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Study of Muraglitazar Versus Pioglitazone in Type 2 Diabetes

Primary Purpose

Type 2 Diabetes Mellitus

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Muraglitazar
Pioglitazone
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring Type 2 Diabetes

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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.

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Outcomes

Primary Outcome Measures

Change in HBA1c from baseline to Week 24

Secondary Outcome Measures

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

Full Information

First Posted
March 31, 2005
Last Updated
September 10, 2010
Sponsor
Bristol-Myers Squibb
Collaborators
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT00106808
Brief Title
Study of Muraglitazar Versus Pioglitazone in Type 2 Diabetes
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2007
Overall Recruitment Status
Completed
Study Start Date
August 2005 (undefined)
Primary Completion Date
August 2006 (Actual)
Study Completion Date
August 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Bristol-Myers Squibb
Collaborators
Merck Sharp & Dohme LLC

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
Keywords
Type 2 Diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
1440 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Muraglitazar
Intervention Type
Drug
Intervention Name(s)
Pioglitazone
Primary Outcome Measure Information:
Title
Change in HBA1c from baseline to Week 24
Secondary Outcome Measure Information:
Title
Change for baseline in TG and HDL-C at Week 24
Title
Change from baseline in FPG, fasting insulin, fasting c-peptide, body mass index, body weight, waist circumferance, SBP and DBP.
Title
To assess safety and tolerability of both Muraglitazar regimens relative to pioglitazone regimen when administered for up to 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
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Facility Name
Local Institution
City
Lima
Country
Peru
Facility Name
Local Institution
City
Cebu
Country
Philippines
Facility Name
Local Institution
City
Las Pinas
Country
Philippines
Facility Name
Local Institution
City
Manila City
Country
Philippines
Facility Name
Local Institution
City
Manila
Country
Philippines
Facility Name
Local Institution
City
Pasig City
Country
Philippines
Facility Name
Local Institution
City
Quezon City
Country
Philippines
Facility Name
Local Institution
City
Quezon
Country
Philippines
Facility Name
Local Institution
City
Kirov
Country
Russian Federation
Facility Name
Local Institution
City
Moscow
Country
Russian Federation
Facility Name
Local Institution
City
Saratov
Country
Russian Federation
Facility Name
Local Institution
City
St. Petersburg
Country
Russian Federation
Facility Name
Local Institution
City
Yaroslavl
Country
Russian Federation
Facility Name
Local Institution
City
Kaohsiung
Country
Taiwan
Facility Name
Local Institution
City
Taipei
Country
Taiwan
Facility Name
Local Institution
City
Taoyuan Hsien
Country
Taiwan
Facility Name
Local Institution
City
Bangkok
Country
Thailand
Facility Name
Local Institution
City
Kong Kaen
Country
Thailand
Facility Name
Local Institution
City
Songkla
Country
Thailand
Facility Name
Local Institution
City
Taipei City
Country
Thailand
Facility Name
Local Institution
City
Dniepropetrovsk
Country
Ukraine
Facility Name
Local Institution
City
Kharkiv
Country
Ukraine
Facility Name
Local Institution
City
Kiev
Country
Ukraine
Facility Name
Local Institution
City
Kyiv
Country
Ukraine
Facility Name
Local Institution
City
Odessa
Country
Ukraine
Facility Name
Local Institution
City
Simferopol
Country
Ukraine

12. IPD Sharing Statement

Learn more about this trial

Study of Muraglitazar Versus Pioglitazone in Type 2 Diabetes

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