Study Of GW823093 In Japanese Subjects With Type 2 Diabetes Mellitus

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 2

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: GW823093 30mg; Drug: GW823093 placebo capsule; Drug: GW823093 15mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT00372957

DPB106653

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 20 to 64 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• T2DM diagnosed at least 3 months prior to Screening and fasting plasma glucose (FPG) level <280mg/dL at the Screening visit.
• Concurrent T2DM therapy: Must be diet controlled - OR - not taking more than 2 oral anti-diabetic agents, and willing to withdraw from these treatments 2 weeks prior to the first dosing.

Exclusion criteria

• Must not have any other major illness other than diabetes

Trial design

30 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: GW823093 placebo capsule

GW823093C 15 mg

Experimental group

Description:

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.

Treatment:

Drug: GW823093 15mg

Drug: GW823093 placebo capsule

GW823093C 30 mg

Experimental group

Description:

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.

Treatment:

Drug: GW823093 30mg