Safety and Efficacy Study of Albiglutide in Type 2 Diabetes

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

Conditions: Diabetes Mellitus, Type 2

Treatments: Biological: albiglutide; Biological: placebo; Biological: albiglutide uptitration

Study type: Interventional

Funder types: Industry

Identifiers

NCT00849017

112756

Details and patient eligibility

About

The purpose of this study is to determine whether albiglutide is effective in the treament of patients with type 2 diabetes.

Enrollment: 309 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• type 2 diabetes
• BMI 20-45kg/m2 inclusive

Exclusion criteria

• females who are pregnant, lactating, or <6 weeks post-partum
• CHF NYHA class III-IV

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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309 participants in 3 patient groups, including a placebo group

albiglutide

Experimental group

Description:

albiglutide weekly injection

Treatment:

Biological: albiglutide

placebo

Placebo Comparator group

Description:

albiglutide matching placebo

Treatment:

Biological: placebo

albiglutide up-titration

Experimental group

Description:

albiglutide weekly injection uptitration at week 12

Treatment:

Biological: albiglutide uptitration