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| Name | Class |
|---|---|
| Eli Lilly and Company | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| exenatide | Experimental | 55 subjects |
|
| Placebo | Placebo Comparator | 55 subjects |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exenatide | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline to 6 months of centrally measured HbA1c | baseline to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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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 :
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michael Joubert, MD | Contact | joubert-m@chu-caen.fr | ||
| Yves Reznik, MD | Contact | reznik-y@chu-caen.fr |
| Name | Affiliation | Role |
|---|---|---|
| Michael JOUBERT, MD | Endocrinology Unit, University Hospital of Caen, FRANCE | Principal Investigator |
| Yves REZNIK, MD | Endocrinology Unit, University Hospital of Caen, FRANCE | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Endocrinology Unit and Clinical Research Center Basse Normandie, University Hospital of Caen | Recruiting | Caen | 14000 | France |
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|
| Placebo | Drug | Placebo |
|
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).
| baseline to 6 months |
| CERIDT | Recruiting | Corbeil-Essonne | France |
|
| Endocrinology Unit | Not yet recruiting | Strasbourg | France |
|
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000077270 | Exenatide |
| ID | Term |
|---|---|
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D014688 | Venoms |
| D045424 | Complex Mixtures |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |
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