A Placebo Controlled Safety and Efficacy Study of MSDC-0160 in Type 2 Diabetes With Active Comparator

NCT ID: NCT00760578

Last Updated: 2013-05-03

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

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2009-02-28

Brief Summary

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The purpose of this study is to determine if MSDC-0160 is effective in the treatment of Type 2 diabetes.

Detailed Description

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Conditions

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Type 2 Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

Microcrystaline cellulose once daily

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Once daily, oral

Pioglitazone

Pioglitazone 45 mg once daily

Group Type ACTIVE_COMPARATOR

Pioglitazone

Intervention Type DRUG

Once daily, oral

MSDC-0160 90 mg

MSDC-0160 90 mg once daily

Group Type EXPERIMENTAL

MSDC-0160 90 mg

Intervention Type DRUG

Once daily, oral

MSDC-0160 220 mg

MSDC-0160 220 mg once daily

Group Type EXPERIMENTAL

MSDC-0160 220 mg

Intervention Type DRUG

Once daily, oral

Interventions

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Placebo

Once daily, oral

Intervention Type DRUG

Pioglitazone

Once daily, oral

Intervention Type DRUG

MSDC-0160 90 mg

Once daily, oral

Intervention Type DRUG

MSDC-0160 220 mg

Once daily, oral

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of Type 2 Diabetes naive or on metformin
* Male and female (postmenopausal or surgically sterilized), 18 to 70 years of age.

Exclusion Criteria

* Use of diabetes medications other than metformin.
* History of heart failure or previous myocardial infarction.
* Blood pressure great than 160/100 mmHg.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Metabolic Solutions Development Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jerry R Colca, PhD

Role: STUDY_DIRECTOR

Metabolic Solutions Development Company

Locations

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Los Angeles, California, United States

Site Status

Miami Gardens, Florida, United States

Site Status

West Palm Beach, Florida, United States

Site Status

Kalamazoo, Michigan, United States

Site Status

Greenville, South Carolina, United States

Site Status

Dallas, Texas, United States

Site Status

San Antonio, Texas, United States

Site Status

Renton, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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MSDC-C003

Identifier Type: -

Identifier Source: org_study_id

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