CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 72 enrolled
Drug / intervention
Dapagliflozin +1 moredrug
Likely dose
Dapagliflozin 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.

Search/NCT02725593
NCT02725593Phase 3Completed

A 24 Week, Multicenter, Randomized, Double-Blind, Parallel Group, Phase 3 Trial With a 28 Week Long Term Safety Extension Period Evaluating the Safety and Efficacy of Dapagliflozin 10 mg in T2DM Patients Aged 10-24 Years

AstraZeneca·interventional·Posted Apr 1, 2016·Updated Feb 23, 2022

In Brief

A Phase 3 clinical trial evaluating Dapagliflozin and Dapagliflozin placebo for Type 2 Diabetes. Completed, enrolled 72 participants across 42 sites in 7 countries.

Detailed Summary

A trial of patients aged 10-24 years with type 2 diabetes mellitus to evaluate the comparative efficacy and safety between dapagliflozin and Placebo.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 2 Diabetes
CountriesHungary, Israel, Mexico, Romania, Russia, United Kingdom, United States

Timeline

Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedApr 1, 2016
Enrollment StartJun 22, 2016
Primary CompletionApr 6, 2020
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 10.3 years ago

Interventions

Dapagliflozindrug

Dapagliflozin 10 mg tablets administered orally once daily, for the 24-week blinded treatment period. Dapagliflozin 10mg tablets administered orally once daily, for the 28-week site and subject blinded long term extension.

Dapagliflozin placebodrug

matching placebo tablets, administered orally once daily, for the 24-week blinded treatment period. Dapagliflozin 10mg tablets administered orally once daily,for the 28-week site and subject blinded long term extension.