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

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: placebo to match albiglutide; Drug: glimepiride; Drug: pioglitazone; Drug: metformin; Biological: albiglutide; Drug: placebo to match pioglitazone

Study type: Interventional

Funder types: Industry

Identifiers

NCT00839527

112757

Details and patient eligibility

About

The purpose of this study is to determine the safety and efficacy of albiglutide in subjects with type 2 diabetes

Enrollment: 685 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 less than 6 weeks post-partum
• current symptomatic heart failure (NYHA Class II-IV)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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685 participants in 3 patient groups

metformin + glimepiride + pioglitazone + albiglutide placebo

Active Comparator group

Description:

Metformin + glimepiride + pioglitazone + matching albiglutide placebo

Treatment:

Drug: placebo to match albiglutide

Drug: pioglitazone

Drug: glimepiride

Drug: metformin

metformin + glimepiride + pioglitazone placebo + albiglutide

Experimental group

Description:

Metformin + open-label glimepiride + pioglitazone matching placebo + albiglutide

Treatment:

Drug: placebo to match pioglitazone

Biological: albiglutide

Drug: glimepiride

Drug: metformin

met + glimepiride + pioglitazone placebo + albiglutide placebo

Active Comparator group

Description:

metformin + open-label glimepiride + pioglitazone placebo + albiglutide placebo

Treatment:

Drug: placebo to match pioglitazone

Drug: placebo to match albiglutide

Drug: glimepiride

Drug: metformin