12-Week Study of DS-8500a in Subjects With Type 2 Diabetes Mellitus on Metformin

PHASE2CompletedINTERVENTIONAL
Enrollment

298

Participants

Timeline

Start Date

January 31, 2016

Primary Completion Date

January 31, 2017

Study Completion Date

January 31, 2017

Conditions
Type 2 Diabetes Mellitus
Interventions
DRUG

Sitagliptin 100 mg

Two sitagliptin 50 mg tablets, over-encapsulated to provide a once-daily dose of 100 mg, for oral administration

DRUG

DS-8500a 25mg

DS-8500a 25mg tablet for oral administration

DRUG

Placebo Tablet

Placebo matching DS-8500a tablet for oral administration

DRUG

Placebo Capsule

Placebo matching sitagliptin over-capsule for oral administration

Trial Locations (58)

22015

Burke

27103

Winston-Salem

28117

Mooresville

28655

Morgantown

29303

Spartanburg

29407

Charleston

29425

Charleston

29464

Mt. Pleasant

29651

Greer

30331

Atlanta

33009

Hallandale

33026

Pembroke Pines

33126

Miami

33135

Miami

33409

West Palm Beach

35216

Birmingham

43213

Columbus

46123

Avon

46131

Franklin

46140

Greenfield

47725

Evansville

48098

Troy

51503

Council Bluffs

55435

Edina

63090

Washington

68114

Omaha

75024

Plano

75231

Dallas

77036

Houston

78228

San Antonio

78229

San Antonio

78705

Austin

80227

Lakewood

80920

Colorado Springs

83704

Boise

84095

South Jordan

84102

Salt Lake City

84121

Salt Lake City

85282

Tempe

85340

Litchfield Park

91710

Chino

91911

Chula Vista

92103

San Diego

92801

Anaheim

93720

Fresno

94904

Greenbrae

95670

Gold River

97504

Medford

V8V 4A1

Victoria

L6T 0G1

Brampton

N5W 6A2

London

L3Y 5GB

Newmarket

M9V 4B4

Toronto

M9W 4L6

Toronto

J7J 2K8

Mirabel

H4N 2W2

Montreal

G1W 4R4

Québec

J1H 1Z1

Sherbrooke

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Daiichi Sankyo

INDUSTRY