A Study Of BRL49653C For The Treatment Of Type 2 Diabetes

Clinical Evaluation of Rosiglitazone Malate (BRL49653C) in Patients With Type 2 Diabetes Mellitus -Long-term Study of Rosiglitazone Maleate-

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00523913

Enrollment

Registered

2007-09-03

Start date

2005-11-30

Completion date

2007-04-30

Last updated

2016-10-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2

Keywords

type 2 diabetes mellitus;, diabetes;, rosiglitazone, Avandia;

Brief summary

This study is designed to evaluate the safety of BRL49653C administrated for 52 weeks

Interventions

DRUGrosiglitazone

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
The safety profile (adverse events, laboratory parameters and other observations) of BRL49653C administered for 52 weeks will be evaluated.	52 Weeks

Secondary

Measure	Time frame
The efficacy profile (HbA1c, FPG and Insulin) of BRL49653C administered for 52 weeks will be evaluated.	52 Weeks

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 9, 2026