Evaluation of Safety and Efficacy of Dapagliflozin in Subjects With Type 2 Diabetes Who Have Inadequate Glycaemic Control on Background Combination of Metformin and Sulfonylurea

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Inadequate Glycaemic Control; High HbA1c Level; Type 2 Diabetes Mellitus

Treatments: Drug: dapagliflozin; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01392677

D1693C00005

Details and patient eligibility

About

This study intends to compare the efficacy and safety of dapagliflozin versus placebo in patients with type 2 diabetes who have inadequate glycaemic control on a background combination of metformin and sulfonylurea.

Enrollment: 311 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Type 2 diabetes mellitus
• Men or women age ≥ 18 years old
• Stable dose combination of metformin and sulfonylurea
• HbA1c ≥7.7% and ≤11.0%

Exclusion criteria

• Type 1 diabetes mellitus or diabetes insipidus
• Recent cardiovascular events
• Kidney or urological disorders
• Hepatic disorders

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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311 participants in 2 patient groups, including a placebo group

Dapagliflozin 10 mg tablet

Experimental group

Treatment:

Drug: dapagliflozin

matching placebo tablet

Placebo Comparator group

Treatment:

Drug: placebo