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| Sponsor: | Amylin Pharmaceuticals, Inc. |
|---|---|
| Collaborator: |
Eli Lilly and Company |
| Information provided by: | Amylin Pharmaceuticals, Inc. |
| ClinicalTrials.gov Identifier: | NCT00099320 |
Purpose
This study is designed to compare the effects of twice-daily exenatide plus oral antidiabetic (OAD) agents and twice-daily placebo plus OAD with respect to glycemic control, as measured by hemoglobin A1c (HbA1c), in patients with type 2 diabetes who experience inadequate glycemic control with OAD alone.
| Condition | Intervention | Phase |
|---|---|---|
|
Type 2 Diabetes Mellitus |
Drug: exenatide |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Safety and Efficacy of Exenatide in Patients With Type 2 Diabetes Using Thiazolidinediones or Thiazolidinediones and Metformin |
| Estimated Enrollment: | 280 |
| Study Start Date: | May 2004 |
Eligibility| Ages Eligible for Study: | 21 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Show 51 Study Locations| Study Director: | James Malone, MD | Eli Lilly and Company |
More Information
| Study ID Numbers: | H8O-MC-GWAP |
| Study First Received: | December 10, 2004 |
| Last Updated: | November 5, 2007 |
| ClinicalTrials.gov Identifier: | NCT00099320 History of Changes |
| Health Authority: | United States: Food and Drug Administration; Canada: Health Canada; Spain: Spanish Agency of Medicines |
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exenatide exendin-4 diabetes Amylin Lilly |
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Hypoglycemic Agents Metabolic Diseases Exenatide Physiological Effects of Drugs Diabetes Mellitus, Type 2 |
Diabetes Mellitus 2,4-thiazolidinedione Endocrine System Diseases Glucose Metabolism Disorders Pharmacologic Actions |