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Study to Evaluate the Safety, Tolerability and Efficacy of Three Dose Levels of Mitoglitazone in Type 2 Diabetic Patients

NCT01103414 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 356

Last updated 2015-04-28

Study results available
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Summary

The purpose of this study is to evaluate the safety, tolerability and efficacy of three dose levels of Mitoglitazone™ (MSDC-0160) in patients with type 2 diabetes.

Conditions

Interventions

DRUG

Mitoglitazone

50 mg capsules, once daily for 84 days

DRUG

Mitoglitazone

Mitoglitazone 100 mg capsules, once daily for 84 days

DRUG

Mitoglitazone

Mitoglitazone 150 mg capsules, once daily for 84 days

DRUG

Pioglitazone

Pioglitazone 45 mg, once daily for 84 days

DRUG

Placebo

Placebo, once daily for 84 days

Sponsors & Collaborators

  • Metabolic Solutions Development Company

    lead INDUSTRY

Principal Investigators

  • Jerry R Colca, PhD · MSDC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2011-11-30
Completion
2011-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01103414 on ClinicalTrials.gov