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A Trial to Evaluate BMS-298585 as Monotherapy in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control

Primary Purpose

Diabetes, Type 2

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

About this trial

This is an interventional treatment trial for Diabetes, Type 2

Eligibility Criteria

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

Inclusion Criteria: Subjects with Type 2 diabetes Drug Naive HbA1c >= 7.0% and <= 10.0% Body Mass Index <= 41 kg/m2 Serum TG <= 600 mg/dL Exclusion Criteria: Symptomatic Type 2 diabetes History of bladder cancer History of Myocardial Infarction (MI), coronary angioplasty or bypass grafts, valvular disease or repair, unstable angina pectoris, Transient Ischemic Attach (TIA), or Cerebrovascular Accident (CVA) within 6 months, congestive heart failure (NYHA Class II and IV), uncontrolled hypertension, history of renal disease, peripheral vascular disease (PVD), 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

Changes achieved from baseline in FPG after 24 weeks. Changes achieved from baseline in 3 hour post-prandial AUC for glucose and insulin levels after 24 weeks vs. placebo.

Full Information

First Posted
October 28, 2005
Last Updated
April 26, 2012
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT00246987
Brief Title
A Trial to Evaluate BMS-298585 as Monotherapy in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control
Official Title
A Phase 3, Randomized, Double-blind, Placebo Controlled, Multicenter Trial to Evaluate the Safety and Efficacy of BMS-298585 as Monotherapy in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control
Study Type
Interventional

2. Study Status

Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
June 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2004 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Bristol-Myers Squibb

4. Oversight

5. Study Description

Brief Summary
To determine the effect on glycemic control and lipid parameters of the 2.5 and 5 mg. doses of BMS-298585 in drug naive subjects with Type 2 diabetes as an adjunct to diet and exercise.

6. Conditions and Keywords

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

7. Study Design

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

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Muraglitazar
Primary Outcome Measure Information:
Title
Change in HbA1c from baseline to Week 24
Secondary Outcome Measure Information:
Title
Changes achieved from baseline in FPG after 24 weeks. Changes achieved from baseline in 3 hour post-prandial AUC for glucose and insulin levels after 24 weeks vs. placebo.

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: Subjects with Type 2 diabetes Drug Naive HbA1c >= 7.0% and <= 10.0% Body Mass Index <= 41 kg/m2 Serum TG <= 600 mg/dL Exclusion Criteria: Symptomatic Type 2 diabetes History of bladder cancer History of Myocardial Infarction (MI), coronary angioplasty or bypass grafts, valvular disease or repair, unstable angina pectoris, Transient Ischemic Attach (TIA), or Cerebrovascular Accident (CVA) within 6 months, congestive heart failure (NYHA Class II and IV), uncontrolled hypertension, history of renal disease, peripheral vascular disease (PVD), pulmonary disease, gastrointestinal disease, active liver disease or endocrine disease.
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Anniston
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United States
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Birmingham
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Golden
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Markham
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Oakville
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Ottawa
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Thornhill
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Thunder Bay
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Toronto
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Charlottetown
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Chicoutimi
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Drummondville
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Granby
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Laval
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Longueuil
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Montreal
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Pointe-Claire
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Quebec
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St-Lambert
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Quebec
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Canada
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Ste-Foy
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Quebec
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Regina
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Canada
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Saskatoon
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Mexico City
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Distrito Federal
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Mexico
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Cuernavaca
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Morelos
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Mexico
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Aguascalientes
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Mexico
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Durango
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Mexico
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Krakow
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Poland
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Lodz
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Poland
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Mrokow
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Poland
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Warszawa
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Poland
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Zabrze
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Poland
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Anasco
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Puerto Rico
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Ponce
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Puerto Rico
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Rio Pieoras
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Puerto Rico
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Changhua
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Taiwan
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Taichung
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Taiwan

12. IPD Sharing Statement

Learn more about this trial

A Trial to Evaluate BMS-298585 as Monotherapy in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control

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