Safety and Efficacy Study of Albiglutide Liquid Drug Product in Type 2 Diabetes Mellitus

PHASE3CompletedINTERVENTIONAL
Enrollment

308

Participants

Timeline

Start Date

March 16, 2016

Primary Completion Date

April 3, 2017

Study Completion Date

May 15, 2017

Conditions
Diabetes Mellitus, Type 2
Interventions
DRUG

Lyophilized albiglutide DCC pen injector

A fixed-dose, fully disposable pen injector system with a prefilled dual chamber glass cartridge (DCC) containing lyophilized albiglutide (30mg or 50mg) delivering an injection volume of 0.5mL.

DRUG

Lyophilized albiglutide DCC pen injector matching placebo

A fixed-dose, fully disposable pen injector system with a prefilled DCC containing matching placebo delivering an injection volume of 0.5mL

DRUG

Albiglutide liquid auto-injector

A fixed-dose, single use, disposable auto-injector containing albiglutide liquid (30mg or 50mg) in a prefilled glass syringe. The auto-injector delivers the albiglutide liquid in an injection volume of 0.6 mL for the 30mg dose and 1.0 mL for the 50mg dose.

DRUG

Albiglutide liquid auto-injector matching placebo

A fixed-dose, single use, disposable auto-injector containing matching placebo in a prefilled glass syringe. The auto-injector delivers the matching placebo in an injection volume of 0.6 mL for the 30mg dose and 1.0 mL for the 50mg dose.

Trial Locations (70)

11042

GSK Investigational Site, New Hyde Park

16602

GSK Investigational Site, Altoona

27405

GSK Investigational Site, Greensboro

28150

GSK Investigational Site, Shelby

29204

GSK Investigational Site, Columbia

29621

GSK Investigational Site, Anderson

30078

GSK Investigational Site, Snellville

30094

GSK Investigational Site, Conyers

32003

GSK Investigational Site, Fleming Island

32825

GSK Investigational Site, Orlando

33009

GSK Investigational Site, Hallandale

33016

GSK Investigational Site, Hialeah

33156

GSK Investigational Site, Miami

33176

GSK Investigational Site, Miami

33709

GSK Investigational Site, St. Petersburg

34208

GSK Investigational Site, Bradenton

34601

GSK Investigational Site, Brooksville

34652

GSK Investigational Site, New Port Richey

35216

GSK Investigational Site, Birmingham

35235

GSK Investigational Site, Birmingham

40503

GSK Investigational Site, Lexington

43201

GSK Investigational Site, Columbus

43551

GSK Investigational Site, Perrysburg

45212

GSK Investigational Site, Norwood

47714

GSK Investigational Site, Evansville

48098

GSK Investigational Site, Troy

49009

GSK Investigational Site, Kalamazoo

60124

GSK Investigational Site, Elgin

60612

GSK Investigational Site, Chicago

63017

GSK Investigational Site, Chesterfield

63141

GSK Investigational Site, St Louis

66606

GSK Investigational Site, Topeka

70119

GSK Investigational Site, New Orleans

70601

GSK Investigational Site, Lake Charles

75230

GSK Investigational Site, Dallas

76012

GSK Investigational Site, Arlington

77051

GSK Investigational Site, Houston

77058

GSK Investigational Site, Houston

77074

GSK Investigational Site, Houston

77079

GSK Investigational Site, Katy

77379

GSK Investigational Site, Spring

78154

GSK Investigational Site, Schertz

78229

GSK Investigational Site, San Antonio

78231

GSK Investigational Site, San Antonio

78577

GSK Investigational Site, Pharr

80128

GSK Investigational Site, Littleton

83642

GSK Investigational Site, Meridian

84123

GSK Investigational Site, Murray

85018

GSK Investigational Site, Phoenix

85224

GSK Investigational Site, Chandler

85306

GSK Investigational Site, Glendale

87102

GSK Investigational Site, Albuquerque

89123

GSK Investigational Site, Las Vegas

90717

GSK Investigational Site, Lomita

91351

GSK Investigational Site, Canyon Country

91405

GSK Investigational Site, Van Nuys

91911

GSK Investigational Site, Chula Vista

91978

GSK Investigational Site, Spring Valley

92056

GSK Investigational Site, Oceanside

92120

GSK Investigational Site, San Diego

92780

GSK Investigational Site, Tustin

92801

GSK Investigational Site, Anaheim

93720

GSK Investigational Site, Fresno

94598

GSK Investigational Site, Walnut Creek

95821

GSK Investigational Site, Sacramento

98003

GSK Investigational Site, Federal Way

98405

GSK Investigational Site, Tacoma

99208

GSK Investigational Site, Spokane

33765-2616

GSK Investigational Site, Clearwater

43537-9402

GSK Investigational Site, Maumee

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY