Efficacy and Safety In Poorly Controlled Type 2 Diabetics

A 24-week Randomized, Double-Blind, Parallel-Group, Multicenter Study to Demonstrate the Efficacy and Safety of Two Different Rosiglitazone Dosing Regimens, 4mg OD and 8mg OD, in Poorly-Controlled Drug Naive Patients With Type 2 Diabetes Mellitus

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00044460

Enrollment

142

Registered

2002-08-30

Start date

2002-05-31

Completion date

2003-04-10

Last updated

2017-10-09

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 drug-naive

Brief summary

The purpose of this study is to gain safety and efficacy information in patients with type 2 diabetes, who have not previously taken any oral antidiabetic medications, and who have an HbA1c value of greater than or equal to 10%, despite diet and exercise.

Interventions

DRUGrosiglitazone

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

* Type 2 diabetes * Drug-naive. * Laboratory test result for HbA1c of greater than or equal to 10%. * Written informed consent.

Exclusion criteria

* Prior use of antidiabetic medications within 3 months of screening. * Fluid retention (edema). * Significant liver disease. * Low red blood cells (anemia). * Severe or unstable angina (chest pain). * Congestive heart failure. * Severe high blood pressure. * Alcohol or drug abuse. * Other inclusion or

Design outcomes

Primary

Measure	Time frame
Change in HbA1c from baseline to Week 24.	—

Secondary

Measure	Time frame
Change in FPG (fasting plasma glucose) from baseline to Week 24; characterize the effects of rosiglitazone on the albumin-creatinine ratio at Week 24.	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026