Dose-Range Finding Study for MK0893 (0893-008)

NCT ID: NCT00479466

Last Updated: 2015-09-09

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

342 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Study Completion Date

2008-05-31

Brief Summary

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A study to compare MK0893 to metformin or placebo for patients with Type 2 diabetes (Diabetes Mellitus).

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

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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MK0893 80 mg

MK0893 tablets totaling 80 mg once daily.

Group Type EXPERIMENTAL

MK0893

Intervention Type DRUG

MK0893 taken orally once daily; 20 mg and 40 mg tablets used in combination according to dose.

Placebo to MK0893

Intervention Type DRUG

Dose-matched placebo tablets to MK0893; taken orally once daily.

Placebo to Metformin

Intervention Type DRUG

Dose-matched placebo tablets to metformin (500 mg); taken orally twice daily.

MK0893 60 mg

MK0893 tablets totaling 60 mg once daily.

Group Type EXPERIMENTAL

MK0893

Intervention Type DRUG

MK0893 taken orally once daily; 20 mg and 40 mg tablets used in combination according to dose.

Placebo to MK0893

Intervention Type DRUG

Dose-matched placebo tablets to MK0893; taken orally once daily.

Placebo to Metformin

Intervention Type DRUG

Dose-matched placebo tablets to metformin (500 mg); taken orally twice daily.

MK0893 40 mg

MK0893 40 mg tablet once daily.

Group Type EXPERIMENTAL

MK0893

Intervention Type DRUG

MK0893 taken orally once daily; 20 mg and 40 mg tablets used in combination according to dose.

Placebo to MK0893

Intervention Type DRUG

Dose-matched placebo tablets to MK0893; taken orally once daily.

Placebo to Metformin

Intervention Type DRUG

Dose-matched placebo tablets to metformin (500 mg); taken orally twice daily.

MK0893 20 mg

MK0893 20 mg tablet once daily.

Group Type EXPERIMENTAL

MK0893

Intervention Type DRUG

MK0893 taken orally once daily; 20 mg and 40 mg tablets used in combination according to dose.

Placebo to MK0893

Intervention Type DRUG

Dose-matched placebo tablets to MK0893; taken orally once daily.

Placebo to Metformin

Intervention Type DRUG

Dose-matched placebo tablets to metformin (500 mg); taken orally twice daily.

Metformin

Metformin HCL 500 mg tablet twice daily BID titrating up to 1000 mg twice daily over 3 weeks.

Group Type ACTIVE_COMPARATOR

Metformin

Intervention Type DRUG

Metformin HCL 500 mg tablet twice daily titrating up to 1000 mg twice daily over 3 weeks.

Placebo to MK0893

Intervention Type DRUG

Dose-matched placebo tablets to MK0893; taken orally once daily.

Placebo

PLA tablets. 12 week treatment period.

Group Type PLACEBO_COMPARATOR

Placebo to MK0893

Intervention Type DRUG

Dose-matched placebo tablets to MK0893; taken orally once daily.

Placebo to Metformin

Intervention Type DRUG

Dose-matched placebo tablets to metformin (500 mg); taken orally twice daily.

Interventions

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MK0893

MK0893 taken orally once daily; 20 mg and 40 mg tablets used in combination according to dose.

Intervention Type DRUG

Metformin

Metformin HCL 500 mg tablet twice daily titrating up to 1000 mg twice daily over 3 weeks.

Intervention Type DRUG

Placebo to MK0893

Dose-matched placebo tablets to MK0893; taken orally once daily.

Intervention Type DRUG

Placebo to Metformin

Dose-matched placebo tablets to metformin (500 mg); taken orally twice daily.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients who have Type 2 Diabetes Mellitus, with suboptimal glucose control, while either not on AHA (antihyperglycemic agent) therapy or on monotherapy or on low-dose combination therapy

Exclusion Criteria

* Patients have a history of Type 1 Diabetes Mellitus
* Patients taking insulin or thiazolidinedione (TZD, a peroxisome proliferator-activated receptor \[PPAR\]-gamma agonist)
* Patients who have a contraindication to metformin
Minimum Eligible Age

21 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Other Identifiers

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2007_526

Identifier Type: -

Identifier Source: secondary_id

0893-008

Identifier Type: -

Identifier Source: org_study_id

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