Dose Ranging Study With LT, Monotherapy, PPAR

Phase 2

Completed

• Conditions: Diabetes Mellitus II

• Registration Number: NCT00240383
• Lead Sponsor: Bristol-Myers Squibb

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

Detailed Description

Not available

Study Timeline

• Study Start: 2002-05
• Study First Submitted: 2005-10-17
• Study First Submitted QC: 2005-10-17
• Study First Posted: 2005-10-18
• Primary Completion: 2006-06
• Study Completion: 2006-06
• Status Verified: 2008-06
• Disposition First Submitted: 2010-09-10
• Disposition First Submitted QC: 2010-09-10
• Last Update Submitted: 2010-09-10
• Disposition First Posted: 2010-09-14
• Last Update Posted: 2010-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1260

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Local Institution; 🇬🇧 Glasgow, United Kingdom