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
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Albiglutide; Sulfonylurea; Biguanide; Glinide; Thiazolidinedione; Alpha-glucosidase inhibitor
Intervention description: Albiglutide is a fixed-dose, fully disposable pen injector system for delivery of albiglutide from a prefilled dual chamber glass cartridge that is an integral part of the pen. It is intended for single use by the subject. It is designed for manual reconstitution of the dose, priming, and insertion of the pen needle, and manual injection by the subject. The subject will inject albiglutide 30 mg weekly for 52 weeks (with optional uptitration to 50 mg weekly) subcutaneously into the abdomen, alternating between left and right sides. The pen is designed to work with standard pen needles.; Single oral antidiabetic drug as a background therapy, to be continued as previously prescribed.; Single oral antidiabetic drug as a background therapy, to be continued as previously prescribed.; Single oral antidiabetic drug as a background therapy, to be continued as previously prescribed.; Single oral antidiabetic drug as a background therapy, to be continued as previously prescribed.; Single oral antidiabetic drug as a background therapy, to be continued as previously prescribed.
Intervention MeSH terms: Biguanides; 2,4-thiazolidinedione; Glycoside Hydrolase Inhibitors; rGLP-1 protein
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 374.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: albiglutide; Japanese; glucagon-like peptide-1; GSK716155

Summary:

      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.
    

Eligibility criteria:

        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