Study Of GW823093 In Japanese Subjects With Type 2 Diabetes Mellitus

NCT ID: NCT00372957

Last Updated: 2018-09-04

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-03-22

Study Completion Date

2006-06-28

Brief Summary

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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

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Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Study Groups

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Placebo

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.

Group Type PLACEBO_COMPARATOR

GW823093 placebo capsule

Intervention Type DRUG

Matching placebo of GW823093 capsule or 15mg capsule

GW823093C 15 mg

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.

Group Type EXPERIMENTAL

GW823093 15mg

Intervention Type DRUG

White opaque capsule containing 15mg of GW823093 as free base

GW823093 placebo capsule

Intervention Type DRUG

Matching placebo of GW823093 capsule or 15mg capsule

GW823093C 30 mg

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.

Group Type EXPERIMENTAL

GW823093 30mg

Intervention Type DRUG

White opaque capsule containing 15mg of GW823093 as free base

Interventions

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GW823093 15mg

White opaque capsule containing 15mg of GW823093 as free base

Intervention Type DRUG

GW823093 placebo capsule

Matching placebo of GW823093 capsule or 15mg capsule

Intervention Type DRUG

GW823093 30mg

White opaque capsule containing 15mg of GW823093 as free base

Intervention Type DRUG

Other Intervention Names

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GW823093

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

, ,

Site Status

Countries

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Other Identifiers

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DPB106653

Identifier Type: -

Identifier Source: org_study_id

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