At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 144 enrolled
Drug / intervention
Empagliflozin +1 moredrug
Likely dose
Empagliflozin 10 mgfrom 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 IV, Single-center, Randomized, Double-blind, Placebo-controlled, Parallel Group Study on the Effects of Empagliflozin on Left Ventricular Diastolic Function Compared to Usual Care in Individuals With Type 2 Diabetes
In Brief
A Phase 4 clinical trial evaluating Empagliflozin and Placebo for Diabetes Mellitus, Type 2 and Diastolic Dysfunction. Completed, enrolled 144 participants across 1 site.
Detailed Summary
The purpose of the EmDia trial is to compare the effects of empagliflozin with placebo in addition to standard diabetic treatment or dietetic treatment on cardiac diastolic function in patients with type 2 Diabetes mellitus.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus, Type 2, Diastolic Dysfunction
CountriesGermany
CollaboratorsBoehringer Ingelheim
Timeline
Phase 4CompletedFinished
2017201820192020202120222023202420252026
Enrollment StartOct 2016
First PostedOct 2016
Primary CompletionJun 2020
Study CompletionAug 2020
TodayJul 2026
First PostedOct 13, 2016
Enrollment StartOct 10, 2016
Primary CompletionJun 15, 2020
Study CompletionAug 31, 2020
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 9.7 years ago
Interventions
Empagliflozindrug
10 mg per os daily for 12 weeks
Placebodrug
amount of Placebo corresponding to empagliflozin 10 mg per os daily for 12 weeks