This Study in Healthy People Tests Whether Taking a Low Strength of Empagliflozin, Linagliptin, and Metformin Together in 1 Pill is the Same as Taking Them in Separate Pills

Summary

The primary objective of this trial is to establish the bioequivalence of two empagliflozin/linagliptin/metformin extended release (XR) fixed dose combination (FDC) tablets (Test, T) compared with the same doses of the individual components given in separate tablets (Reference, R) when administered together after a high-fat, high-calorie meal. The assessment of safety and tolerability will be the secondary objective of this trial.

Timeline

Start

2018-08-27

Primary completion

2018-11-05

Completion

2018-11-05

Outcome

Met primary endpoint

registry analysis (equivalence test); Test Treatment (T) vs Reference Treatment (R); p <0.0001; Adjusted gMean ratio 100.42 (90% CI 98.17 to 102.72); ANOVA NCT03629054 ↗

registry analysis (equivalence test); Test Treatment (T) vs Reference Treatment (R); p <0.0001; Adjusted gMean ratio 95.34 (90% CI 91.58 to 99.24); ANOVA NCT03629054 ↗

registry analysis (equivalence test); Test Treatment (T) vs Reference Treatment (R); p <0.0001; Adjusted gMean ratio 100.16 (90% CI 96.17 to 104.31); ANOVA NCT03629054 ↗

registry analysis (equivalence test); Test Treatment (T) vs Reference Treatment (R); p = 0.0029; Adjusted gMean ratio 92.57 (90% CI 85.21 to 100.57); ANOVA NCT03629054 ↗

registry analysis (equivalence test); Test Treatment (T) vs Reference Treatment (R); p = 0.0001; Adjusted gMean ratio 97.33 (90% CI 89.99 to 105.26); ANOVA NCT03629054 ↗

registry analysis (equivalence test); Test Treatment (T) vs Reference Treatment (R); p <0.0001; Adjusted gMean ratio 104.83 (90% CI 98.56 to 111.50); ANOVA NCT03629054 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Empagliflozin	Small molecule	—	Oral
Subject	Linagliptin	Unknown	—	Oral
Subject	Metformin	Small molecule	—	Oral

Indications

No indication recorded.