At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 275 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, 52 Week Study to Evaluate Efficacy and Safety of Once Daily Empagliflozin and Linagliptin Fixed Dose Combination Compared With Linagliptin Plus Placebo in Japanese Type 2 Diabetes Mellitus Patients With Insufficient Glycaemic Control After 16 Weeks Treatment With Once Daily Linagliptin 5 mg.
In Brief
A Phase 3 clinical trial evaluating Linagliptin, Empagliflozin placebo + linagliptin placebo low dose, and 4 other interventions for Diabetes Mellitus, Type 2. Completed, enrolled 275 participants across 40 sites.
Detailed 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
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus, Type 2
CountriesJapan
CollaboratorsEli Lilly and Company
Timeline
Phase 3CompletedFinished
20162017201820192020202120222023202420252026
Enrollment StartMay 2015
First PostedMay 2015
Primary CompletionAug 2016
Study CompletionMar 2017
TodayJul 2026
First PostedMay 25, 2015
Enrollment StartMay 14, 2015
Primary CompletionAug 26, 2016
Study CompletionMar 27, 2017
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 11.1 years ago
Interventions
Linagliptindrug
Empagliflozin placebo + linagliptin placebo low dosedrug
Matching placebo empagliflozin + linagliptin
Empagliflozin + linagliptin low dosedrug
tablet
Linagliptin placebodrug
Matching placebo linagliptin
Empagliflozin + linagliptin high dosedrug
tablet
Empa + lina highdose placebodrug