Safety and Efficacy in Type 2 Diabetic Patients With Severe Chronic Renal Impairment, 5 mg BI 1356 (Linagliptin) vs. Placebo, Insulin Background Inclusive

Summary

to determine safety, efficacy and tolerability of BI 1356 versus placebo

Timeline

Start

2008-12

Primary completion

2011-01

Completion

—

Outcome

Met primary endpoint

registry p < 0.0001; Mean Difference (Final Values) -0.60 (95% CI -0.89 to -0.31); ANCOVA NCT00800683 ↗

Publications

• McGill JB, Barnett AH, Lewin AJ, Patel S, Neubacher D, von Eynatten M, Woerle HJ. Linagliptin added to sulphonylurea in uncontrolled type 2 diabetes patients with moderate-to-severe renal impairment. Diab Vasc Dis Res. 2014 Jan;11(1):34-40. doi: 10.1177/1479164113507068. Epub 2013 Oct 29.

Drugs

Indications