At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 48 enrolled
Drug / intervention
empagliflozin medium dose +3 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 II, Multicentre, Randomized, Double-blind, Placebo-controlled, Parallel Group Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Once Daily, Oral Doses of Empagliflozin as Adjunctive to Insulin Therapy for 28 Days in Japanese Patients With Type 1 Diabetes Mellitus
In Brief
A Phase 2 clinical trial evaluating empagliflozin medium dose, empagliflozin low dose, and 2 other interventions for Diabetes Mellitus, Type 1. Completed, enrolled 48 participants across 4 sites.
Detailed Summary
To assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of once daily oral doses of empagliflozin in Japanese patients with type 1 diabetes mellitus as adjunctive therapy to insulin.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus, Type 1
CountriesJapan
CollaboratorsEli Lilly and Company
Timeline
Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedMar 2016
Enrollment StartMar 2016
Primary CompletionSep 2016
Study CompletionOct 2016
TodayJul 2026
First PostedMar 8, 2016
Enrollment StartMar 20, 2016
Primary CompletionSep 5, 2016
Study CompletionOct 3, 2016
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 10.3 years ago
Interventions
empagliflozin medium dosedrug
empagliflozin low dosedrug
empagliflozin high dosedrug
placebodrug