Study to evaluate safety and efficacy of Dapagliflozin and Saxagliptin in patients with type 2 diabetes mellitus (T2DM) aged 10 to below 18 years old

Study identifier:D1680C00019

ClinicalTrials.gov identifier:NCT03199053

EudraCT identifier:2015-005042-66

CTIS identifier:N/A

Study Complete

Official Title

A 26 Week, Multicenter, Randomized, Placebo-Controlled, Double-Blind, Parallel Group, Phase 3 Trial with a 26 Week Safety Extension Period Evaluating the Safety and Efficacy of Dapagliflozin 5 and 10 mg, and Saxagliptin 2.5 and 5 mg in Pediatric Patients with Type 2 Diabetes Mellitus who are between 10 and below 18 years of age

Medical condition

Diabetes Mellitus, Type 2

Phase

Phase 3

Healthy volunteers

No

Study drug

Dapagliflozin, Saxagliptin, Placebo

Sex

All

Actual Enrollment

256

Study type

Interventional

Age

10 Years - 18 Years

Date

Study Start Date: 11 Oct 2017
Primary Completion Date: 01 Feb 2023
Study Completion Date: 03 Jan 2024

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment

Verification:

Verified 01 May 2024 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria