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

• Status: Completed
• Trial end date: 2013-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Collaborator: Bristol-Myers Squibb
• Treatments: Dapagliflozin; Metformin

Criteria

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