Conditions: Diabetes Mellitus, Type 2
Keywords: pharmacodynamics Diabetes pharmacokinetics
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 30
Healthy volunteers: no

Brief summary:
To investigate the preliminary pharmacokinetics, pharmacodynamics, safety and tolerability of GW823093 at doses of 15mg and 30mg given once daily for 7 days in Japanese Type 2 diabetes mellitus (T2DM) patients.

Detailed description:

Arms:
arm 1: Participants received two capsules of matching placebo orally once daily in the morning with 150 milliliter (mL) of water at least 15 minutes prior to breakfast for 7 Days. arm 2: Participants received one 15 milligrams (mg) of GW823093C capsule and one placebo capsule orally once daily in the morning with 150 mL of water at least 15 minutes prior to breakfast for 7 Days. arm 3: Participants received 30 mg (2x15 mg) of GW823093C capsules orally once daily in the morning with 150 mL of water at least 15 minutes prior to breakfast for 7 Days.

Interventions: intervention 1: GW823093 15mg intervention 2: GW823093 placebo capsule intervention 3: GW823093 30mg
Intervention descriptions: intervention 1: White opaque capsule containing 15mg of GW823093 as free base intervention 2: Matching placebo of GW823093 capsule or 15mg capsule intervention 3: White opaque capsule containing 15mg of GW823093 as free base

Protocol document: