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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: | NCT00701935 |
A multicenter, randomized, double-blind, placebo-controlled trial will assess the effects of twice-daily subcutaneous injection with exenatide versus treatment with matching placebo injection on abdominal visceral fat content.
Condition | Intervention | Phase |
---|---|---|
Diabetes Mellitus |
Drug: placebo Drug: exenatide |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Effect of Exenatide on Abdominal Fat Distribution in Patients With Type 2 Diabetes Pretreated With Metformin |
Estimated Enrollment: | 94 |
Study Start Date: | August 2008 |
Estimated Study Completion Date: | October 2010 |
Estimated Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Placebo Comparator |
Drug: placebo
subcutaneous injection, twice a day, 10mcg
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2: Experimental |
Drug: exenatide
subcutaneous injection, twice a day, 10mcg
|
Ages Eligible for Study: | 18 Years to 85 Years |
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) |
Canada | |
Research Site | Not yet recruiting |
Quebec, Canada | |
Contact: Lilly Clinical Trials Support Center 1-877-CTLILLY (1-877-285-4559) | |
Canada, Alberta | |
Research Site | Recruiting |
Calgary, Alberta, Canada | |
Contact: Lilly Clinical Trials Support Center 1-877-CTLILLY (1-877-285-4559) | |
Canada, British Columbia | |
Research Site | Recruiting |
Vancouver, British Columbia, Canada | |
Contact: Lilly Clinical Trials Support Center 1-877-CTLILLY (1-877-285-4559) | |
Research Site | Recruiting |
Victoria, British Columbia, Canada | |
Contact: Lilly Clinical Trials Support Center 1-877-CTLILLY (1-877-285-4559) | |
Canada, New Brunswick | |
Research Site | Recruiting |
Saint John, New Brunswick, Canada | |
Contact: Lilly Clinical Trials Support Center 1-877-CTLILLY (1-877-285-4559) | |
Canada, Ontario | |
Research Site | Recruiting |
Toronto, Ontario, Canada | |
Contact: Lilly Clinical Trials Support Center 1-877-CTLILLY (1-877-285-4559) | |
Research Site | Recruiting |
Ottawa, Ontario, Canada | |
Contact: Lilly Clinical Trials Support Center 1-877-CTLILLY (1-877-285-4559) | |
Research Site | Recruiting |
London, Ontario, Canada | |
Contact: Lilly Clinical Trials Support Center 1-877-CTLILLY (1-877-285-4559) | |
Canada, Quebec | |
Research Site | Not yet recruiting |
Chicoutimi, Quebec, Canada | |
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-CA-GWCE |
Study First Received: | June 17, 2008 |
Last Updated: | March 30, 2009 |
ClinicalTrials.gov Identifier: | NCT00701935 History of Changes |
Health Authority: | Canada: Health Canada |
diabetes mellitus Amylin Lilly |
Hypoglycemic Agents Metabolic Diseases Exenatide Metformin Amylin Diabetes Mellitus, Type 2 |
Diabetes Mellitus Endocrine System Diseases Endocrinopathy Glucose Metabolism Disorders Metabolic Disorder |
Hypoglycemic Agents Metabolic Diseases Exenatide Physiological Effects of Drugs Diabetes Mellitus, Type 2 |
Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Pharmacologic Actions |