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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.
Sponsor:
Information provided by (Responsible Party):
Metabolic Solutions Development Company
ClinicalTrials.gov Identifier:
NCT00760578
First received: September 25, 2008
Last updated: March 19, 2013
Last verified: March 2013
History of Changes
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00760578

Locations
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
Investigators
Study Director: Jerry R Colca, PhD Metabolic Solutions Development Company
  More Information

No publications provided

Responsible Party: Metabolic Solutions Development Company
ClinicalTrials.gov 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
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Pioglitazone
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013