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Completed

NCT Number: NCT00760578

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

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

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Los Angeles, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Placebo

Drug

Once daily, oral

pioglitazone

Drug

Once daily, oral

MSDC-0160 90 mg

Drug

Once daily, oral

MSDC-0160 220 mg

Drug

Once daily, oral

Primary outcomes

  1. 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 outcomes

  1. 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.

  2. 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

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

Metabolic Solutions Development Company

Industry

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Sep 26, 2008
Registry last updated
May 3, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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