Efficacy and Safety of Dapagliflozin and Dapagliflozin plus Saxagliptin in Combination with Metformin in Type 2 Diabetes Patients compared with Sulphonylurea

Study identifier:D1689C00014

ClinicalTrials.gov identifier:NCT02471404

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A 52-Week, Multi-Centre, Randomised, Parallel-Group, Double-Blind, Active Controlled, Phase IV Study to Evaluate the Safety and Efficacy of Dapagliflozin or Dapagliflozin plus Saxagliptin compared with Sulphonylurea all given as Add-on Therapy to Metformin in Adult Patients with Type 2 Diabetes Who Have Inadequate Glycaemic Control on Metformin Monotherapy

Medical condition

Type 2 diabetes mellitus,

Phase

Phase 4

Healthy volunteers

No

Study drug

Dapagliflozin, Dapagliflozin, Saxagliptin, Glimepiride, Placebo for dapagliflozin, Placebo for saxagliptin, Placebo for saxagliptin, Placebo for glimepiride, Placebo for glimepiride

Sex

All

Actual enrollment

939

Study type

Interventional

Age

18 Years - 74 Years

Date

Study Start Date: 21 Sept 2015
Primary Completion Date: 13 Mar 2017
Study Completion Date: 13 Mar 2017

Study design

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

Verification:

Verified 01 Jun 2018 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria