The Effect of Linagliptin (BI 1356) on 24h-glucose Control and Various Biomarkers in Type 2 Diabetic Patients

Summary

The objective of this study is to investigate the effect of BI 1356 on 24-h glucose control and various pharmacodynamic parameters in type 2 diabetic patients with inadequate glycaemic control.

Timeline

Start

2008-07

Primary completion

2008-11

Completion

—

Outcome

Met primary endpoint

registry analysis (superiority or other test); Placebo vs BI1356; p <0.0001; Mean Difference (Final Values) -19.9 (95% CI -28.0 to -11.9); ANCOVA NCT00716092 ↗

registry analysis (superiority or other test); Placebo vs BI1356; p <0.0001; Mean Difference (Final Values) 18.1 (95% CI 12.4 to 23.9); ANCOVA NCT00716092 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Linagliptin	Unknown	5 mg	Oral
Comparator	Sitagliptin	Small molecule	100 mg	Oral

Indications