Linagliptin as Add on Therapy to Empagliflozin 10 mg or 25 mg With Background Metformin in Patient With Type 2 Diabetes

Phase 3 Completed 708 enrolled Boehringer Ingelheim Eli Lilly and Company · collab

RandomizedParallel-groupDouble-blindTreatment

Summary

The objective of the study is to investigate the efficacy, safety and tolerability of linagliptin 5 mg qd compared to placebo given for 24 weeks in inadequately controlled T2DM patients on empagliflozin 10 mg or 25 mg and maximum tolerated dose of metformin. The primary objective of efficacy evaluation is planned after 24 weeks of treatment. The study is designed to show superiority of the combination of empagliflozin and linagliptin over empagliflozin alone.

Timeline

Start: 2013-01
Primary completion: 2015-03
Completion: 2015-03

Publications

Tinahones FJ, Gallwitz B, Nordaby M, Gotz S, Maldonado-Lutomirsky M, Woerle HJ, Broedl UC. Linagliptin as add-on to empagliflozin and metformin in patients with type 2 diabetes: Two 24-week randomized, double-blind, double-dummy, parallel-group trials. Diabetes Obes Metab. 2017 Feb;19(2):266-274. doi: 10.1111/dom.12814. Epub 2016 Nov 24.

Drugs

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

Linagliptin as Add on Therapy to Empagliflozin 10 mg or 25 mg With Background Metformin in Patient With Type 2 Diabetes

Summary

Timeline

Publications

Drugs

Indications