Safety and Efficacy Study of Empagliflozin and Metformin for 24 Weeks in Treatment Naive Patients With Type 2 Diabetes

NCT01719003 ↗

Phase 3 Completed 1413 enrolled Boehringer Ingelheim Eli Lilly and Company · collab

RandomizedParallel-groupDouble-blindTreatment

Summary

This study will investigate the efficacy and safety of two doses (high and low) of empagliflozin in combination with metformin (500 mg and 1000 mg) administered twice daily in patients with type 2 diabetes mellitus (T2DM). Study will compare four dose combinations of empagliflozin + metformin versus each individual component after 24 weeks of treatment.

Timeline

Start: 2012-10
Primary completion: 2014-11
Completion: 2014-12

Outcome

Met primary endpoint

registry analysis (superiority or other test); Empagliflozin 12.5 mg Bid+ Metformin 1000 mg Bid vs Metformin 1000 mg Bid; p = 0.0056; Adjusted mean -0.33 (95% CI -0.56 to -0.10) NCT01719003 ↗

paper Reductions in HbA1c were significantly greater with empagliflozin + metformin twice-daily regimens than with empagliflozin once-daily regimens (P < 0.001) PMID 27493136 ↗

Publications

Hadjadj S, Rosenstock J, Meinicke T, Woerle HJ, Broedl UC. Initial Combination of Empagliflozin and Metformin in Patients With Type 2 Diabetes. Diabetes Care. 2016 Oct;39(10):1718-28. doi: 10.2337/dc16-0522. Epub 2016 Aug 4.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Empagliflozin	Small molecule	5 mg	Oral
Subject	Empagliflozin	Small molecule	10 mg	Oral
Subject	Empagliflozin	Small molecule	12.5 mg	Oral
Subject	Empagliflozin	Small molecule	25 mg	Oral
Subject	Metformin	Small molecule	500 mg	Oral
Subject	Metformin	Small molecule	1000 mg	Oral