Safety and Efficacy of Dapagliflozin as Monotherapy in Subjects With Type 2 Diabetes

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Dapagliflozin; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00736879

MB102-032

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 diet and exercise alone. The safety of this treatment will also be studied

Enrollment: 497 patients

Sex: All

Ages: 18 to 77 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male and females, ≥18 to ≤77 years old, with type 2 diabetes mellitus
• Subjects must have central laboratory pre-randomization A1C ≥7.0 and ≤ 10.0%
• C-peptide ≥ 1.0 ng/mL (0.34 nmol/L)
• Body Mass Index ≤ 45 kg/m²
• Must be able to perform self monitoring of blood glucose

Exclusion criteria

• aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) >3* upper limit of normal (ULN)
• Serum Total bilirubin >2 mg/dL (34.2 µmol/L)
• Creatinine kinase >3* ULN
• Serum creatinine ≥1.50 mg/dL (133 µmol/L) for male subjects, ≥1.40 mg/dL (124 µmol/L) for female subjects
• 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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497 participants in 4 patient groups, including a placebo group

Dapagliflozin 1 mg

Experimental group

Description:

Dapagliflozin: 1 mg

Treatment:

Drug: Dapagliflozin

Dapagliflozin 2.5 mg

Experimental group

Description:

Dapagliflozin: 2.5 mg

Treatment:

Drug: Dapagliflozin

Dapagliflozin 5 mg

Experimental group

Description:

Dapagliflozin: 5 mg

Treatment:

Drug: Dapagliflozin

Placebo

Placebo Comparator group

Description:

Placebo: 0 mg

Treatment:

Drug: Placebo