Conditions: Diabetes Mellitus, Type 2
Keywords: Tolerability Pharmacokinetics Safety Pharmacodynamics Glucose
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 100
Healthy volunteers: no

Brief summary:
The purpose of this study is to see if GSK1292263 is safe and well-tolerated when administered to type 2 diabetics, and to get preliminary information about whether it may be effective in the treatment of type 2 diabetes.

Detailed description:
Data from this study will be used to assess the potential of GSK1292263 as a treatment for T2DM, and will aid the design and dose selection of future studies of longer duration in T2DM subjects that will evaluate GSK1292263 alone or in combination with other anti-diabetic drugs.

Arms:
arm 1: Part A (Cohort 1) is a single-blind, randomized, placebo-controlled, 5-period crossover in which drug naïve T2DM subjects will receive escalating doses of GSK1292263 in each of 3 periods and placebo and open-label sitagliptin in the other 2 periods. The sequence will be randomized, but will maintain the low, medium and high dose order for GSK1292263. arm 2: Part B (Cohort 2) is a single-blind, randomized, 2-period study in which T2DM subjects will receive a single dose of GSK1292263, fasted or fed. arm 3: Part C (Cohort 3, optional Cohort 4) is a single-blind, randomized, placebo-controlled, 5-arm study of 14 days of dosing with GSK1292263, placebo or open-label sitagliptin. An optional Cohort 4 may be enrolled to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of GSK1292263 when dosed in a BID regimen.

Interventions: intervention 1: GSK1292263 intervention 2: GSK1292263 matching placebo intervention 3: Sitagliptin
Intervention descriptions: intervention 1: GSK1292263 is an immediate-release round, white, film-coated tablet provided in 3 strengths, 25mg, 75mg and 200mg being developed for the treatment of type 2 diabetes. intervention 2: Matching placebo to active drug GSK1292263 intervention 3: Sitagliptin (Januvia) 100mg tablets are beige, round, film-coated tablets with "277" on one side.

Protocol document: