A phase III randomised, double-blind, placebo-controlled parallel group study to compare the efficacy and safety of twice daily administration of the free combination of BI 1356 2.5 mg + metformin 500 mg, or of BI 1356 2.5 mg + metformin 1000 mg, with the individual components of metformin (500 mg or 1000 mg, twice daily), and BI 1356 (5.0 mg, once daily) over 24 weeks in drug naïve or previously treated (4 weeks wash-out and 2 weeks placebo run-in) type 2 diabetic patients with insufficient glycaemic control
Phase of Trial: Phase III
Latest Information Update: 05 Mar 2018
At a glance
- Drugs Linagliptin (Primary) ; Metformin
- Indications Type 2 diabetes mellitus
- Focus Registrational; Therapeutic Use
- Sponsors Boehringer Ingelheim Pharmaceuticals
- 17 Aug 2017 Results (n=2065) of pooled analysis of this and other similar 15 studies assessing efficacy and safety based upon age, obesity, and renal function, published in the Advances in Therapy.
- 31 May 2016 According to Boehringer Ingelheim media release, the U.S. Food and Drug Administration (FDA) has approved Jentadueto XR (linagliptin and metformin hydrochloride extended-release) tablets for the treatment of type 2 diabetes (T2D) in adults.
- 17 Sep 2013 Data will be presented at the 49th Annual Meeting of the European Association for the Study of Diabetes (EASD), according to a Boehringer Ingelheim and Eli Lilly media release.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History