drugset / Trial / NCT02453555

Empagliflozin Add on to Linagliptin Study in Japanese Patient With Type 2 Diabetes Mellitus

NCT02453555 ↗

Phase 3 Completed 275 enrolled Boehringer Ingelheim Eli Lilly and Company · collab
RandomizedParallel-groupDouble-blindTreatment

Summary

This trial will compare the use of fixed dose combination of empagliflozin and linagliptin to linagliptin alone in patient with type 2 diabetes mellitus

Timeline

Start
2015-05-14
Primary completion
2016-08-26
Completion
2017-03-27

Outcome

Met primary endpoint

registry analysis (superiority or other test); Empagliflozin 10 mg/Linagliptin 5 mg vs Linagliptin 5 mg + Placebo 10 mg; p <0.0001; Adjusted Mean Difference (Net) -1.14 (95% CI -1.36 to -0.91); Mixed Models Analysis NCT02453555 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Empagliflozin Small molecule 10 mg —
Subject Empagliflozin Small molecule 25 mg —
Comparator Linagliptin Unknown 5 mg —