A Pilot Study of BMS-512148 in Subjects With Type 2 Diabetes

Completed · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Type 2 Diabetes

In brief

The purpose of this clinical research study is to learn if BMS-512148, added to insulin and one or two anti-diabetes medications (metformin and/or pioglitazone or rosiglitazone), can help reduce the blood sugar levels compared to insulin and one or two anti-diabetes medications (metformin and/or pioglitazone or rosiglitazone) alone, in subjects with type 2 diabetes. The safety of this treatment will also be studied.

Key facts

Study ID

NCT00357370

Run by

AstraZeneca

People needed

163

Starts

2006-10-01

Expected to finish

2008-03-01

Last updated by the study team

2017-05-11

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Males and females, 18 to 75 years old, with type 2 diabetes with inadequate glycemic control
• Subjects receiving insulin and metformin and/or a thiazolidinedione
• Body Mass Index <=45.0 kg/m2
• Serum creatinine <1.5 mg/dL for men or <1.4 mg/dL for women
• No overt proteinuria (in subjects with a microalbumin/creatinine ratio ≥300 mg/g, the 24-hour urinary excretion of total protein must be <3 g/24 hrs)

You may not qualify if…

• History of type 1 diabetes
• AST and/or ALT >2.5 times the upper limit of normal
• Creatinine kinase ≥3 times the upper limit of normal
• Symptoms of severely uncontrolled diabetes
• History of hypoglycemic unawareness
• Currently unstable or serious cardiovascular, renal, hepatic, hematological, oncological, endocrine, psychiatric, or rheumatic diseases

Where it is running

• Nea Clinic — Jonesboro, Arkansas, United States
• Valley Research — Fresno, California, United States
• Bernstein, Richard — Greenbrae, California, United States
• Jacksonville Center For Clinical Research — Jacksonville, Florida, United States
• Endocrine Research Solutions, Inc. — Roswell, Georgia, United States
• Indiana University — Indianapolis, Indiana, United States
• Model Clinical Research Llc — Baltimore, Maryland, United States
• University Of Michigan — Ann Arbor, Michigan, United States
• St. Louis Center For Clinical Research — St Louis, Missouri, United States
• Suny Upstate Medical University — Syracuse, New York, United States
• Mountain Diabetes And Endocrine Center — Asheville, North Carolina, United States
• Your Diabetes Endocrine Nutrition Group — Mentor, Ohio, United States
• Research Institute Of Dallas, P.A. — Dallas, Texas, United States
• Diabetes And Glandular Disease Research Associates, P.A. — San Antonio, Texas, United States
• Rainier Clinical Research Center — Renton, Washington, United States
• Advanced Healthcare S.C. — Milwaukee, Wisconsin, United States
• Local Institution — Winnipeg, Manitoba, Canada
• Local Institution — Bathurst, New Brunswick, Canada
• Local Institution — Gatineau, Quebec, Canada
• Local Institution — Laval, Quebec, Canada
• Local Institution — Longueuil, Quebec, Canada
• Local Institution — Pointe-Claire, Quebec, Canada
• Local Institution — Sherbrooke, Quebec, Canada

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.