Diabetes Mellitus II
Conditions
Brief summary
A Randomized, Double-Blind, Dose-Ranging, Dose Comparison-Controlled Trial to Determine the Safety and Efficacy of BMS-298585 in Subjects with Type 2 Diabetes
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
* 1\. HbA1c \> 7.0% and ≤ 10.0% obtained at the Screening visit. * 2\. Men and women, 18-70 years of age Established Type 2 diabetes
Exclusion criteria
* 1\. Symptomatic Type 2 diabetes defined as marked polyuria and polydipsia with greater than 10% weight loss during the last three months. * 2\. Administration of antihyperglycemic agents (other than thiazolidinediones) for more than three consecutive or a total of seven non-consecutive days during the four weeks prior to screening. * 3\. Administration of thiazolidinediones for more than three consecutive or a total of seven non-consecutive days during the six weeks prior to screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare, after 24 weeks of oral administration of double-blind treatment, the change from baseline in hemoglobin A1c (HbA1c) achieved with the highest dose and subsequent doses of BMS-298585 versus the lowest dose of BMS-298585 in subjects with Type 2 | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess, after 12 and 24 weeks of oral administration of double-blind therapy, the percent change from baseline in fasting lipids (total cholesterol,low density lipoprotein cholesterol,HDL-C, TG, non-HDL chol | — |
Countries
Argentina, Australia, Brazil, Canada, Czechia, France, Italy, Mexico, Netherlands, Poland, Puerto Rico, South Africa, Spain, Sweden, United Kingdom, United States
Outcome results
None listed