Safety and Efficacy of Dapagliflozin in Asian T2DM Subjects With Inadequate Glycemic Control on Metformin/Saxagliptin

PHASE3TerminatedINTERVENTIONAL
Enrollment

41

Participants

Timeline

Start Date

February 27, 2019

Primary Completion Date

August 4, 2020

Study Completion Date

August 4, 2020

Conditions
Type 2 Diabetes Mellitus
Interventions
DRUG

Dapagliflozin 10 mg

10 mg, oral tablet, once daily for 24 weeks of double-blind treatment period

DRUG

Dapagliflozin 5 mg

5 mg, oral tablet, once daily for 24 weeks of double-blind treatment period

DRUG

Dapagliflozin 10 mg placebo to match

10 mg, oral tablet, once daily for 24 weeks of double-blind treatment period

DRUG

Dapagliflozin 5 mg placebo to match

5 mg, oral tablet, once daily for 24 weeks of double-blind treatment period

DRUG

Saxagliptin 5 mg

5 mg, oral tablet, once daily for 24 weeks of double-blinded treatment period, and for 16 weeks of open-label treatment period in Stratum A or 8 weeks of open-label treatment period in Stratum B

DRUG

Metformin

Stable dose of metformin immediate release/extended release (≥ 1500 mg/day or at a maximal tolerated dose) throughout the whole study period

Trial Locations (4)

10000

Research Site, Ho Chi Minh City

10330

Research Site, Bangkok

10400

Research Site, Bangkok

700000

Research Site, Ho Chi Minh City

Sponsors

Lead Sponsor

All Listed Sponsors
lead

AstraZeneca

INDUSTRY