Albiglutide Versus Placebo in Insulin-treated Subjects With New-onset Type 1 Diabetes Mellitus

PHASE2CompletedINTERVENTIONAL
Enrollment

67

Participants

Timeline

Start Date

October 10, 2014

Primary Completion Date

October 18, 2017

Study Completion Date

October 18, 2017

Conditions
Diabetes Mellitus, Type 1
Interventions
BIOLOGICAL

Albiglutide weekly injection

Albiglutide will be provided as a fixed-dose, fully disposable pen injector system having a prefilled dual chamber glass cartridge. To be self-administered as a subcutaneous (SC) injection in the abdomen, thigh or upper arm region. The pen will deliver either 30 mg of albiglutide, 50 mg of albiglutide in a 0.5-mL injection volume. It may be administered at any time of day without regard to meals. It will be administered once a week on the same day each week

BIOLOGICAL

Placebo weekly injection

Placebo provided as a fixed-dose, fully disposable pen injector system having a prefilled dual chamber glass cartridge. To be self-administered as a SC injection in the abdomen, thigh or upper arm region. It may be administered at any time of day, once a week on the same day each week, without regard to meals.

BIOLOGICAL

Insulin

Commercially available basal/bolus insulin regimen, self administered by the subject, in accordance to the prescription of the physician and as per the package insert

Trial Locations (32)

14033

GSK Investigational Site, Caen

18012

GSK Investigational Site, Granada

20132

GSK Investigational Site, Milan

25198

GSK Investigational Site, Lleida

28006

GSK Investigational Site, Madrid

29010

GSK Investigational Site, Málaga

40225

GSK Investigational Site, Düsseldorf

41014

GSK Investigational Site, Seville

46600

GSK Investigational Site, Alzira/Valencia

59037

GSK Investigational Site, Lille

60590

GSK Investigational Site, Frankfurt am Main

76230

GSK Investigational Site, Bois-Guillaume

80804

GSK Investigational Site, Munich

01307

GSK Investigational Site, Dresden

04100

GSK Investigational Site, Latina

00128

GSK Investigational Site, Roma

08916

GSK Investigational Site, Badalona

08036

GSK Investigational Site, Barcelona

08907

GSK Investigational Site, L'Hospitalet de Llobregat

07010

GSK Investigational Site, Pama de Mallorca

03550

GSK Investigational Site, San Juan (Alicante)

B9 5SS

GSK Investigational Site, Birmingham

BS2 8HW

GSK Investigational Site, Bristol

CF14 4XN

GSK Investigational Site, Cardiff

DL3 6HX

GSK Investigational Site, Darlington

DD1 9SY

GSK Investigational Site, Dundee

DH1 5TW

GSK Investigational Site, Durham

G31 2ER

GSK Investigational Site, Glasgow

L7 8XP

GSK Investigational Site, Liverpool

E1 2AT

GSK Investigational Site, London

NE1 4LP

GSK Investigational Site, Newcastle upon Tyne

S5 7AU

GSK Investigational Site, Sheffield

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY

NCT02284009 - Albiglutide Versus Placebo in Insulin-treated Subjects With New-onset Type 1 Diabetes Mellitus | Biotech Hunter | Biotech Hunter