Linagliptin in Combination With Metformin in Treatment Naive Patients With Type 2 Diabetes Mellitus and Insufficient Glycaemic Control

Phase 4 Completed 689 enrolled Boehringer Ingelheim Eli Lilly and Company · collab

RandomizedParallel-groupDouble-blindTreatment

Summary

The aim of this study is to investigate the impact of the combination therapy of linagliptin and metformin at submaximal doses in reduction of Glycosylated haemoglobin (HbA1c) and metformin pre-specified gastro-intestinal (GI) side effects in treatment naive patients of with type 2 diabetes mellitus.

Timeline

Start: 2011-11
Primary completion: 2013-03
Completion: 2013-03

Outcome

Met primary endpoint

registry analysis (non-inferiority or equivalence test); Lina 5mg + Met qd vs Met Bid; p <0.0001 NCT01438814 ↗

Publications

Ji L, Zinman B, Patel S, Ji J, Bailes Z, Thiemann S, Seck T. Efficacy and safety of linagliptin co-administered with low-dose metformin once daily versus high-dose metformin twice daily in treatment-naive patients with type 2 diabetes: a double-blind randomized trial. Adv Ther. 2015 Mar;32(3):201-15. doi: 10.1007/s12325-015-0195-3. Epub 2015 Mar 25.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Linagliptin	Unknown	5 mg	—
Subject	Metformin	Small molecule	1000 mg	—
Subject	Metformin	Small molecule	2000 mg	—