![]() |
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
Sponsors and Collaborators: |
Amylin Pharmaceuticals, Inc. Eli Lilly and Company |
---|---|
Information provided by: | Amylin Pharmaceuticals, Inc. |
ClinicalTrials.gov Identifier: | NCT00603239 |
This study will assess safety and efficacy of exenatide in combination with a thiazolidinedione (TZD) and a TZD plus metformin over 26 weeks in adult patients with type 2 diabetes who have not achieved adequate glycemic control.
Condition | Intervention | Phase |
---|---|---|
Type 2 Diabetes Mellitus |
Drug: exenatide Drug: placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Safety and Efficacy of Exenatide in Patients With Type 2 Diabetes Using a Thiazolidinedione or a Thiazolidinedione and Metformin |
Estimated Enrollment: | 180 |
Study Start Date: | January 2008 |
Estimated Study Completion Date: | June 2009 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: exenatide
subcutaneous injection, 5mcg or 10mcg, twice a day
|
2: Placebo Comparator |
Drug: placebo
subcutaneous injection, volume equivalent to 5mcg or 10mcg of active drug, twice a day
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Are currently treated with any of the following excluded medications:
Study Director: | James Malone, MD | Eli Lilly and Company |
Responsible Party: | Eli Lilly and Company ( James Malone, MD, Study Director ) |
Study ID Numbers: | H8O-MC-GWCG |
Study First Received: | January 17, 2008 |
Last Updated: | August 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00603239 |
Health Authority: | United States: Food and Drug Administration; Mexico: Ministry of Health; South Africa: Medicines Control Council; Canada: Health Canada; Romania: National Medicines Agency |
diabetes exenatide metformin thiazolidinedione |
Byetta Amylin Lilly |
Metabolic Diseases Exenatide Metformin Diabetes Mellitus, Type 2 Diabetes Mellitus |
2,4-thiazolidinedione Endocrine System Diseases Endocrinopathy Metabolic disorder Glucose Metabolism Disorders |
Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |