Study to Evaluate the Efficacy and Safety of Saxagliptin Co-administered with Dapagliflozin in Combination with Metformin Compared to Sitagliptin in Combination with Metformin in Adult Patients with Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Therapy Alone

Study identifier:CV181-363

ClinicalTrials.gov identifier:NCT02284893

EudraCT identifier:2014-001102-17

CTIS identifier:N/A

Study Complete

Official Title

A 26-week International, Multicenter, Randomized, Double-Blind, Active Controlled, Parallel Group, Phase 3bTrial with a Blinded 26-week Long -term Extension Period to Evaluate the Efficacy and Safety of Saxagliptin Co-administered with Dapagliflozin in Combination with Metformin Compared to Sitagliptin in Combination with Metformin in Adult Patients with Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Therapy Alone

Medical condition

Type 2 Diabetes

Phase

Phase 3

Healthy volunteers

No

Study drug

Saxagliptin, Dapagliflozin, Sitagliptin, Placebo matching with Saxagliptin, Placebo matching with Dapagliflozin, Placebo matching with Sitagliptin

Sex

All

Actual Enrollment

461

Study type

Interventional

Age

18 Years - 120 Years

Date

Study Start Date: 09 Sept 2014
Primary Completion Date: 20 Sept 2016
Study Completion Date: 20 Sept 2016

Study design

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

Verification:

Verified 01 May 2018 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria