PPAR - Combination With Metformin - Full Text View

Sponsored by:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00162240

Purpose

A Phase 3, Randomized, Double-blind, Placebo Controlled, Multicenter Trial to Evaluate the Safety and Efficacy of BMS-298585 in Combination with Metformin Therapy in Subjects with Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Therapy Alone

Condition	Intervention	Phase
Diabetes Mellitus	Drug: Muraglitazar	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Phase 3, Randomized, Double-Blind, Placebo Controlled, Multicenter Trial to Evaluate the Safety and Efficacy of BMS-298585 in Combination With Metformin Therapy in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Therapy Alone

Resource links provided by NLM:

MedlinePlus related topics: Diabetes

Drug Information available for: Muraglitazar Metformin Metformin hydrochloride

U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

compare change from baseline in HbA1c after 24 weeks of treatment with muraglitazar + metformin vs placebo + metformin

Secondary Outcome Measures:

change in FPG from basline to W24, proportion of subjects receiving therapeutic response at W24, percent change of fasting lipid levels from baseline to W11/12, change in hs-CRP from baseline to W24

Estimated Enrollment:	534
Study Start Date:	June 2003

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Type 2 Diabetes
HbA1c > - 7.0% and < - 10.0 %
Mean serum triglyceride < - 600 mg/dL
Body mass index < - 41 kg/m2
Fasting c-peptide > - 1.0 ng/mL

Exclusion Criteria:

History of myocardial infarction (MI)
coronary angioplasty or bypass graft(s)
valvular disease or repair
unstable angina pectoris
transient ischemic attack (TIA), cerebrovascular attack, or cerebrovascular accident (CVA) within 6 months
Congestive heart failure NYHA Class III 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00162240

Show 203 Study Locations

Sponsors and Collaborators

Bristol-Myers Squibb

More Information

Additional Information:

BMS Clinical Trials Disclosure This link exits the ClinicalTrials.gov site

For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CV168-022
Study First Received:	September 9, 2005
Last Updated:	September 27, 2007
ClinicalTrials.gov Identifier:	NCT00162240 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:

Metabolics Diabetes New Onset

Study placed in the following topic categories:

Hypoglycemic Agents
Metabolic Diseases
Metformin
Diabetes Mellitus, Type 2
Diabetes Mellitus

Endocrine System Diseases
Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder

Additional relevant MeSH terms:

Hypoglycemic Agents
Metabolic Diseases
Physiological Effects of Drugs
Metformin

Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 11, 2009