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

Metabolic Solutions

Status and phase: Completed; Phase 2

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: MSDC-0160 220 mg; Drug: Pioglitazone; Drug: MSDC-0160 90 mg; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00760578

MSDC-C003

Details and patient eligibility

About

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

Enrollment: 86 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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86 participants in 4 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Microcrystaline cellulose once daily

Treatment:

Drug: Placebo

Pioglitazone

Active Comparator group

Description:

Pioglitazone 45 mg once daily

Treatment:

Drug: Pioglitazone

MSDC-0160 90 mg

Experimental group

Description:

MSDC-0160 90 mg once daily

Treatment:

Drug: MSDC-0160 90 mg

MSDC-0160 220 mg

Experimental group

Description:

MSDC-0160 220 mg once daily

Treatment:

Drug: MSDC-0160 220 mg