Status:
UNKNOWN
Effects of Exenatide on Glycemic Control and Weight in Continuous Subcutaneous Insulin Infusion (CSII) Type 2 Treated Patients With Type 2 Diabetes
Lead Sponsor:
University Hospital, Caen
Collaborating Sponsors:
Eli Lilly and Company
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
35-70 years
Phase:
PHASE2
PHASE3
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT01140893
Start Date
November 1 2010
Last Update
August 23 2016
Active Locations (3)
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1
Endocrinology Unit and Clinical Research Center Basse Normandie, University Hospital of Caen
Caen, France, 14000
2
CERIDT
Corbeil-Essonne, France
3
Endocrinology Unit
Strasbourg, France