A Trial to Evaluate BMS-298585 as Monotherapy in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 3

Conditions: Diabetes, Type 2

Treatments: Drug: Muraglitazar

Study type: Interventional

Funder types: Industry

Identifiers

NCT00246987

CV168-018

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind