Safety and Efficacy of Albiglutide in Type 2 Diabetes

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

Conditions: Diabetes Mellitus, Type 2

Treatments: Biological: albiglutide; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00849056

112755

Details and patient eligibility

About

The purpose of this study is to determine the safety, tolerability and efficacy of albiglutide in the treatment of type 2 diabetes.

Enrollment: 310 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• type 2 diabetes
• BMI 20-45kg/m2

Exclusion criteria

• NYHA Class II to IV heart failure
• females who are pregnant, lactating, or less than 6 weeks post-partum

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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310 participants in 2 patient groups, including a placebo group

placebo + pioglitazone (with or without metformin)

Placebo Comparator group

Description:

Placebo albiglutide weekly injection + pioglitazone (with or without metformin)

Treatment:

Drug: placebo

albiglutide + pioglitazone (with or without metformin)

Experimental group

Description:

albiglutide weekly injection + pioglitazone (with or without meformin)

Treatment:

Biological: albiglutide