A Multi-Center, Randomized, Double-Blind, Phase III trial to evaluate the safety and efficacy of Saxagliptin co-administered with Dapagliflozin compared to Saxagliptin or Dapagliflozin all given as add-on therapy to Metformin in subject with Type 2 Diabetes

Study identifier:D1683C00005

ClinicalTrials.gov identifier:NCT02681094

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Multi-Center, Randomized, Double-Blind, Active-Controlled , Parallel Group, Phase III Trial to Evaluate the Safety and Efficacy of Saxagliptin 5mg Co-administered with Dapagliflozin 5mg compared to Saxagliptin 5mg or Dapagliflozin 5mg all given as Add-on Therapy to Metformin inPatients with Type 2 Diabetes who have Inadequate Glycaemic Control on Metformin Alone

Medical condition

Type 2 Diabetes Mellitus

Phase

Phase 3

Healthy volunteers

No

Study drug

Dapagliflozin, Placebo for Dapagliflozin, Saxagliptin, Placebo for Saxagliptin

Sex

All

Actual Enrollment

905

Study type

Interventional

Age

18 Years - 130 Years

Date

Study Start Date: 26 Feb 2016
Primary Completion Date: 15 Jul 2017
Study Completion Date: 15 Jul 2017

Study design

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

Verification:

Verified 01 Sept 2018 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria