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| Sponsored by: |
GlaxoSmithKline |
|---|---|
| Information provided by: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00067951 |
Purpose
The purpose of this research study is to determine if a new investigational diabetes drug is safe and effective in treating people who have Type II diabetes mellitus with very high HbA1c or FPG (fasting plasma glucose) levels. The HbA1c test, also called the hemoglobin A1c test or glycated hemoglobin test, is a measurement of the average amount of sugar in the blood over the last 2 to 3 months. FPG is a test that measures the amount of sugar in the blood after an 8 hour fast.
| Condition | Intervention | Phase |
|---|---|---|
|
Non-Insulin-Dependent Diabetes Mellitus |
Drug: rosiglitazone/metformin |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | An Open-Label Trial to Evaluate the Safety and Efficacy of Fixed Dose Rosiglitazone/Metformin Combination Therapy in Poorly-Controlled Subjects With Type 2 Diabetes Mellitus |
| Estimated Enrollment: | 190 |
| Study Start Date: | October 2003 |
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Show 68 Study Locations| Study Director: | GSK Clinical Trials, MD, PhD | GlaxoSmithKline |
More Information
| Responsible Party: | GSK ( Study Director ) |
| Study ID Numbers: | 712753/004 |
| Study First Received: | September 3, 2003 |
| Last Updated: | May 15, 2009 |
| ClinicalTrials.gov Identifier: | NCT00067951 History of Changes |
| Health Authority: | United States: Food and Drug Administration; Canada: Health Canada |
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Type 2 diabetes mellitus Hyperglycemia Hemoglobin A1c HbA1c |
|
Hypoglycemic Agents Metabolic Diseases Hyperglycemia Metformin Diabetes Mellitus, Type 2 Diabetes Mellitus |
Endocrine System Diseases Endocrinopathy Glucose Metabolism Disorders Rosiglitazone Metabolic Disorder |
|
Hypoglycemic Agents Metabolic Diseases Physiological Effects of Drugs Metformin Diabetes Mellitus, Type 2 |
Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Rosiglitazone Pharmacologic Actions |