drugset

drugset / Trial / NCT02725593

Study to Evaluate Safety and Efficacy of Dapagliflozin in Patients With Type 2 Diabetes Mellitus Aged 10-24 Years

NCT02725593 ↗

Phase 3 Completed 72 enrolled AstraZeneca Covance · collab PRA Health Sciences · collab Parexel · collab Q2 Solutions · collab

RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start: 2016-06-22
Primary completion: 2020-04-06
Completion: 2020-04-06

Outcome

Missed primary endpoint

paper The primary outcome of change in HbA1c concentration was not significant in the intention-to-treat analysis PMID 35378069 ↗

Publications

Tamborlane WV, Laffel LM, Shehadeh N, Isganaitis E, Van Name M, Ratnayake J, Karlsson C, Norjavaara E. Efficacy and safety of dapagliflozin in children and young adults with type 2 diabetes: a prospective, multicentre, randomised, parallel group, phase 3 study. Lancet Diabetes Endocrinol. 2022 May;10(5):341-350. doi: 10.1016/S2213-8587(22)00052-3. Epub 2022 Apr 1.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Dapagliflozin	Small molecule	10 mg	Oral

Indications