Informations générales (source: ClinicalTrials.gov)
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. (EXEPUMP)
Interventional
Phase 2/Phase 3
University Hospital, Caen (Voir sur ClinicalTrials)
novembre 2010
29 juin 2024
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.
Etablissements
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| Endocrinology Unit - Strasbourg - France | Nathalie Jeandidier, MD, PhD | Contact (sur clinicalTrials) | |||
| Endocrinology Unit and Clinical Research Center Basse Normandie, University Hospital of Caen - 14000 - Caen - France | Contact (sur clinicalTrials) | ||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| CERIDT - Corbeil-Essonne - France | Guillaume Charpentier, MD | Contact (sur clinicalTrials) | |||
Critères
Tous
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
- 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
- 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