| Trial ID: | L6614 |
| Source ID: | NCT01140893
|
| Associated Drug: |
Exenatide
|
| 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
|
| Status: |
UNKNOWN
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes
|
| Interventions: |
DRUG: Exenatide|DRUG: Placebo
|
| Outcome Measures: |
Primary: Change from baseline to 6 months of centrally measured HbA1c, baseline to 6 months | Secondary: 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, 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
|
| Sponsor/Collaborators: |
Sponsor: University Hospital, Caen | Collaborators: Eli Lilly and Company
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2|PHASE3
|
| Enrollment: |
110
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2010-11
|
| Completion Date: |
|
| Results First Posted: |
|
| Last Update Posted: |
2016-08-23
|
| Locations: |
Endocrinology Unit and Clinical Research Center Basse Normandie, University Hospital of Caen, Caen, 14000, France|CERIDT, Corbeil-Essonne, France|Endocrinology Unit, Strasbourg, France
|
| URL: |
https://clinicaltrials.gov/show/NCT01140893
|
