Safety and Efficacy of Linagliptin (BI 1356) Plus Metformin in Type 2 Diabetes, Factorial Design

Summary

The objective of the randomised part of the study is to investigate the efficacy and safety of BI 1356 plus metformin compared to BI 1356 or metformin alone given for 24 weeks to drug naive or previously treated (4 weeks wash-out, 2 weeks placebo run-in) type 2 diabetic patients with insufficient glycaemic control. For the open-label part of the study the objective is to estimate the efficacy and safety of BI 1356 and metformin in type 2 diabetic patients with very poor glycaemic control for 24 weeks

Timeline

Start

2008-12

Primary completion

2010-05

Completion

—

Outcome

Met primary endpoint

registry analysis (superiority or other test); M500BID vs L2.5+M500BID; p <0.0001; Mean Difference (Final Values) -0.58 (95% CI -0.79 to -0.36) NCT00798161 ↗

registry analysis (superiority or other test); M1000BID vs L2.5+M1000BID; p <0.0001; Median Difference (Final Values) -0.51 (95% CI -0.73 to -0.30) NCT00798161 ↗

registry analysis (superiority or other test); Lina5 vs L2.5+M500BID; p <0.0001; Mean Difference (Final Values) -0.77 (95% CI -0.99 to -0.55) NCT00798161 ↗

registry analysis (superiority or other test); Lina5 vs L2.5+M1000BID; p <0.0001; Mean Difference (Final Values) -1.14 (95% CI -1.36 to -0.92) NCT00798161 ↗

Publications

• Lv Q, Shen J, Miao L, Ye B, Schepers C, Plat A, Shi Y. Early Combination Therapy with Linagliptin and Metformin in People with Type 2 Diabetes Improves Glycemic Control to HbA1c </= 6.5% without Increasing Hypoglycemia: Pooled Analysis of Two Randomized Clinical Trials. Diabetes Ther. 2020 Jun;11(6):1317-1330. doi: 10.1007/s13300-020-00819-9. Epub 2020 Apr 23.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Linagliptin	Unknown	2.5 mg	—
Subject	Linagliptin	Unknown	5 mg	—
Subject	Metformin	Small molecule	500 mg	—
Subject	Metformin	Small molecule	1000 mg	—

Indications