Dose Ranging Study With LT, Monotherapy, PPAR

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 3; Phase 2

Conditions: Diabetes Mellitus II

Treatments: Drug: Muraglitazar

Study type: Interventional

Funder types: Industry

Identifiers

NCT00240383

CV168-006

Details and patient eligibility

About

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

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind