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

Phase 3

Completed

• Conditions: Diabetes, Type 2

• Registration Number: NCT00246987
• Lead Sponsor: Bristol-Myers Squibb

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-06
• Study Completion: 2004-04
• Study First Submitted: 2005-10-28
• Study First Submitted QC: 2005-10-28
• Study First Posted: 2005-11-01
• Status Verified: 2012-04
• Last Update Submitted: 2012-04-26
• Last Update Posted: 2012-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 341

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in HbA1c from baseline to Week 24

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (2)

Local Institution; 🇨🇳 Taichung, Taiwan

Tasmania; 🇦🇺 Melbourne, Victoria, Australia