Dapagliflozin Evaluation in Patients with Inadequately Controlled Type 1 Diabetes - DEPICT 1

Study identifier:MB102-229

ClinicalTrials.gov identifier:NCT02268214

EudraCT identifier:2013-004674-97

CTIS identifier:N/A

Study Complete

Official Title

A Multicenter, Randomized, Double-Blind, Placebo-controlled, Parallel Group, Phase 3 Study to Evaluate the Efficacy and Safety of Dapagliflozin as an Add-on to Insulin Therapy in Subjects with Type 1 Diabetes Mellitus

Medical condition

Type 1 Diabetes Mellitus

Phase

Phase 3

Healthy volunteers

No

Study drug

Dapagliflozin, Placebo for dapagliflozin

Sex

All

Actual Enrollment

833

Study type

Interventional

Age

18 Years - 75 Years

Date

Study Start Date: 11 Nov 2014
Primary Completion Date: 04 Jan 2017
Study Completion Date: 25 Aug 2017

Study design

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment

Verification:

Verified 01 Mar 2018 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

Bristol-Myers Squibb

Inclusion and exclusion criteria