A Study to Determine the Safety and Efficacy of Albiglutide in Patients With Type 2 Diabetes

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: insulin glargine; Biological: albiglutide

Study type: Interventional

Funder types: Industry

Identifiers

NCT00838916

112754

Details and patient eligibility

About

A study to determine the safety and efficacy of albiglutide in subjects with type 2 diabetes.

Enrollment: 779 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 within <6 weeks post-partum
• current symptomatic heart failure (NYHA Class III-IV)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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779 participants in 2 patient groups

albiglutide weekly injection

Experimental group

Description:

albiglutide weekly subcutaneous injection

Treatment:

Biological: albiglutide

insulin glargine

Active Comparator group

Description:

insulin glargine daily injection

Treatment:

Drug: insulin glargine