Add-on to Thiazolidinedione (TZD) Failures

• Status: Completed
• Trial end date: 2010-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this clinical research study is to learn if BMS-512148 (Dapagliflozin) can help reduce the blood sugar levels in subjects with Type 2 Diabetes who are not well controlled on TZD alone. The safety of this treatment will also be studied

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

Details

• Lead Sponsor: AstraZeneca
• Collaborator: Astra Zeneca, Bristol-Myers Squibb
• Treatments: 2,4-thiazolidinedione; Dapagliflozin; Pioglitazone

Criteria

Inclusion Criteria:

• Males and females, ≥ 18 years old, with type 2 diabetes and with inadequate glycemic control

• All subjects must have central laboratory pre-randomization A1C ≥ 7.0 and ≤ 10.5%

• C-peptide ≥ 1.0 ng/mL (0.34 nmol/L)

• Body Mass Index ≤ 45.0 kg/m²

Exclusion Criteria:

• AST and /or ALT > 2.5 times the upper limit of normal

• Serum total bilirubin > 2 mg/dL (34.2 µmol/L)

• Creatinine kinase > 3.0 times the upper limit of normal

• Symptoms of severely uncontrolled diabetes

• Serum creatinine ≥ 2.0 mg/dL

• Calculated Cr-Clearance < 50 ml/min (calculated by Cockroft-Gault formula)

• Currently unstable or serious cardiovascular, renal, hepatic, hematological, oncological, endocrine, psychiatric, or rheumatic diseases