Diabetes Mellitus
Conditions
Keywords
Metabolics Diabetes New Onset
Brief summary
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
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 \> - 1.0 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| compare change from baseline in HbA1c after 24 weeks of treatment with muraglitazar + metformin vs placebo + metformin | — |
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, Mexico, Peru, Puerto Rico, South Korea, Sweden, United Kingdom, United States
Outcome results
None listed