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

Phase 2

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: Placebo; Drug: MSDC-0160 220 mg; Drug: Pioglitazone; Drug: MSDC-0160 90 mg

• Registration Number: NCT00760578
• Lead Sponsor: Metabolic Solutions Development Company

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09
• Study First Submitted: 2008-09-25
• Study First Submitted QC: 2008-09-25
• Study First Posted: 2008-09-26
• Primary Completion: 2009-01
• Study Completion: 2009-02
• Status Verified: 2013-03
• Results First Submitted: 2013-03-19
• Results First Submitted QC: 2013-03-19
• Last Update Submitted: 2013-03-19
• Results First Posted: 2013-05-03
• Last Update Posted: 2013-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 86

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Microcrystaline cellulose once daily
MSDC-0160 220 mg	MSDC-0160 220 mg	MSDC-0160 220 mg once daily
Pioglitazone	Pioglitazone	Pioglitazone 45 mg once daily
MSDC-0160 90 mg	MSDC-0160 90 mg	MSDC-0160 90 mg once daily

Primary Outcome Measures

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

Secondary Outcome Measures

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