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| Sponsor: | Amylin Pharmaceuticals, Inc. |
|---|---|
| Collaborator: |
Eli Lilly and Company |
| Information provided by: | Amylin Pharmaceuticals, Inc. |
| ClinicalTrials.gov Identifier: | NCT00641056 |
Purpose
The purpose of this study is to compare the effects of 2.0 mg exenatide once weekly and insulin glargine, titrated to glucose targets using the algorithm described by Yki- Järvinen et al.(2007), with respect to glycemic improvements (HbA1c, fasting and postprandial glucose), body weight, lipids, safety and tolerability (including hypoglycemia and anti-exenatide antibodies), and patient reported outcomes.
| Condition | Intervention | Phase |
|---|---|---|
|
Type 2 Diabetes Mellitus |
Drug: Exenatide Once Weekly Drug: Insulin Glargine |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Efficacy of Once-Weekly Exenatide Long-Acting Release and Once-Daily Insulin Glargine in Patients With Type 2 Diabetes Treated With Metformin Alone or in Combination With Sulfonylurea |
| Estimated Enrollment: | 456 |
| Study Start Date: | April 2008 |
| Study Completion Date: | November 2009 |
| Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: Exenatide Once Weekly
subcutaneous injection, 2.0mcg, once weekly
|
| Active Comparator: 2 |
Drug: Insulin Glargine
subcutaneous injection, variable dose, QD
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Have been treated for longer than 2 weeks with any of the following excluded medications within 3 months prior to screening:
Contacts and Locations
Show 75 Study Locations| Study Director: | Chief Medical Officer, MD | Eli Lilly and Company |
More Information
| Responsible Party: | Chief Medical Officer, MD Study Director, Eli Lilly and Company |
| ClinicalTrials.gov Identifier: | NCT00641056 History of Changes |
| Other Study ID Numbers: | H8O-MC-GWBR (DURATION - 3) |
| Study First Received: | March 17, 2008 |
| Last Updated: | June 17, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
diabetes exenatide exenatide once weekly metformin |
sulfonylurea insulin glargine Amylin Lilly |
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Exenatide Glargine |
Insulin Metformin Insulin, Long-Acting Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |