Type 2 Diabetes
Conditions
Keywords
Type 2 diabetes, CSII, Exenatide, Double Blind Placebo Controlled Study
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.
Interventions
DRUGExenatide
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.
DRUGPlacebo
Placebo
Sponsors
Eli Lilly and Company
University Hospital, Caen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
35 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline to 6 months of centrally measured HbA1c | baseline to 6 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | baseline to 6 months | — |
| Change from baseline in mean blood glucose value | baseline to 6 months | 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). |
Countries
France
Contacts
Primary ContactMichael Joubert, MD
Backup ContactYves Reznik, MD
Outcome results
None listed