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

Study Overview
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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.

Official Title
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A Phase 2A, Randomized, Double-Blind, Comparator- and Placebo-Controlled, Multiple-Dose Study to Evaluate the Safety, Tolerability and Efficacy of Two Dose Levels of Mitoglitazone™ in Type 2 Diabetic Patients

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Drug: Placebo
* Drug: Pioglitazone
* Drug: MSDC-0160 90 mg
* Drug: MSDC-0160 220 mg


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Microcrystaline cellulose once daily | Drug: Placebo<br>* Once daily, oral<br>|
| Active Comparator: Pioglitazone<br>Pioglitazone 45 mg once daily | Drug: Pioglitazone<br>* Once daily, oral<br>|
| Experimental: MSDC-0160 90 mg<br>MSDC-0160 90 mg once daily | Drug: MSDC-0160 90 mg<br>* Once daily, oral<br>|
| Experimental: MSDC-0160 220 mg<br>MSDC-0160 220 mg once daily | Drug: MSDC-0160 220 mg<br>* Once daily, oral<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Averaged Postprandial Glucose in Response to a MMT Test | Change from baseline of averaged postprandial glucose (mmol/L) in response to a Mixed-meal tolerance (MMT) test. | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Averaged Insulin Levels in Response to a Mixed-meal Tolerance Test | Change from baseline in averaged post prandial insulin levels in response to a mixed-meal tolerance test. | After four weeks of active therapy | 
| Change From Baseline in FFAs | Change from baseline in Free Fatty Acids (FFAs)following 28 days of active therapy, as part of a lipid profile assessment | After 28 days of active therapy | 
| Change From Baseline in Triglycerides | Change compared to baseline in triglycerides following 28 days of active therapy, as part of a lipid profile assessment | 28 days | 
| Change From Baseline in HDL | Change from baseline in HDL following 28 days of active therapy, as part of a lipid profile assessment | 28 days |