At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 53 enrolled
Drug / intervention
Dapagliflozin +2 moredrug
Likely dose
Dapagliflozin 2.5 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 Randomized, Multi-Center, Parallel Group, Single-Dose, Pharmacokinetics and Pharmacodynamics Study of Dapagliflozin in Children and Adolescents Aged 10 to 17 Years With Type 2 Diabetes Mellitus
In Brief
A Phase 1 clinical trial evaluating Dapagliflozin for Type 2 Diabetes Mellitus. Completed, enrolled 53 participants across 17 sites in 2 countries.
Detailed Summary
The primary purpose of this study is to evaluate the pharmacokinetics (PK) of Dapagliflozin in pediatric subjects with type 2 diabetes mellitus (T2DM)
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 2 Diabetes Mellitus
CountriesMexico, United States
CollaboratorsBristol-Myers Squibb
Timeline
Phase 1CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedFeb 2012
Enrollment StartJul 2012
Primary CompletionSep 2014
TodayJul 2026
First PostedFeb 2, 2012
Enrollment StartJul 1, 2012
Primary CompletionSep 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 14.4 years ago
Interventions
Dapagliflozindrug
Tablet, Oral, 2.5 mg, Single-dose
Dapagliflozindrug
Tablet, Oral, 5 mg, Single-dose
Dapagliflozindrug
Tablet, Oral, 10 mg, Single-dose