Safety and Efficacy of Saxagliptin in Triple Therapy to Treat Subjects with Type 2 Diabetes

Study identifier:CV181-168

ClinicalTrials.gov identifier:NCT01619059

EudraCT identifier:2011-006323-37

CTIS identifier:N/A

Study Complete

Official Title

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

Medical condition

Type 2 Diabetes

Phase

Phase 3

Healthy volunteers

No

Study drug

Saxagliptin, Dapagliflozin, Dapagliflozin, Metformin IR, Metformin IR, Placebo matching with Saxagliptin

Sex

All

Actual enrollment

315

Study type

Interventional

Age

18 Years +

Date

Study Start Date: 01 Jun 2012
Primary Completion Date: 01 Jun 2014
Study Completion Date: 01 Jan 2015

Study design

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

Verification:

Verified 01 Mar 2016 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria