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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: | NCT00765817 |
This study will compare the efficacy and safety of exenatide versus placebo in adults whose diabetes is not fully controlled by insulin glargine with or without metformin and/or pioglitazone.
Condition | Intervention | Phase |
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Type 2 Diabetes |
Drug: placebo Drug: exenatide |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized Trial Comparing Exenatide With Placebo in Subjects With Type 2 Diabetes on Insulin Glargine With or Without Oral Antihyperglycemic Medications |
Estimated Enrollment: | 260 |
Study Start Date: | October 2008 |
Estimated Study Completion Date: | August 2010 |
Estimated Primary Completion Date: | August 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
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2: Experimental |
Drug: exenatide
subcutaneous injection, twice a day, 10mcg
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Have been taking insulin glargine alone or in combination with one of the following for at least 3 months before entering the study:
a combination of metformin and pioglitazone (stable dose for 6 weeks)
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: | H80-US-GWCO |
Study First Received: | October 1, 2008 |
Last Updated: | October 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00765817 |
Health Authority: | United States: Food and Drug Administration; United Kingdom: Medicines and Healthcare Products Regulatory Agency; Greece: Ethics Committee; Mexico: Ethics Committee; Israel: Ministry of Health |
diabetes exenatide Amylin Lilly |
metformin pioglitazone insulin glargine |
Metabolic Diseases Pioglitazone Exenatide Metformin Diabetes Mellitus, Type 2 Glargine |
Diabetes Mellitus Endocrine System Diseases Endocrinopathy Metabolic disorder Glucose Metabolism Disorders Insulin |
Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |