Glycemic Efficacy and Renal Safety Study of Dapagliflozin in Subjects With Type 2 Diabetes Mellitus and Moderate Renal Impairment

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

631

Participants

Timeline

Start Date

June 30, 2008

Primary Completion Date

December 31, 2009

Study Completion Date

June 30, 2011

Conditions
Diabetes Mellitus, Type 2
Interventions
DRUG

Dapagliflozin

Tablets, Oral, 10 mg, Once Daily, 104 weeks

DRUG

Dapagliflozin

Tablets, Oral, 5 mg, Once Daily, 104 weeks

DRUG

Placebo

Tablets, Oral, 0 mg, Once Daily, 104 weeks

Trial Locations (96)

1

Local Institution, Lima Cercado

18

Local Institution, Lima

2050

Local Institution, Camperdown

2065

Local Institution, St Leonards

2400

Local Institution, Copenhagen Nv

2500

Local Institution, Woollongong

2650

Local Institution, Hvidovre

2800

Local Institution, Zárate

2820

Local Institution, Gentofte Municipality

5000

Local Institution, Córdoba

7250

Local Institution, Launceston

7600

Local Institution, Mar del Plata

10023

Local Institution, Chieri

11501

Winthrop University Hospital, Mineola

11800

Local Institution, Df

13413

Slocum-Dickson Medical Group, Pllc, New Hartford

19102

Drexel University College Of Medicine, Philadelphia

19107

Thomas Jefferson University, Philadelphia

23510

The Strelitz Diabetes Center, Norfolk

25030

Local Institution, Besançon

28702

Local Institution, San Sebastian de Los

29406

Low Country Internal Medicine Of Sc, Pa, Charleston

29485

Palmetto Clinical Research, Summerville

29572

Carolina Health Specialists, Myrtle Beach

29609

Local Institution, Brest

30076

Endocrine Research Solutions, Inc., Roswell

32446

Panhandle Family Care Associates, Marianna

33614

Genesis Clinical Research, Tampa

34075

Local Institution, Durango

35128

Local Institution, Padua

38000

Local Institution, Celaya

41100

Local Institution, Modena

43701

Physician Research, Inc., Zanesville

44122

Center For Thyroid Diseases And Endocrinology, Beachwood

44319

Community Health Care Of Manchester, Akron

44670

Local Institution, Guadalajara

48903

Local Institution, Vizcaya

53100

Local Institution, Siena

53209

Aurora Advanced Healthcare, Milwaukee

53295

Zablocki Veterans Affairs Medical Center, Milwaukee

55430

Twin Cities Clinical Research, Brooklyn Center

56126

Local Institution, Pisa

64128

Kcva Medical Center Research Svc (151), Kansas City

64460

Local Institution, Monterrey

66013

Local Institution, Chieti Scalo

68105

Va Nebraska-Western Iowa Health Care System (Nwihcs), Omaha

73104

Univ Of Oklahoma Health Science Center, Oklahoma City

75231

Research Institute Of Dallas, Dallas

75475

Local Institution, Paris

75877

Local Institution, Paris

77005

Westbury Medical Clinic P.A., Houston

80220

Endocrine Associates Of The Rockies, Denver

85206

Vista Medical Research, Inc., Mesa

86021

Local Institution, Poitiers

90502

La Biomed At Harbor Ucla Med Ctr., Torrance

91325

Diabetes Medical Center Of California, Northridge

92505

Apex Research Of Riverside, Riverside

93720

Valley Research, Fresno

94904

Marin Endocrine Care & Research, Inc., Greenbrae

95032

Office Of Richard Cherlin, Md, Los Gatos

97504

Rogue Valley Clinical Research, Medford

98405

Cedar Research Llc, Tacoma

98502

Capital Clinical Research Center, Olympia

119074

Local Institution, Singapore

411011

Local Institution, Pune, Maharashtra

452001

Local Institution, Indore

560034

Local Institution, Bangalore

600029

Local Institution, Chennai

08043

University Of Medicine And Dentistry Of New Jersey, Voorhees Township

C1012AAR

Local Institution, Buenos Aires

C1408INH

Local Institution, Buenos Aires

C1405BCJ

Local Institution, Capital Federal

X5006CBI

Local Institution, Córdoba

A4406CLA

Local Institution, Salta

T3B 0M3

Local Institution, Calgary

R3E 3P4

Local Institution, Winnipeg

L4M 7G1

Local Institution, Barrie

L4J 8L7

Local Institution, Thornhill

M4N 3M5

Local Institution, Toronto

M4R 2G4

Local Institution, Toronto

J8V 2P5

Local Institution, Gatineau

H7T 2P5

Local Institution, Laval

J1G 5K2

Local Institution, Sherbrooke

S4P 0W5

Local Institution, Regina

411 004

Local Institution, Pune

560 052

Local Institution, Bangalore

302 001

Local Institution, Rajasthan

06126

Local Institution, Perugia

00189

Local Institution, Roma

01120

Local Institution, Df

06700

Local Institution, Df

Unknown

Local Institution, Arequipa

LIMA 13

Local Institution, Lima

00725

Local Institution, Caguas

00909

Local Institution, San Juan

08036

Local Institution, Barcelona

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Bristol-Myers Squibb

INDUSTRY

lead

AstraZeneca

INDUSTRY