Study of Dapagliflozin in Combination With Metformin XR to Initiate the Treatment of Type 2 Diabetes

Summary

The primary purpose of this study is to compare the change from baseline in hemoglobin A1C achieved with dapagliflozin 10 mg in combination with metformin XR as compared with metformin XR monotherapy and compared with Dapagliflozin monotherapy, after 24 weeks of oral administration of double-blind treatment. The safety of treatment with dapagliflozin will also be assessed in this study

Timeline

Start

2009-04

Primary completion

2010-05

Completion

2010-05

Outcome

Met primary endpoint

registry analysis (superiority or other test); Dapagliflozin + Metformin XR vs Dapagliflozin; p <0.0001; Mean Difference (Final Values) -0.53 (95% CI -0.74 to -0.32); ANCOVA NCT00859898 ↗

registry analysis (superiority or other test); Dapagliflozin + Metformin XR vs Metformin XR; p <0.0001; Mean Difference (Final Values) -0.54 (95% CI -0.75 to -0.33); ANCOVA NCT00859898 ↗

release “In both studies, a statistically significant reduction in HbA1c from baseline, the primary study endpoint, was seen in individuals treated with dapagliflozin plus metformin XR” bms.com ↗

Publications

• Kohan DE, Fioretto P, Johnsson K, Parikh S, Ptaszynska A, Ying L. The effect of dapagliflozin on renal function in patients with type 2 diabetes. J Nephrol. 2016 Jun;29(3):391-400. doi: 10.1007/s40620-016-0261-1. Epub 2016 Feb 19.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Dapagliflozin	Small molecule	10 mg	Oral
Comparator	Metformin XR	Small molecule	2000 mg	Oral

Indications