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

This study has been completed.
Information provided by (Responsible Party):
Metabolic Solutions Development Company Identifier:
First received: September 25, 2008
Last updated: March 19, 2013
Last verified: March 2013
The purpose of this study is to determine if MSDC-0160 is effective in the treatment of Type 2 diabetes.

Condition Intervention Phase
Type 2 Diabetes Mellitus
Drug: Placebo
Drug: Pioglitazone
Drug: MSDC-0160 90 mg
Drug: MSDC-0160 220 mg
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Metabolic Solutions Development Company:

Primary Outcome Measures:
  • Change From Baseline in Averaged Postprandial Glucose in Response to a MMT Test [ Time Frame: 28 days ]
    Change from baseline of averaged postprandial glucose (mmol/L) in response to a Mixed-meal tolerance (MMT) test.

Secondary Outcome Measures:
  • Change From Baseline in Averaged Insulin Levels in Response to a Mixed-meal Tolerance Test [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 28 days ]
    Change from baseline in HDL following 28 days of active therapy, as part of a lipid profile assessment

Enrollment: 86
Study Start Date: September 2008
Study Completion Date: February 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Microcrystaline cellulose once daily
Drug: Placebo
Once daily, oral
Active Comparator: Pioglitazone
Pioglitazone 45 mg once daily
Drug: Pioglitazone
Once daily, oral
Experimental: MSDC-0160 90 mg
MSDC-0160 90 mg once daily
Drug: MSDC-0160 90 mg
Once daily, oral
Experimental: MSDC-0160 220 mg
MSDC-0160 220 mg once daily
Drug: MSDC-0160 220 mg
Once daily, oral


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00760578

United States, California
Los Angeles, California, United States
United States, Florida
Miami Gardens, Florida, United States
West Palm Beach, Florida, United States
United States, Michigan
Kalamazoo, Michigan, United States
United States, South Carolina
Greenville, South Carolina, United States
United States, Texas
Dallas, Texas, United States
San Antonio, Texas, United States
United States, Washington
Renton, Washington, United States
Sponsors and Collaborators
Metabolic Solutions Development Company
Study Director: Jerry R Colca, PhD Metabolic Solutions Development Company
  More Information

Responsible Party: Metabolic Solutions Development Company Identifier: NCT00760578     History of Changes
Other Study ID Numbers: MSDC-C003
Study First Received: September 25, 2008
Results First Received: March 19, 2013
Last Updated: March 19, 2013

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hypoglycemic Agents
Physiological Effects of Drugs processed this record on May 23, 2017