At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase III, Randomized, Double-blind, Parallel Group Study to Evaluate the Efficacy and Safety of Linagliptin 5 mg Compared to Placebo, Administered as Oral Fixed Dose Combination With Empagliflozin 10 mg or 25 mg for 24 Weeks, in Patients With Type 2 Diabetes Mellitus and Insufficient Glycaemic Control After 16 Weeks of Treatment With Empagliflozin 10 mg or 25 mg on Metformin Background Therapy
In Brief
A Phase 3 clinical trial evaluating BI 10773, BI 10773 Placebo, and 2 other interventions for Diabetes Mellitus, Type 2. Completed, enrolled 708 participants across 114 sites in 11 countries.
Detailed Summary
The objective of the study is to investigate the efficacy, safety and tolerability of linagliptin 5 mg qd compared to placebo given for 24 weeks in inadequately controlled T2DM patients on empagliflozin 10 mg or 25 mg and maximum tolerated dose of metformin. The primary objective of efficacy evaluation is planned after 24 weeks of treatment. The study is designed to show superiority of the combination of empagliflozin and linagliptin over empagliflozin alone.
Study Details
Timeline
Interventions
Empagliflozin active
Empagliflozin placebo
Empagliflozin / Linagliptin 25/5 mg Dose FDC active
Empagliflozin active
Empagliflozin / Linagliptin 10/5 mg Dose FDC active
Empagliflozin / Linagliptin 10/5 mg Dose placebo FDC
Empagliflozin active
Empagliflozin active
Empagliflozin active
Empagliflozin / Linagliptin 25/5 mg Dose FDC placebo
Empagliflozin placebo
Empagliflozin / Linagliptin 10/5 mg Dose FDC placebo
Empagliflozin active
Empagliflozin / Linagliptin 25/5 mg Dose FDC placebo