At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 607 enrolled
Drug / intervention
Linagliptin +5 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase III, Randomised, Double-blind, Parallel Group, 24 Week Study to Evaluate Efficacy and Safety of Once Daily Empagliflozin 10 mg and 25 mg Compared to Placebo, All Administered as Oral Fixed Dose Combinations With Linagliptin 5 mg, in Patients With Type 2 Diabetes Mellitus and Insufficient Glycaemic Control After 16 Weeks Treatment With Linagliptin 5 mg Once Daily on Metformin Background Therapy.
In Brief
A Phase 3 clinical trial evaluating Linagliptin, Empagliflozin + Linagliptin, and 1 other intervention for Diabetes Mellitus, Type 2. Completed, enrolled 607 participants across 90 sites in 11 countries.
Detailed Summary
This trial compare the use of two different doses of Empagliflozin to placebo, in T2DM patients on 16 wks linagliptin treatment and metformin background therapy.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus, Type 2
CountriesAustralia, Brazil, Canada, El Salvador, France, New Zealand, Norway, South Korea, Spain, Taiwan, United States
CollaboratorsEli Lilly and Company
Timeline
Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedNov 2012
Enrollment StartFeb 2013
Primary CompletionMar 2015
TodayJul 2026
First PostedNov 28, 2012
Enrollment StartFeb 8, 2013
Primary CompletionMar 23, 2015
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 13.6 years ago
Interventions
Linagliptindrug
tablet
Empagliflozin + Linagliptindrug
Fixed dose combination.
Empagliflozin + Linagliptindrug
Fixed dose combination
Empagliflozin + Linagliptindrug
Fixed dose combination
Empagliflozin placebo + Linagliptin placebodrug
Matching Empagliflozin + Linagliptin low dose
Empagliflozin + Linagliptindrug
Fixed dose combination.