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Sponsors and Collaborators: |
Amylin Pharmaceuticals, Inc. Eli Lilly and Company |
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Information provided by: | Amylin Pharmaceuticals, Inc. |
ClinicalTrials.gov Identifier: | NCT00676338 |
This study will compare the effects of 2.0 mg exenatide once weekly injection as monotherapy to 3 active comparators(metformin, dipeptidyl peptidase-4 inhibitor, and thiazolidinedione) in drugnaive patients with type 2 diabetes treated with diet and exercise.
Condition | Intervention | Phase |
---|---|---|
Type 2 Diabetes Mellitus |
Drug: exenatide once weekly Drug: metformin Drug: sitagliptin Drug: pioglitazone |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study |
Official Title: | Safety and Efficacy of Exenatide Once Weekly Injection Versus Metformin, Dipeptidyl Peptidase-4 Inhibitor, or Thiazolidinedione as Monotherapy in Drug-Naive Patients With Type 2 Diabetes |
Estimated Enrollment: | 822 |
Study Start Date: | October 2008 |
Estimated Study Completion Date: | September 2010 |
Estimated Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: exenatide once weekly
subcutaneuous injection, 2mg, once weekly
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2: Active Comparator |
Drug: metformin
oral, 1000-2500mg, daily
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3: Active Comparator |
Drug: sitagliptin
oral, 100 mg, daily
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4: Active Comparator |
Drug: pioglitazone
oral, 30-45mg, daily
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Lilly Clinical Trials Support Center | 1-877-CTLILLY (1-877-285-4559) |
Study Director: | Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company |
Responsible Party: | Eli Lilly and Company ( Study Director ) |
Study ID Numbers: | H8O-MC-GWCH (DURATION - 4) |
Study First Received: | May 9, 2008 |
Last Updated: | October 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00676338 |
Health Authority: | United States: Food and Drug Administration |
Amylin Lilly exenatide once weekly Byetta |
Januvia sitagliptin thiazolidinedione |
Metabolic Diseases Pioglitazone Exenatide Metformin Diabetes Mellitus, Type 2 Diabetes Mellitus |
2,4-thiazolidinedione Endocrine System Diseases Endocrinopathy Metabolic disorder Glucose Metabolism Disorders Sitagliptin |
Dipeptidyl-Peptidase IV Inhibitors Hypoglycemic Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs |
Enzyme Inhibitors Pharmacologic Actions Protease Inhibitors |