Safety and Efficacy of Combination Saxagliptin & Dapagliflozin added to Metformin to Treat Subjects with Type 2 Diabetes

Study identifier:CV181-169

ClinicalTrials.gov identifier:NCT01606007

EudraCT identifier:2012-000679-18

CTIS identifier:N/A

Study Complete

Official Title

A Multicenter, Randomized, Double-Blind, Active Controlled, Parallel Group, Phase 3 Trial to Evaluate the Safety and Efficacy of Add-On Therapy with Saxagliptin and Dapagliflozin added to Metformin compared to Add-On Therapy with Saxagliptin in combination with Metformin or Dapagliflozin in combination with Metformin in Subjects with Type 2 Diabetes who have Inadequate Glycemic Control on Metformin Alone.

Medical condition

Type 2 Diabetes

Phase

Phase 3

Healthy volunteers

No

Study drug

Saxagliptin, Saxagliptin, Metformin XR, Metformin XR, Metformin XR, Dapagliflozin, Dapagliflozin, Placebo matching with Dapagliflozin, Placebo matching with Saxagliptin

Sex

All

Actual enrollment

1282

Study type

Interventional

Age

18 Years +

Date

Study Start Date: 01 Jul 2012
Primary Completion Date: 01 Jan 2014
Study Completion Date: 01 Jan 2014

Study design

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

Verification:

Verified 01 Mar 2017 by AstraZeneca Pharmaceuticals

Sponsors

AstraZeneca Pharmaceuticals

Collaborators

Astra Zeneca

Inclusion and exclusion criteria