At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 730 enrolled
Drug / intervention
Empagliflozin +2 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, Placebo-controlled, Parallel Group, Efficacy, Safety and Tolerability Trial of Once Daily, Oral Doses of Empagliflozin as Adjunctive to inSulin thErapy Over 52 Weeks in Patients With Type 1 Diabetes Mellitus (EASE-2)
In Brief
A Phase 3 clinical trial evaluating Empagliflozin and Placebo for Diabetes Mellitus, Type 1. Completed, enrolled 730 participants across 131 sites in 17 countries.
Detailed Summary
Comparison of 2 doses of empagliflozin vs placebo in patients already using either an insulin regimen of multiple daily injections (MDI) or continuous subcutaneous insulin infusion (CSII). Randomisation to 3 treatments arms (equal assignment) following a screening period, an optimisation period and a run-in period. 52 week double-blind treatment period, and 3 week follow-up period.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus, Type 1
CountriesAustralia, Austria, Belgium, Canada, Czechia, Denmark, Finland, France, Germany, Netherlands, Norway, Poland, Spain, Sweden, Taiwan, United Kingdom, United States
CollaboratorsEli Lilly and Company
Timeline
Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedApr 2015
Enrollment StartJun 2015
Primary CompletionApr 2017
Study CompletionOct 2017
TodayJul 2026
First PostedApr 13, 2015
Enrollment StartJun 30, 2015
Primary CompletionApr 20, 2017
Study CompletionOct 23, 2017
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 11.2 years ago
Interventions
Empagliflozindrug
Empagliflozindrug
Placebodrug