Study Comparing Muraglitazar With Glimepiride in Type 2 Diabetics Who Are Not Controlled With Metformin Alone

A Phase 3, Randomized, Three-Arm, Double-blind, Active Controlled, Parallel Group, Multicenter Trial to Evaluate the Safety and Efficacy of Muraglitazar in Combination With Metformin Compared to Glimepiride in Combination With Metformin in Subjects Wtih Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Therapy Alone

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00095030

Enrollment

1752

Registered

2004-11-01

Start date

2004-02-29

Completion date

2006-03-31

Last updated

2010-09-14

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

Diabetes

Brief summary

The purpose of this clinical research study is to learn whether a muraglitazar-metformin combination is at least as effective as a glimepiride-metformin combination to treat type 2 diabetics who are not sufficiently controlled with metformin alone. The safety of this treatment will also be studied.

Interventions

DRUGmuraglitazar

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

* Subject with Type 2 diabetes receiving treatment with at least 1,500 mg but not greater than 3000 mg of stable metformin therapy for at least 6 weeks prior to screening * HbA1c \>or = 7% and \< or = 10% * Fasting c-peptide \> or = 1.0 umol * Body Mass Index \< or = 41 kg/m2 * Mean serum triglycerides \< or = 600 mg/dl

Design outcomes

Primary

Measure	Time frame
Change in baseline HbA1c after 52 weeks	—

Secondary

Measure	Time frame
Change in lipids after 52 weeks; safety and efficacy when administered with metformin after 52 weeks	—

Countries

Argentina, Austria, Brazil, Canada, Chile, Germany, Hong Kong, Mexico, Peru, Philippines, Poland, Puerto Rico, Russia, Switzerland, Taiwan, Thailand, United States

Outcome results

None listed

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