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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: | NCT00729326 |
This study is designed to compare the short-term effects and mechanisms of action of exenatide with those of sitagliptin when either is added to an oral agent(metformin or a thiazolidinedione [TZD]) in adult patients with type 2 diabetes mellitus(T2DM) with inadequate glycemic control.
Condition | Intervention | Phase |
---|---|---|
Type 2 Diabetes Mellitus |
Drug: exenatide Drug: sitagliptin Drug: placebo |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Crossover Assignment, Pharmacokinetics/Dynamics Study |
Official Title: | Comparison of the Effect of Exenatide vs. Sitagliptin on 24-Hour Average Glucose in Patients With Type 2 Diabetes on Metformin or a Thiazolidinedione |
Estimated Enrollment: | 64 |
Study Start Date: | August 2008 |
Estimated Study Completion Date: | October 2009 |
Estimated Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Sequence A: Experimental |
Drug: exenatide
subcutaneous injection (5mcg or 10mcg), twice a day
Drug: sitagliptin
oral administration (100mg), once a day in the morning
Drug: placebo
subcutaneous injection (5mcg or 10mcg), twice a day
Drug: placebo
oral administration (100mg), once a day in the morning
|
Sequence B: Experimental |
Drug: exenatide
subcutaneous injection (5mcg or 10mcg), twice a day
Drug: sitagliptin
oral administration (100mg), once a day in the morning
Drug: placebo
subcutaneous injection (5mcg or 10mcg), twice a day
Drug: placebo
oral administration (100mg), once a day in the morning
|
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Female patients of childbearing potential (not surgically sterilized and between menarche and 1 year postmenopause) who meet any of the following criteria:
Treated with any of the following medications:
Contact: Lilly Clinical Trials Support Center | 1-877-CTLILLY(1-877-285-4559) |
United States, Texas | |
Research Site | |
San Antonio, Texas, United States |
Study Director: | James Malone, MD | Eli Lilly and Company |
Responsible Party: | Eli Lilly and Company ( James Malone, MD, Study Director ) |
Study ID Numbers: | H8O-US-GWCV |
Study First Received: | August 4, 2008 |
Last Updated: | August 7, 2008 |
ClinicalTrials.gov Identifier: | NCT00729326 |
Health Authority: | United States: Institutional Review Board |
diabetes exenatide sitagliptin Amylin |
Lilly metformin thiazolidinedione |
Metabolic Diseases 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 |