Conditions: Diabetes Mellitus, Type 2
Keywords: Safety Dose Ranging Efficacy
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 92
Healthy volunteers: no

Brief summary:
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.

Detailed description:
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.

Arms:
arm 1: GSK256073 1mg capsule taken orally twice a day arm 2: GSK256073 2 x 1mg capsule taken orally once a day arm 3: GSK256073 5mg capsule taken orally twice a day arm 4: GSK256073 2 x 5mg capsule taken orally once a day arm 5: GSK256073 10mg capsule taken orally twice a day arm 6: GSK256073 2x 10mg capsule taken orally once a day arm 7: GSK256073 25mg capsule taken orally twice a day arm 8: GSK256073 2x 25mg capsule taken orally once a day arm 9: Matching placebo capsules taken orally either once a day or twice a day arm 10: Commercially available Sitagliptin 100mg capsules taken once a day

Interventions: intervention 1: GSK256073 1mg intervention 2: GSK256073 5mg intervention 3: GSK256073 10mg intervention 4: GSK256073 25mg intervention 5: Placebo intervention 6: Sitagliptin 100mg
Intervention descriptions: intervention 1: GSK256073 1mg capsule intervention 2: GSK256073 5mg capsule intervention 3: GSK256073 10mg capsule intervention 4: GSK256073 25mg capsule intervention 5: placebo capsule intervention 6: Sitagliptin 100mg capsule

Protocol document: