Safety and Efficacy of Combination Saxagliptin & Dapagliflozin Added to Metformin to Treat Subjects With Type 2 Diabetes

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Type 2 Diabetes

Treatments: Drug: Placebo matching with Dapagliflozin; Drug: Placebo matching with Saxagliptin; Drug: Metformin XR; Drug: Dapagliflozin; Drug: Saxagliptin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01606007

2012-000679-18 (EudraCT Number)

CV181-169

Details and patient eligibility

About

The purpose of this study is to learn if a combination of BMS-477118 (Saxagliptin) and BMS -512148 (Dapagliflozin) added to Metformin can improve (decrease) Glycosylated Hemoglobin (Hemoglobin A1c) in patients with type 2 diabetes after 24 weeks of treatment. The safety of this treatment will also be studied.

Enrollment: 1,282 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects with Type 2 diabetes mellitus (T2DM) with HbA1c ≥ 8.0% and ≤ 12.0%
• Stable metformin therapy dose of ≥ 1500mg for at least 8 weeks prior to screening
• Body mass index (BMI) ≤ 45.0kg/m2

Exclusion criteria

• Estimated glomerular filtration rate (eGFR) < 60mL/min/1,73m2 and Serum Creatinine (Scr) ≥ 1.5 mg/dL in males or ≥ 1.4 mg/dL in females
• Uncontrolled hypertension Systolic Blood Pressure (SBP) ≥ 160mmHg and/or Diastolic Blood Pressure (DBP) ≥ 100mmHg
• Hepatic disease
• Cardiovascular disease within 3 months

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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1,282 participants in 3 patient groups

Arm 1: Saxagliptin+Metformin XR+Placebo

Active Comparator group

Treatment:

Drug: Saxagliptin

Drug: Metformin XR

Drug: Placebo matching with Dapagliflozin

Arm 2: Dapagliflozin+Metformin XR+Placebo

Active Comparator group

Treatment:

Drug: Dapagliflozin

Drug: Placebo matching with Saxagliptin

Drug: Metformin XR

Arm 3: Saxagliptin+Dapagliflozin+Metformin XR

Experimental group

Treatment:

Drug: Saxagliptin

Drug: Dapagliflozin

Drug: Metformin XR