A 24-week Open-Label, Phase 3b Trial With a 28-week Extension to Evaluate the Efficacy and Safety of Saxagliptin Co-administered With Dapagliflozin Compared to Insulin Glargine in Subjects withType 2 Diabetes Who Have Glycemic Control on Metformin

PHASE3CompletedINTERVENTIONAL
Enrollment

650

Participants

Timeline

Start Date

October 20, 2015

Primary Completion Date

May 8, 2017

Study Completion Date

November 10, 2017

Conditions
Type 2 Diabetes Mellitus
Interventions
DRUG

Saxagliptin, Onglyza

Tablets, Oral, 5mg , Once daily, 24 weeks

DRUG

Dapagliflozin, Farxiga

Tablets, Oral, 10mg , Once daily, 24 weeks

DRUG

Glargine insulin

100 Units/ml solution for injection in a prefilled SoloStar pen

DRUG

Metformin

Tablets, Oral, ≥ 1500mg/≤ 2500mg, Once daily, 24 weeks

Trial Locations (40)

1032

Research Site, Budapest

1097

Research Site, Budapest

1171

Research Site, Budapest

1827

Research Site, Lenasia

2400

Research Site, Copenhagen

15006

Research Site, A Coruña

19504

Research Site, Barto

29204

Research Site, Columbia

30071

Research Site, Norcross

33144

Research Site, Miami

33155

Research Site, Miami

33709

Research Site, St. Petersburg

37620

Research Site, Bristol

37660

Research Site, Kingsport

40502

Research Site, Lexington

44670

Research Site, Guadalajara

45200

Research Site, Zapopan, Jalisco

45432

Research Site, Beavercreek

60612

Research Site, Chicago

64460

Research Site, Monterrey

73069

Research Site, Norman

74194

Research Site, Mesquite

77004

Research Site, Houston

78230

Research Site, San Antonio

78258

Research Site, San Antonio

84010

Research Site, Bountiful

90057

Research Site, Los Angeles

92801

Research Site, Anaheim

100018

Research Site, Ploieşti

200349

Research Site, Craiova

300125

Research Site, Timișoara

300456

Research Site, Timișoara

02169

Research Site, Quincy

360 01

Research Site, Karlovy Vary

772 00

Research Site, Olomouc

03800

Research Site, México

92-003

Research Site, Lodz

09-505

Research Site, Nowy Duninów

96-500

Research Site, Sochaczew

451 80

Research Site, Uddevalla

Sponsors

Lead Sponsor

All Listed Sponsors
lead

AstraZeneca

INDUSTRY