Evaluate the Efficacy and Safety of Saxagliptin in combination with Metformin IR compared to Saxagliptin Monotherapy and to Metformin IR Monotherapy in drug naive Chinese subjects with Type 2 Diabetes who have inadequate Glycaemic Control

Study identifier:D1680C00009

ClinicalTrials.gov identifier:NCT02273050

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Multicenter, Randomized, Double-Blind, Active-Controlled, Phase 3 Trial to Evaluate the Efficacy and Safety of Saxagliptin in Combination with Metformin IR as Initial Therapy Compared to Saxagliptin Monotherapy and to Metformin IR Monotherapy in Subjects with Type 2 Diabetes who have Inadequate Glycaemic Control

Medical condition

Type 2 Diabetes Mellitus

Phase

Phase 3

Healthy volunteers

No

Study drug

Saxagliptin 5 mg, Placebo 5 mg for Saxagliptin, Placebo 500 mg for metformin (with titration), Metformin 500 mg with titration

Sex

All

Actual Enrollment

1136

Study type

Interventional

Age

18 Years - 100 Years

Date

Study Start Date: 01 Dec 2014
Primary Completion Date: 01 Aug 2016
Study Completion Date: 01 Aug 2016

Study design

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

Verification:

Verified 01 Aug 2017 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria