At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 27 enrolled
Drug / intervention
empagliflozin medium dose +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.
An Open-label, Randomised, Multicentre, Single-dose, Parallel Group Trial to Evaluate Pharmacokinetics and Pharmacodynamics of Empagliflozin in Children and Adolescents From 10 to Less Than 18 Years of Age With Type 2 Diabetes Mellitus
In Brief
A Phase 1 clinical trial evaluating empagliflozin medium dose, empagliflozin high dose, and 1 other intervention for Diabetes Mellitus, Type 2. Completed, enrolled 27 participants across 11 sites in 5 countries.
Detailed Summary
The aim of the study is to generate pharmacokinetic and pharmacodynamic data to identify the safe-effective dose of empagliflozin in children and adolescents aged 10 to less than 18 years with type 2 diabetes mellitus.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus, Type 2
CountriesFrance, Israel, Mexico, South Africa, United States
CollaboratorsEli Lilly and Company
Timeline
Phase 1CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedApr 2014
Enrollment StartJun 2014
Primary CompletionFeb 2016
TodayJul 2026
First PostedApr 23, 2014
Enrollment StartJun 1, 2014
Primary CompletionFeb 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 12.2 years ago
Interventions
empagliflozin medium dosedrug
empagliflozin high dosedrug
empagliflozin low dosedrug