Add-on to Thiazolidinedione (TZD) Failures

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Type 2 Diabetes

Treatments: Drug: Placebo matching Dapagliflozin; Drug: Thiazolidinedione (Pioglitazone); Drug: Dapagliflozin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00683878

MB102-030

Details and patient eligibility

About

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

Enrollment: 972 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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972 participants in 3 patient groups, including a placebo group

Arm 1

Experimental group

Treatment:

Drug: Thiazolidinedione (Pioglitazone)

Drug: Dapagliflozin

Drug: Dapagliflozin

Arm 2

Experimental group

Treatment:

Drug: Thiazolidinedione (Pioglitazone)

Drug: Dapagliflozin

Drug: Dapagliflozin

Arm 3

Placebo Comparator group

Treatment:

Drug: Thiazolidinedione (Pioglitazone)

Drug: Placebo matching Dapagliflozin