Linagliptin and Metformin Versus Linagliptin in Newly Diagnosed, Untreated Type 2 Diabetes

Phase 4 Completed 316 enrolled Boehringer Ingelheim Eli Lilly and Company · collab

RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this trial is to determine whether a initial combination of linagliptin and metformin compared to linagliptin alone for 24 weeks is effective in newly diagnosed, treatment-naïve patients with Type 2 Diabetes.

Timeline

Start: 2012-01
Primary completion: 2013-04
Completion: 2013-04

Outcome

Met primary endpoint

registry Linagliptin 5mg + Metformin vs Linagliptin 5mg; p <0.0001; Mean Difference (Final Values) -0.79 (95% CI -1.13 to -0.46) NCT01512979 ↗

Publications

Ross SA, Caballero AE, Del Prato S, Gallwitz B, Lewis-D'Agostino D, Bailes Z, Thiemann S, Patel S, Woerle HJ, von Eynatten M. Linagliptin plus metformin in patients with newly diagnosed type 2 diabetes and marked hyperglycemia. Postgrad Med. 2016 Nov;128(8):747-754. doi: 10.1080/00325481.2016.1238280. Epub 2016 Sep 29.

Drugs

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