Safety and Efficacy of the Combination of Empagliflozin and Linagliptin Compared to Linagliptin Alone Over 24 Weeks in Patients With Type 2 Diabetes

Summary

This trial compare the use of two different doses of Empagliflozin to placebo, in T2DM patients on 16 wks linagliptin treatment and metformin background therapy.

Timeline

Start

2013-02-08

Primary completion

2015-03-23

Completion

2015-03-23

Outcome

Met primary endpoint

registry analysis (unspecified test); Empagliflozin 25 mg vs Placebo; p <0.0001; Mean Difference (Final Values) -0.70 (95% CI -0.93 to -0.46); Mixed Models Analysis NCT01734785 ↗

registry analysis (unspecified test); Empagliflozin 10 mg vs Placebo; p <0.0001; Mean Difference (Final Values) -0.79 (95% CI -1.02 to -0.55); Mixed Models Analysis NCT01734785 ↗

Publications

• Softeland E, Meier JJ, Vangen B, Toorawa R, Maldonado-Lutomirsky M, Broedl UC. Empagliflozin as Add-on Therapy in Patients With Type 2 Diabetes Inadequately Controlled With Linagliptin and Metformin: A 24-Week Randomized, Double-Blind, Parallel-Group Trial. Diabetes Care. 2017 Feb;40(2):201-209. doi: 10.2337/dc16-1347. Epub 2016 Dec 2.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Empagliflozin	Small molecule	10 mg	Oral
Subject	Empagliflozin	Small molecule	25 mg	Oral
Comparator	Linagliptin	Unknown	5 mg	Oral

Indications