At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 977 enrolled
Drug / intervention
Empagliflozin +1 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 26 Weeks in Patients With Type 1 Diabetes Mellitus (EASE-3)
In Brief
A Phase 3 clinical trial evaluating Empagliflozin and Placebo for Diabetes Mellitus, Type 1. Completed, enrolled 977 participants across 189 sites in 24 countries.
Detailed Summary
The study will investigate the efficacy, safety, tolerability and Pharmacokinetic(PK) of 3 doses of empagliflozin compared with placebo over 26 weeks in 960 patients with type 1 diabetes mellitus as adjunctive therapy to insulin
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus, Type 1
CountriesAustralia, Canada, Czechia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Mexico, Netherlands, New Zealand, Norway, Poland, Portugal, Romania, Russia, South Africa, Spain, Sweden, United Kingdom, United States
CollaboratorsEli Lilly and Company
Timeline
Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedOct 2015
Enrollment StartDec 2015
Primary CompletionSep 2017
Study CompletionSep 2017
TodayJul 2026
First PostedOct 20, 2015
Enrollment StartDec 22, 2015
Primary CompletionSep 12, 2017
Study CompletionSep 20, 2017
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 10.7 years ago
Interventions
Empagliflozindrug
Placebodrug
For blinding purposes