Study of Muraglitazar Versus Pioglitazone in Type 2 Diabetes

A Phase 3, Randomized, Double-blind, Active Controlled, Multicenter Trial to Evaluate the Safety and Efficacy of Muraglitazar (BMS-298585) Compared to Pioglitazone in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00106808

Enrollment

1440

Registered

2005-04-01

Start date

2005-08-31

Completion date

2006-08-31

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

Type 2 Diabetes Mellitus

Keywords

Type 2 Diabetes

Brief summary

The purpose of this study is to compare Muraglitazar and Pioglitazone in patients with Type 2 Diabetes. Both the safety and blood sugar lowering effects of these treatments will be studied.

Interventions

DRUGMuraglitazar

DRUGPioglitazone

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 * HbA1c \> = 8.0% and \< = 12.0% * Serum triglyceride concentration \< = 600 mg/dL * Fasting c-peptide \> = 1.0 ng/ml * Body mass index \< = 41 kg/m2 * Drug naive patients

Exclusion criteria

* History of MI (myocardial infarction), coronary angioplasty or bypass graft(s), valvular disease or repair, unstable angina pectoris, transient ischemic attack (TIA), cerebrovascular accidents, accelerated/malignant hypertension, or hypertension related CHF (congestive heart failure) within six months prior to screening and during the Lead-In Phase. * Women of child Bearing Potential * Uncontrolled hypertension, CHF defined as New York Heart Association (NYHA) Class II, III and IV, exacerbation of previously stable CHF (any NYHA class) or uncontrolled cardiac arrhythmia in the 30 days prior to screening and during the Lead-In Phase. * History of renal disease, bladder cancer, pulmonary disease, gastrointestinal disease, active liver disease or endocrine disease.

Design outcomes

Primary

Measure	Time frame
Change in HBA1c from baseline to Week 24	—

Secondary

Measure	Time frame
Change for baseline in TG and HDL-C at Week 24	—
Change from baseline in FPG, fasting insulin, fasting c-peptide, body mass index, body weight, waist circumferance, SBP and DBP.	—
To assess safety and tolerability of both Muraglitazar regimens relative to pioglitazone regimen when administered for up to 24 weeks	—

Countries

Argentina, Australia, Brazil, Canada, Chile, India, Mexico, Peru, Philippines, Russia, Taiwan, Thailand, Ukraine, United States

Outcome results

None listed

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