Diabetes Mellitus, Type 2 Clinical Trial
Official title:
A Multicenter, Two Part, Randomized, Parallel Group, Placebo and Sitagliptin Controlled Study to Evaluate the Safety and Efficacy of GSK256073 Administered Once or Twice Daily for 12 Weeks in Subjects With Type 2 Diabetes Mellitus Who Are Being Treated With Metformin
The aim of this combined, two part study is to evaluate the safety and glucose lowering effects of GSK256073 when administered to diabetic subjects for 12 weeks.
The study will be conducted at centers in Europe and the United States. The study is being
conducted in two parts. Part A (n = 90 subjects) will provide a preliminary evaluation of 12
weeks of treatment. Initiation of part B (n = 210 additional subjects) will be dependent on
the results observed in part A. The emerging data from part A will be used to guide selection
of the doses in Part B. Up to 8 dose levels of GSK256073 may be included in part B. The
emerging exposure response relationships from the part A interim analysis will be used to
guide dose selection.
Each subject enrolled in the study will undergo screening procedures, a 2 week placebo run-in
period, baseline assessments, randomization, a twelve week treatment period, and a 2 week
follow-up period. Following completion of the baseline visit and randomization into the
study, subjects will return to the clinic for safety and efficacy assessments at Weeks 3, 6,
9, and 12. A subject's total participation in the study will last up to approximately 20
weeks. Subjects will continue their current prescribed regimen of metformin (glucophage)
monotherapy and will monitor fasting blood glucose levels daily using a glucometer.
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