A Phase III Study of BMS-512148 (Dapagliflozin) in Patients With Type 2 Diabetes Who Are Not Well Controlled on Metformin Alone

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Type 2 Diabetes

Treatments: Drug: Dapagliflozin; Drug: Metformin; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00528879

MB102-014 (Other Identifier)

MB102-014 LT

Details and patient eligibility

About

The purpose of this clinical research study is to learn whether dapagliflozin can help reduce blood sugar levels in participants with Type 2 diabetes that is not well controlled on metformin alone. The safety of this treatment will also be studied.

Enrollment: 915 patients

Sex: All

Ages: 18 to 77 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria

• Males and females, 18 to 77 years old, with type 2 diabetes and inadequate glycemic control
• Participants who have been receiving metformin at a total daily dose ≥1500 mg per day for at least 8 weeks
• C-peptide ≥1.0 ng/mL
• Body mass index ≤45.0 kg/m^2
• Serum creatinine level <1.50 mg/dL for men or <1.40 mg/dL for women.

Key Exclusion Criteria

• Aspartate aminotransferase and/or alanine aminotransferase level >3.0 times the upper limit of normal
• Serum total bilirubin level >2 mg/dL
• Creatinine kinase level >3 times upper limit of normal
• Symptoms of severely uncontrolled diabetes
• Serum creatinine level ≥1.50 mg/dL for men or ≥1.40 mg/dL for women
• Currently unstable or serious cardiovascular, renal, hepatic, hematologic, oncologic, endocrine, psychiatric, or rheumatic diseases

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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915 participants in 4 patient groups, including a placebo group

Placebo + Metformin

Placebo Comparator group

Description:

Participants received dapagliflozin-matching placebo once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks

Treatment:

Drug: Metformin

Drug: Placebo

Dapagliflozin, 2.5 mg + Metformin

Experimental group

Description:

Participants received dapagliflozin, 2.5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks

Treatment:

Drug: Metformin

Drug: Dapagliflozin

Dapagliflozin, 5 mg + Metformin

Experimental group

Description:

Participants received dapagliflozin, 5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks

Treatment:

Drug: Metformin

Drug: Dapagliflozin

Dapagliflozin, 10 mg + Metformin

Experimental group

Description:

Participants received dapagliflozin, 10 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks

Treatment:

Drug: Metformin

Drug: Placebo

Drug: Dapagliflozin