Efficacy and Safety of Albiglutide in Treatment of Type 2 Diabetes

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: placebo sitagliptin; Drug: placebo glimepiride; Biological: albiglutide; Biological: placebo albiglutide; Drug: glimepiride; Drug: sitagliptin; Drug: metformin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00838903

112753

Details and patient eligibility

About

The purpose of this study is to determine if albiglutide is safe and effective in the treatment of type 2 diabetes.

Enrollment: 1,049 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
• current symptomatic heart failure (NYHA Class III or IV)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,049 participants in 4 patient groups

albiglutide + metformin

Experimental group

Description:

Albiglutide + metformin + placebo sitagliptin + placebo glimepiride

Treatment:

Biological: albiglutide

Drug: placebo glimepiride

Drug: placebo sitagliptin

Drug: metformin

sitagliptin + metformin

Active Comparator group

Description:

Sitagliptin + metformin + placebo albiglutide + placebo glimepiride

Treatment:

Drug: placebo glimepiride

Drug: metformin

Biological: placebo albiglutide

Drug: sitagliptin

glimepiride + metformin

Active Comparator group

Description:

Glimepiride + metformin + placebo albiglutide + placebo sitagliptin

Treatment:

Drug: placebo sitagliptin

Drug: metformin

Drug: glimepiride

Biological: placebo albiglutide

metformin + placebo

Active Comparator group

Description:

Metformin + placebo albiglutide + placebo sitagliptin + placebo glimepiride

Treatment:

Drug: placebo glimepiride

Drug: placebo sitagliptin

Drug: metformin

Biological: placebo albiglutide