Efficacy and Safety Study of Rosiglitazone/Metformin Therapy vs Rosiglitazone and Metformin in Type 2 Diabetes Subjects
| Status: | Completed |
|---|---|
| Conditions: | Diabetes, Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - 70 |
| Updated: | 4/17/2018 |
| Start Date: | October 8, 2003 |
| End Date: | December 16, 2004 |
A Randomized, Double-blind Trial to Evaluate the Efficacy and Safety of Fixed Dose Rosiglitazone/Metformin Combination Therapy Compared to Both Rosiglitazone and Metformin Monotherapies in Drug Naive Type 2 Diabetes Mellitus Subjects
The purpose of this 32 week study is to demonstrate that fixed-dose combination treatment
with rosiglitazone/metformin will safely and effectively control glycemia as first line oral
therapy in subjects type 2 diabetes. The primary objective of the study is to demonstrate
superiority of rosiglitazone/metformin compared to its rosiglitazone and metformin.
with rosiglitazone/metformin will safely and effectively control glycemia as first line oral
therapy in subjects type 2 diabetes. The primary objective of the study is to demonstrate
superiority of rosiglitazone/metformin compared to its rosiglitazone and metformin.
Inclusion Criteria:
- 18 to 70 years of age
- Clinical diagnosis of type 2 diabetes
- HbA1c >7.5% to 11%
- FPG <270mg/dL (15mmol)
- Current treatment with diet and/or exercise alone, or no more than 15 days of an
anti-diabetic medication or insulin within 12 weeks of screening
Exclusion Criteria:
- Clinically significant renal or hepatic disease
- Presence of anemia
- Presence of unstable or severe angina, coronary insufficiency, or any congestive heart
failure requiring therapy
- Systolic blood pressure >170mmHg or diastolic blood pressure >100mmHg, while on
anti-hypertensive treatment
- Chronic disease requiring intermittent or chronic treatment with corticosteroids
- Any female lactating, pregnant, or planning to become pregnant
- History of hepatocellular reaction, severe edema or a medically serious fluid related
event associated with any thiazolidinedione
- Presence of acute or chronic metabolic acidosis
- History of diabetic ketoacidosis
We found this trial at
45
sites
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials