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

• Status: Completed
• Trial end date: 2008-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Collaborator: Bristol-Myers Squibb
• Treatments: Dapagliflozin

Criteria

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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