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

Completed · Phase 3

Conditions studied: Diabetes, Type 2

In brief

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.

Key facts

Study ID

NCT00246987

Run by

Bristol-Myers Squibb

People needed

341

Starts

2003-06-01

Expected to finish

2004-04-01

Last updated by the study team

2012-04-27

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects with Type 2 diabetes
• Drug Naive
• HbA1c >= 7.0% and <= 10.0%
• Body Mass Index <= 41 kg/m2
• Serum TG <= 600 mg/dL

You may not qualify if…

• 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.

Where it is running

• Local Institution — Birmingham, Alabama, United States
• Local Institution — Haleyville, Alabama, United States
• Local Institution — Hoover, Alabama, United States
• Local Institution — Fayetteville, Arizona, United States
• Local Institution — Hot Springs, Arizona, United States
• Local Institution — Mesa, Arizona, United States
• Local Institution — Phoenix, Arizona, United States
• Local Institution — Tucson, Arizona, United States
• Local Institution — Tulsa, Arizona, United States
• Local Institution — Concord, California, United States
• Local Institution — Fountain Valley, California, United States
• Local Institution — Long Beach, California, United States
• Local Institution — Los Gatos, California, United States
• Local Institution — Raleigh, California, United States
• Local Institution — Roseville, California, United States
• Local Institution — San Diego, California, United States
• Local Institution — Spring Valley, California, United States
• Local Institution — Tustin, California, United States
• Local Institution — Colorado Springs, Colorado, United States
• Local Institution — Golden, Colorado, United States
• Local Institution — Littleton, Colorado, United States
• Local Institution — New Britain, Connecticut, United States
• Local Institution — Altamonte Springs, Florida, United States
• Local Institution — Brandon, Florida, United States
• Local Institution — Anniston, Alabama, United States

Full record on ClinicalTrials.gov

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