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

PHASE3CompletedINTERVENTIONAL
Enrollment

1,136

Participants

Timeline

Start Date

December 31, 2014

Primary Completion Date

August 31, 2016

Study Completion Date

August 31, 2016

Conditions
Type 2 Diabetes Mellitus
Interventions
DRUG

Saxagliptin 5 mg

Tablet, Oral, 5 mg, Once daily in the morning

DRUG

Placebo 5 mg for Saxagliptin

Tablet, Oral, 5 mg, Once daily in the morning

DRUG

Placebo 500 mg for metformin (with titration)

Tablet, 500 mg, Once daily in the evening the first two weeks and thereafter according to titration.

DRUG

Metformin 500 mg with titration

Tablet, 500 mg, Once daily in the evening the first two weeks and thereafter according to titration.

Trial Locations (17)

Unknown

Research Site, Beijing

Research Site, Changchun

Research Site, Chuangchun

Research Site, Fuzhou

Research Site, Guiyang

Research Site, Hangzhou

Research Site, Ha’erbin

Research Site, Hefei

Research Site, Jinan

Research Site, Nanchang

Research Site, Nanjing

Research Site, Shanghai

Research Site, Shijiazhuang

Research Site, Siping

Research Site, Tianjin

Research Site, Wuxi

Research Site, Yueyang

Sponsors

Lead Sponsor

All Listed Sponsors
lead

AstraZeneca

INDUSTRY