Study to Compare the Efficacy and Safety of Administration of the Fix Dose Combination of Linagliptin Plus Metformin in Drug naïve Type 2 Patients

Summary

Reduced factorial design study with 24 week randomized treatment of initial combination therapy with linagliptin and metformin in T2DM patients

Timeline

Start

2012-10

Primary completion

2014-04

Completion

2014-04

Outcome

Sources disagree · no verdict is set; each source's reading is shown below

registry Main: Metformin 1000mg BID vs Main: Linagliptin 2.5mg / Metformin 1000mg BID; p = 0.0587; Mean Difference (Final Values) -0.22 (95% CI -0.45 to 0.01); ANCOVA reads as mixed primary results NCT01708902 ↗

registry Main: Metformin 1000mg BID vs Main: Linagliptin 2.5mg / Metformin 1000mg BID; p = 0.0109; Mean Difference (Final Values) -0.30 (95% CI -0.53 to -0.07); ANCOVA reads as mixed primary results NCT01708902 ↗

registry APG: Linagliptin 5mg QD vs APG: Linagliptin 2.5mg / Metformin 1000mg BID; p = 0.0001; Mean Difference (Final Values) -1.25 (95% CI -1.87 to -0.63); ANCOVA reads as mixed primary results NCT01708902 ↗

release “initial therapy with the combination of linagliptin and metformin reduced A1C levels from baseline by 2.9 percent compared with 2.0 percent for linagliptin alone.” reads as met primary endpoint lilly.com ↗

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	Oral
Subject	Linagliptin	Unknown	5 mg	Oral
Subject	Metformin	Small molecule	500 mg	Oral
Subject	Metformin	Small molecule	1000 mg	Oral

Indications