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

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.

Timeline

Start

2011-10

Primary completion

2013-01

Completion

2013-08

Outcome

Met primary endpoint

registry LEAST_SQUARES_MEAN Dapagliflozin 10mg Plus Metformin Plus Sulfonylurea: -0.86 (-1.00 to -0.72) Percent NCT01392677 ↗

registry analysis (superiority or other test); Placebo Plus Metformin Plus Sulfonylurea vs Dapagliflozin 10mg Plus Metformin Plus Sulfonylurea; p <0.0001 NCT01392677 ↗

registry Mean Difference (Final Values) -0.69 (95% CI -0.89 to -0.49) NCT01392677 ↗

release “Patients treated with dapagliflozin 10 mg as an add-on therapy to metformin plus sulfonylurea demonstrated significant improvements in glycosylated hemoglobin levels (HbA1c)” astrazeneca.com ↗

release “Dapagliflozin added to metformin plus sulfonylurea demonstrated significantly greater improvements in HbA1c from baseline compared to placebo” bms.com ↗

Publications

• Matthaei S, Bowering K, Rohwedder K, Grohl A, Parikh S; Study 05 Group. Dapagliflozin improves glycemic control and reduces body weight as add-on therapy to metformin plus sulfonylurea: a 24-week randomized, double-blind clinical trial. Diabetes Care. 2015 Mar;38(3):365-72. doi: 10.2337/dc14-0666. Epub 2015 Jan 15.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Dapagliflozin	Small molecule	10 mg	Oral

Indications