At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 129 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 Randomised, Double-blind, Placebo-controlled, Parallel Group, 52 Weeks Phase IV Trial to Evaluate Efficacy and Safety of Oral, Once Daily Empagliflozin in Elderly Japanese Patients With Type 2 Diabetes Mellitus and Insufficient Glycaemic Control
In Brief
A Phase 4 clinical trial evaluating Empagliflozin and Placebo for Diabetes Mellitus, Type 2. Completed, enrolled 129 participants across 18 sites.
Detailed Summary
This study is to assess the efficacy of empagliflozin 10 mg after 52 weeks compared to placebo in elderly patients with Type 2 diabetes mellitus (T2DM) and to explore if empagliflozin has any impact on patient physical condition compared to placebo in elderly patients with T2DM.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus, Type 2
CountriesJapan
Collaborators--
Timeline
Phase 4CompletedFinished
202120222023202420252026
First PostedAug 2020
Enrollment StartOct 2020
Primary CompletionAug 2022
Study CompletionAug 2022
TodayJul 2026
First PostedAug 28, 2020
Enrollment StartOct 5, 2020
Primary CompletionAug 19, 2022
Study CompletionAug 26, 2022
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 5.8 years ago
Interventions
Empagliflozindrug
Empagliflozin
Placebodrug
Placebo