Conditions: Diabetes Mellitus, Type 2
Keywords: Metformin Diabetes
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 16
Healthy volunteers: no

Brief summary:
Metformin may have complex interactions in the gut and is generally first line therapy for type 2 diabetes mellitus (T2DM). It is important to understand whether there are significant pharmacokinetic or pharmacodynamic interactions when GSK2330672 is co-administered with metformin in subjects with T2DM. The purpose of this study is to investigate the safety and tolerability of GSK2330672 administered for 7 days to subjects with T2DM taking metformin. This will be a two-period crossover study; subjects will receive either GSK2330672 or placebo for 7 days in each period separated by a washout period of 13 to 15 days. All subjects will receive metformin throughout the study

Detailed description:

Arms:
arm 1: Subjects will receive metformin 850 mg BID for 7 days, GSK2330672 45 mg BID on Days 1 and 2 and GSK2330672 90 mg BID on Days 3 to 7 in treatment period 1. Subjects will receive metformin 850 mg BID for 7 days, placebo (matching 45 mg GSK2330672) BID on Days 1 and 2 and placebo (matching 90 mg GSK2330672) BID on Days 3 to 7 in treatment period 2. Treatment periods will be separated by a washout period of 13 to 15 days in which subjects will continue metformin 850 mg BID only arm 2: Subjects will receive metformin 850 mg BID for 7 days, placebo (matching 45 mg GSK2330672) BID on Days 1 and 2 and placebo (matching 90 mg GSK2330672) BID on Days 3 to 7 in treatment period 1. Subjects will receive metformin 850 mg BID for 7 days, GSK2330672 45 mg BID on Days 1 and 2 and GSK2330672 90 mg BID on Days 3 to 7 in treatment period 2. Treatment periods will be separated by a washout period of 13 to 15 days in which subjects will continue metformin 850 mg BID only

Interventions: intervention 1: GSK2330672 intervention 2: Placebo intervention 3: Metformin
Intervention descriptions: intervention 1: GSK2330672 will be supplied as oral solution, and will be administered BID \[45 mg (2 days repeat dose) and 90 mg (5 days repeat dose) in each period\] intervention 2: GSK2330672 matching placebo will be supplied as oral solution, and will be administered BID (7 days of dosing in each period) intervention 3: Metformin 850 mg will be administered BID from Run-in period till Day 7 of period 2

Protocol document: