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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00246987
First Posted: November 1, 2005
Last Update Posted: April 27, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Bristol-Myers Squibb
  Purpose
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.

Condition Intervention Phase
Diabetes, Type 2 Drug: Muraglitazar Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

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.

Estimated Enrollment: 341
Study Start Date: June 2003
Study Completion Date: April 2004
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00246987


  Show 130 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
  More Information

Additional Information:
ClinicalTrials.gov Identifier: NCT00246987     History of Changes
Other Study ID Numbers: CV168-018
First Submitted: October 28, 2005
First Posted: November 1, 2005
Last Update Posted: April 27, 2012
Last Verified: April 2012

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases