A Study to Determine the Long Term Safety and Efficacy of Albiglutide in Combination With Oral Monotherapy Antihyperglycemic Medications in Japanese Patients With Type 2 Diabetes Mellitus

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

Conditions: Diabetes Mellitus

Treatments: Drug: Sulfonylurea; Drug: Thiazolidinedione; Drug: Glinide; Drug: Biguanide; Drug: Albiglutide; Drug: Alpha-glucosidase inhibitor

Study type: Interventional

Funder types: Industry

Identifiers

NCT01777282

116170

Details and patient eligibility

About

This study is designed to examine the long term safety and efficacy of weekly subcutaneously injected albiglutide in combination with a single oral antidiabetic drug for 52 weeks in Japanese subjects with type 2 diabetes mellitus.

Full description

This study is designed to examine the long term safety and efficacy of weekly subcutaneously injected albiglutide in combination with a single oral antidiabetic drug for 52 weeks in Japanese subjects with type 2 diabetes mellitus. Subjects with a historical diagnosis of type 2 diabetes mellitus who are inadequately controlled on a single oral antidiabetic agent will be recruited into the study. Subjects will continue on their single antidiabetic agent and once weekly albiglutide will be added.

Enrollment: 374 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects with diagnosis of Type 2 Diabetes Mellitus, who are experiencing inadequate glycemic control and receiving treatment with a stable dose of a single oral antidiabetic medication
• Body mass index (BMI) 17 to 40 kg/ m2 inclusive
• Subjects with an HbA1c between 7.0% and 10.0% at Screening
• Creatinine clearance >30 mL/min (calculated using the Cockcroft-Gault formula)

Exclusion criteria

• History of type 1 diabetes mellitus
• Female subject is pregnant, lactating, or <6 weeks postpartum
• Clinically significant cardiovascular and/or cerebrovascular disease
• Current ongoing symptomatic biliary disease, clinical signs or symptoms of pancreatitis, or a history of chronic or acute pancreatitis, as determined by the investigator
• Serum amylase >=3 ×ULN and/or serum lipase >=2 × ULN and/or subject is experiencing any symptoms possibly related to pancreatitis
• Prior use of a GLP-1R agonist or DPP-IV inhibitor within 6 months before Screening

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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374 participants in 5 patient groups

Albiglutide + Sulfonylurea

Active Comparator group

Description:

Albiglutide in combination with background sulfonylurea

Treatment:

Drug: Albiglutide

Drug: Sulfonylurea

Albiglutide + Biguanide

Active Comparator group

Description:

Albiglutide in combination with background biguanide

Treatment:

Drug: Biguanide

Drug: Albiglutide

Albiglutide + Glinide

Active Comparator group

Description:

Albiglutide in combination with background glinide

Treatment:

Drug: Glinide

Drug: Albiglutide

Albiglutide + Thiazolidinedione

Active Comparator group

Description:

Albiglutide in combination with background thiazolidinedione

Treatment:

Drug: Thiazolidinedione

Drug: Albiglutide

Albiglutide + Alpha-glucosidase inhibitor

Active Comparator group

Description:

Albiglutide in combination with background alpha-glucosidase inhibitor

Treatment:

Drug: Albiglutide

Drug: Alpha-glucosidase inhibitor