Safety and Efficacy of Saxagliptin Plus Insulin With or Without Metformin

PHASE3CompletedINTERVENTIONAL
Enrollment

455

Participants

Timeline

Start Date

November 30, 2008

Primary Completion Date

April 30, 2010

Study Completion Date

April 30, 2010

Conditions
Type 2 Diabetes
Interventions
DRUG

Saxagliptin, 5 mg + insulin

Saxagliptin, 5-mg tablets (plus stable insulin dose), given orally once daily (24 weeks short-term, 28 weeks long-term); participants stratified by use of stable metformin dose; flexible insulin dose (as needed for rescue)

DRUG

Placebo + insulin

Placebo tablets given orally once daily for 24 weeks (short-term period)+ insulin with metformin

Trial Locations (80)

1041

Local Institution, Budapest

1083

Local Institution, Budapest

1212

Local Institution, Budapest

2193

Local Institution, Parktown

4001

Local Institution, Durban

4319

Local Institution, Umhlanga

6600

Local Institution, Szentes

7460

Local Institution, Goodwood

7505

Local Institution, Tygerberg

8230

Local Institution, Balatonfüred

8900

Local Institution, Zalaegerszeg-Pozva

14000

Local Institution, Mexico City

14224

Southgate Medical Group, West Seneca

20127

Local Institution, Aguascalientes

20230

Local Institution, Aguascalientes

25030

Local Institution, Besançon

29687

Southeastern Research Associates, Inc., Taylors

30076

Endocrine Research Solutions, Inc., Roswell

32428

Family Care Associates Of Nw Florida, Chipley

32446

Panhandle Family Care Assoc. & Coastal Palms Res. Grp Inc., Marianna

32701

Central Florida Clinical Trials, Inc., Altamonte Springs

34295

Local Institution, Montpellier

39159

Danny W. Jackson P.A., Rolling Fork

44093

Local Institution, Nantes

45150

Local Institution, Zapopan, Jal.

53209

Aurora Advanced Healthcare, Milwaukee

59300

Local Institution, Valenciennes

64060

Local Institution, Monterrey

64240

Local Institution, Monterrey

64700

Local Institution, Monterrrey

64710

Local Institution, Monterrey

77081

Texas Center For Drug Development, Houston

78229

Dgd Research, Inc., San Antonio

85282

Clinical Research Advantage, Inc, Tempe

90717

Torrance-Lomita Medical Center, Lomita

91325

Diabetes Medical Center Of California, Northridge

91700

Local Institution, Veracruz

91978

Encompass Clinical Research, Spring Valley

92117

Ritchken & First M.D.'S, San Diego

93720

Valley Research, Fresno

132001

Local Institution, Hariyāna

150062

Local Institution, Yaroslaval

191015

Local Institution, Saint Petersburg

194156

Local Institution, Saint Petersburg

195257

Local Institution, Saint Petersburg

197022

Local Institution, Saint Petersburg

198013

Local Institution, Saint Petersburg

214018

Local Institution, Smolensk

305035

Local Institution, Kursk

400007

Local Institution, Mumbai

410031

Local Institution, Saratov

411011

Local Institution, Pune

411037

Local Institution, Pune

452001

Local Institution, Indore

632004

Local Institution, Vellore

T3B 0M3

Local Institution, Calgary

V6E 1M7

Local Institution, Vancouver

E2A 4X7

Local Institution, Bathurst

N6A 4V2

Local Institution, London

C1A 5Y9

Local Institution, Charlottetown

J8V 2P5

Local Institution, Gatineau

H7T 2P5

Local Institution, Laval

J1G 5K2

Local Institution, Sherbrooke

S4P 0W5

Local Institution, Regina

411 030

Local Institution, Pune

06700

Local Institution, Mexico City

82-300

Local Institution, Elblag

80-286

Local Institution, Gdansk

30-510

Local Institution, Krakow

90-153

Local Institution, Lodz

20-950

Local Institution, Lublin

81-756

Local Institution, Sopot

71-455

Local Institution, Szczecin

50-088

Local Institution, Wroclaw

41-800

Local Institution, Zabrze

TS4 3BW

Local Institution, Middlesbrough

M6 8HD

Local Institution, Salford

NE4 6BE

Local Institution, Newcastle upon Tyne

B9 5SS

Local Institution, Birmingham

S5 7AU

Local Institution, Sheffield

Sponsors

Lead Sponsor

All Listed Sponsors
lead

AstraZeneca

INDUSTRY