A Monotherapy Study to Evaluate the Efficacy and Safety of 2 Dose Levels of Albiglutide in Japanese Subjects With Type 2 Diabetes Mellitus (T2DM)

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Albiglutide 50 mg weekly; Drug: Liraglutide 0.9 mg daily; Drug: Placebo; Drug: Albiglutide 30 mg weekly

Study type: Interventional

Funder types: Industry

Identifiers

NCT01733758

113121

Details and patient eligibility

About

This study is designed to examine the efficacy and safety of 2 dose levels of weekly subcutaneously injected albiglutide compared with placebo and an open label reference arm of daily subcutaneous injections of liraglutide, in Japanese subjects with Type 2 diabetes mellitus.

Enrollment: 494 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects with diagnosis of Type 2 Diabetes Mellitus, treated with diet and exercise or a stable dose of 1 OAD at screening
• Body mass index (BMI) 17 to 40 kg/ m^2 inclusive
• Subjects who are OAD naïve, HbA1c between 7.0% and 10.0% at Screening and at Visit 2; for subjects who enter the study with 1 OAD, HbA1c between 6.5% and 9.5% at Screening and HbA1c between 7.0% and 10.0% at Visit 2
• 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 TZD or GLP-1R agonist within 4 months before Screening

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

494 participants in 4 patient groups, including a placebo group

Albiglutide 30 mg weekly

Experimental group

Description:

Subjects will be randomly assigned to double blind albiglutide 30 mg weekly treatment for 52 weeks

Treatment:

Drug: Albiglutide 30 mg weekly

Drug: Placebo

Albiglutide 50 mg weekly

Experimental group

Description:

Subjects will be randomly assigned to double blind albiglutide 50 mg weekly until Week 52

Treatment:

Drug: Albiglutide 50 mg weekly

Placebo

Placebo Comparator group

Description:

Subjects will be randomly assigned to double blind matching albiglutide placebo administered weekly. Subjects will then cross-over to double-blind treatment with albiglutide 30 mg weekly at Week 24 until Week 52

Treatment:

Drug: Placebo

Liraglutide 0.9 mg daily

Active Comparator group

Description:

Subjects will be randomly assigned to open-label liraglutide for 52 weeks

Treatment:

Drug: Liraglutide 0.9 mg daily