BRL49653C In Type 2 Diabetes -Comparison Study With Pioglitazone And Placebo By Monotherapy-

Clinical Evaluation of Rosiglitazone Malate (BRL49653C) in Patients With Type 2 Diabetes Mellitus (Monotherapy) - Double-Blind Comparative Study of Rosiglitazone Maleate vs. Pioglitazone Hydrochloride and Placebo -

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00297063

Enrollment

350

Registered

2006-02-27

Start date

2006-01-11

Completion date

2007-05-31

Last updated

2022-11-18

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

rosiglitazone, vandia, Type 2 diabetes mellitus, diabetes;

Brief summary

This study is designed to compare the efficacy and safety of BRL49653C versus pioglitazone and placebo.

Interventions

DRUGRosiglitazone

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Eligibility

Sex/Gender

ALL

Age

20 Years to 75 Years

Healthy volunteers

Inclusion criteria

* Type 2 diabetes mellitus. * Managed by diet therapy. * Must have adequate blood, liver and kidney function.

Exclusion criteria

* Serious cardiovascular disease or serious hepatic disease.

Design outcomes

Primary

Measure	Time frame
HbA1c change from baseline at Week 28.	28 Weeks

Secondary

Measure	Time frame
Efficacy variables (changes from baseline in FPG, fasting insulin, HOMA-IR and HOMA-beta) at stipulated date in each treatment group.	28 Weeks

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 26, 2026