Diabetes Mellitus, Type 2 Clinical Trial
Official title:
Clinical Evaluation of Rosiglitazone Malate (BRL49653C) in Patients With Type 2 Diabetes Mellitus -Long-term Study of Rosiglitazone Maleate-
| Verified date | October 2016 |
| Source | GlaxoSmithKline |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This study is designed to evaluate the safety of BRL49653C administrated for 52 weeks
| Status | Completed |
| Enrollment | 70 |
| Est. completion date | April 2007 |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 20 Years and older |
| Eligibility |
Inclusion Criteria: - Patients with type 2 diabetes mellitus managed by diet therapy or one antidiabetic agent (sulfonylurea or alpha glucosidase inhibitor) will be candidates for this study. These candidates will be checked up on their clinical laboratory data, and must have adequate blood, liver and kidney function. Exclusion Criteria: - Patient with serious cardiovascular disease or serious hepatic disease will not be eligible. |
| Country | Name | City | State |
|---|---|---|---|
| GSK Investigational Site |
| Lead Sponsor | Collaborator |
|---|---|
| GlaxoSmithKline |
This study has not been published in the scientific literature.
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | The safety profile (adverse events, laboratory parameters and other observations) of BRL49653C administered for 52 weeks will be evaluated. | 52 Weeks | ||
| Secondary | The efficacy profile (HbA1c, FPG and Insulin) of BRL49653C administered for 52 weeks will be evaluated. | 52 Weeks |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
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