At a glance
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A Multidose Study in Subjects With Type 2 Diabetes Mellitus to Assess the Pharmacokinetics and Pharmacodynamics of Albiglutide
In Brief
A Phase 2 clinical trial evaluating albiglutide (GSK716155) for Diabetes Mellitus, Type 2. Completed, enrolled 283 participants across 30 sites.
Detailed Summary
The first part of the study includes a single dose treatment period to evaluate the pharmacokinetic bioequivalence of a subcutaneous injection of albiglutide from process 2 drug substance compared with process 3 drug substance. The second part of the treatment period will evaluate additional pharmacokinetic and pharmacodynamic parameters and safety and tolerability of repeat doses of albiglutide given weekly for 12 weeks from process 2 drug substance compared with process 3 drug substance. Subjects with type 2 diabetes whose glycemia is inadequately controlled on their current regimen of diet and exercise or stable dose of metformin will be recruited into the study.
Study Details
Timeline
Interventions
subcutaneous injection administered once a week
subcutaneous injection administered once a week