Conditions: Diabetes Mellitus, Type 2
Keywords: open-label albiglutide insulin glargine preprandial insulin
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 586
Healthy volunteers: no

Brief summary:
This study will examine the safety and efficacy of albiglutide in combination with insulin glargine as compared with the combination of insulin glargine and preprandial lispro insulin in subjects with type 2 diabetes.

Detailed description:
This randomized, open-label, active-controlled, parallel-group, multicenter study evaluates the safety and efficacy of a weekly subcutaneously injected dose of albiglutide in combination with insulin glargine as compared with the combination of insulin glargine and preprandial lispro insulin in subjects with type 2 diabetes. Subjects with a historical diagnosis of type 2 diabetes who are inadequately controlled despite the use of insulin glargine or other intermediate- or long-acting insulins for \>/= 6 months but \< 5 years, with or without oral antidiabetic medications, who are unable to achieve a glycosylated hemoglobin value of \< 7% will be recruited into the study. Subjects must also be willing and capable of pursuing an intensive regimen of both basal and preprandial insulin.

Arms:
arm 1: albiglutide in combination with insulin glargine arm 2: insulin glargine in combination with preprandial lispro insulin

Interventions: intervention 1: albiglutide + insulin glargine intervention 2: insulin glargine + preprandial lispro insulin
Intervention descriptions: intervention 1: albiglutide in combination with insulin glargine intervention 2: insulin glargine in combination with preprandial lispro insulin

Protocol document: