Metabolics Diabetes Nos
Conditions
Brief summary
A Phase 3, Randomized, Double-blind, Placebo Controlled, Multicenter Trial to Evaluate the Safety and Efficacy of BMS-298585 in Combination with Glyburide Therapy in Subjects with Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Sulfonylurea Therapy Alone.
Interventions
DRUGMuraglitazar
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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 . 1.5 ng/mL.
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 attack, or cerebrovascular accident (CVA) within 6 months, congestive heart failure (NYHA Class III and IV, uncontrolled hypertension, history or renal disease, peripheral vascular disease (PVD), pulmonary disease, gastrointestinal disease, active liver disease or endocrine disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Compare change from baseline in HbA1c after 24 weeks of treatment with muraglitazar + glyburide vs placebo + glyburide | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Argentina, Australia, Brazil, Canada, France, Germany, Italy, Mexico, Netherlands, Peru, Puerto Rico, Russia, Spain, United Kingdom, United States
Outcome results
None listed