Evaluate Efficacy and Safety in Japanese Subjects With Type 2 Diabetes Mellitus

Summary

This is a 24-week randomised, multi-centre phase III study to evaluate the efficacy and safety of dapagliflozin as monotherapy in Japanese subjects with Type 2 diabetes mellitus who have inadequate glycemic control with diet and exercise.

Timeline

Start

2011-02

Primary completion

2012-03

Completion

2012-03

Outcome

Met primary endpoint

registry Dapagliflozin 5 mg vs Placebo; p <0.0001; Mean Difference (Final Values) -0.35 (95% CI -0.52 to -0.18); ANCOVA NCT01294423 ↗

registry Dapagliflozin 10 mg vs Placebo; p <0.0001; Mean Difference (Final Values) -0.39 (95% CI -0.56 to -0.23); ANCOVA NCT01294423 ↗

Publications

• Background Kaku K, Kiyosue A, Inoue S, Ueda N, Tokudome T, Yang J, Langkilde AM. Efficacy and safety of dapagliflozin monotherapy in Japanese patients with type 2 diabetes inadequately controlled by diet and exercise. Diabetes Obes Metab. 2014 Nov;16(11):1102-10. doi: 10.1111/dom.12325. Epub 2014 Jul 8.
• Natale P, Tunnicliffe DJ, Toyama T, Palmer SC, Saglimbene VM, Ruospo M, Gargano L, Stallone G, Gesualdo L, Strippoli GF. Sodium-glucose co-transporter protein 2 (SGLT2) inhibitors for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2024 May 21;5(5):CD015588. doi: 10.1002/14651858.CD015588.pub2.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Dapagliflozin	Small molecule	5 mg	Oral
Subject	Dapagliflozin	Small molecule	10 mg	Oral

Indications