Effect of SCH 497079 on Metabolic Parameters and Influence of Race/Ethnic Origin on Therapeutic Response (Study P05338)(COMPLETED)

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-17

Study Completion Date

2008-12-11

Brief Summary

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The purpose of this study is to evaluate the effect of SCH 497079 on metabolic parameters and to determine the influence of race/ethnic origin on therapeutic response.

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Detailed Description

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This study includes two parts, each part includes three consecutive 28-day treatment periods. Part 1 (to be conducted in the United States): each participant will receive the following treatments for 28 days in each of three treatment periods in an order determined by a random code: SCH 497079, or matching placebo, or metformin.

Part 2 (to be conducted in India): this part of the study will be conducted after completion of Part 1 and an analysis indicates a clinically significant decrease in blood glucose in participants with type 2 diabetes mellitus (T2DM) compared to placebo. The same procedures conducted in Part 1 will be conducted in Part 2.

Conditions

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Type 2 Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Treatment sequence 1: SCH 497079 → Placebo → Metformin

Participants received SCH 497079 daily for 4 weeks followed by placebo daily for 4 weeks followed by metformin daily for 4 weeks.

Group Type EXPERIMENTAL

SCH 497079

Intervention Type DRUG

SCH 497079 100 mg capsule, administered orally, once daily for 4 weeks

Placebo

Intervention Type DRUG

Placebo capsules matching SCH 497079, administered orally, once daily for 4 weeks

Metformin

Intervention Type DRUG

Metformin extended release 750 mg, 2 tablets administered orally, once daily for 4 weeks (1500 mg total daily dose)

Treatment sequence 2: Placebo → Metformin → SCH 497079

Participants received placebo daily for 4 weeks followed by metformin daily for 4 weeks followed by SCH 497079 daily for 4 weeks.

Group Type EXPERIMENTAL

SCH 497079

Intervention Type DRUG

SCH 497079 100 mg capsule, administered orally, once daily for 4 weeks

Placebo

Intervention Type DRUG

Placebo capsules matching SCH 497079, administered orally, once daily for 4 weeks

Metformin

Intervention Type DRUG

Metformin extended release 750 mg, 2 tablets administered orally, once daily for 4 weeks (1500 mg total daily dose)

Treatment sequence 3: Metformin → SCH 497079 → Placebo

Participants received metformin daily for 4 weeks followed by SCH 497079 daily for 4 weeks followed by placebo daily for 4 weeks.

Group Type EXPERIMENTAL

SCH 497079

Intervention Type DRUG

SCH 497079 100 mg capsule, administered orally, once daily for 4 weeks

Placebo

Intervention Type DRUG

Placebo capsules matching SCH 497079, administered orally, once daily for 4 weeks

Metformin

Intervention Type DRUG

Metformin extended release 750 mg, 2 tablets administered orally, once daily for 4 weeks (1500 mg total daily dose)

Treatment sequence 4: SCH 497079 → Metformin → Placebo

Participants received SCH 497079 daily for 4 weeks followed by metformin daily for 4 weeks followed by placebo daily for 4 weeks.

Group Type EXPERIMENTAL

SCH 497079

Intervention Type DRUG

SCH 497079 100 mg capsule, administered orally, once daily for 4 weeks

Placebo

Intervention Type DRUG

Placebo capsules matching SCH 497079, administered orally, once daily for 4 weeks

Metformin

Intervention Type DRUG

Metformin extended release 750 mg, 2 tablets administered orally, once daily for 4 weeks (1500 mg total daily dose)

Treatment sequence 5: Placebo → SCH 49709 → Metformin

Participants received placebo daily for 4 weeks followed by SCH 497079 daily for 4 weeks followed by metformin daily for 4 weeks.

Group Type EXPERIMENTAL

SCH 497079

Intervention Type DRUG

SCH 497079 100 mg capsule, administered orally, once daily for 4 weeks

Placebo

Intervention Type DRUG

Placebo capsules matching SCH 497079, administered orally, once daily for 4 weeks

Metformin

Intervention Type DRUG

Metformin extended release 750 mg, 2 tablets administered orally, once daily for 4 weeks (1500 mg total daily dose)

Treatment sequence 6: Metformin → Placebo → SCH 497079

Participants received metformin daily for 4 weeks followed by placebo daily for 4 weeks followed by SCH 497079 daily for 4 weeks.

Group Type EXPERIMENTAL

SCH 497079

Intervention Type DRUG

SCH 497079 100 mg capsule, administered orally, once daily for 4 weeks

Placebo

Intervention Type DRUG

Placebo capsules matching SCH 497079, administered orally, once daily for 4 weeks

Metformin

Intervention Type DRUG

Metformin extended release 750 mg, 2 tablets administered orally, once daily for 4 weeks (1500 mg total daily dose)

Interventions

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SCH 497079

SCH 497079 100 mg capsule, administered orally, once daily for 4 weeks

Intervention Type DRUG

Placebo

Placebo capsules matching SCH 497079, administered orally, once daily for 4 weeks

Intervention Type DRUG

Metformin

Metformin extended release 750 mg, 2 tablets administered orally, once daily for 4 weeks (1500 mg total daily dose)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* \>=18 years of age to 65 years of age, of either sex, and having a body mass index (BMI) between 27 and 35, inclusive (USA participants)
* Clinical laboratory tests (complete blood count, blood chemistry, and urinalysis) within normal limits (excluding glucose and other changes usually associated with diabetes eg, dyslipidemia)
* Type 2 diabetes mellitus

Exclusion Criteria

* Female participants who are premenopausal or are not surgically sterilized. Participants who are pregnant, intend to become pregnant (within 3 months of ending the study), or are breast-feeding.
* Participants who have received insulin therapy within 6 months, prior to Day 1/Period 1 or who require thiazide diuretics, beta-blockers and cyclic hormone therapy.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No