo Controlled Study

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
110 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
exenatide
Arm Type
Experimental
Arm Description
55 subjects
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
55 subjects
Intervention Type
Drug
Intervention Name(s)
Exenatide
Other Intervention Name(s)
Exenatide = BYETTA (R)
Intervention 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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Change from baseline to 6 months of centrally measured HbA1c
Time Frame
baseline to 6 months
Secondary Outcome Measure Information:
Title
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
Title
Change from baseline in mean blood glucose value
Description
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).
Time Frame
baseline to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michael Joubert, MD
Email
joubert-m@chu-caen.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Yves Reznik, MD
Email
reznik-y@chu-caen.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael JOUBERT, MD
Organizational Affiliation
Endocrinology Unit, University Hospital of Caen, FRANCE
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yves REZNIK, MD
Organizational Affiliation
Endocrinology Unit, University Hospital of Caen, FRANCE
Official's Role
Principal Investigator
Facility Information:
Facility Name
Endocrinology Unit and Clinical Research Center Basse Normandie, University Hospital of Caen
City
Caen
ZIP/Postal Code
14000
Country
France
Individual Site Status
Recruiting
Facility Contact:
Phone
+33 2 31 06 45 75
First Name & Middle Initial & Last Name & Degree
Michael JOUBERT, MD
First Name & Middle Initial & Last Name & Degree
Yves REZNIK, MD
Facility Name
CERIDT
City
Corbeil-Essonne
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guillaume Charpentier, MD
Facility Name
Endocrinology Unit
City
Strasbourg
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nathalie Jeandidier, MD, PhD

12. IPD Sharing Statement

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

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