Diabetes, Type 2
Conditions
Brief summary
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.
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
* 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in HbA1c from baseline to Week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Australia, Canada, Mexico, Poland, Puerto Rico, Taiwan, United States
Outcome results
None listed