Phase III Insulin Add-On Asia Regional Program - ST

NCT02096705 ↗

Phase 3 Completed 477 enrolled AstraZeneca Bristol-Myers Squibb · collab

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose is to determine if after 24 weeks of oral daily administration, there will be a greater mean reduction from baseline in glycosylated hemoglobin (HbA1c) achieved with Dapagliflozin 10 mg plus insulin compared to placebo plus insulin in subjects with type 2 diabetes.

Timeline

Start: 2014-03-31
Primary completion: 2016-01-28
Completion: 2016-01-28

Outcome

Met primary endpoint

registry Placebo vs Dapagliflozin; p <0.0001; Mean Difference (Final Values) -0.90 (95% CI -1.09 to -0.71) NCT02096705 ↗

Publications

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	10 mg	Oral