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

• Status: Completed
• Trial end date: 2015-01-27
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: 2,4-thiazolidinedione; Biguanides; Glucagon-Like Peptide 1; Glycoside Hydrolase Inhibitors; Hypoglycemic Agents; rGLP-1 protein

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