Last updated on March 2018

Study to Evaluate Safety Efficacy of PBI-4050 & Its Effect on Relevant Biomarkers in T2DM Patients With Metabolic Syndrome


Brief description of study

This is a Phase 2, multi-center, double-blind, placebo-controlled study of the safety and effect of PBI-4050 at doses ranging from 400 mg to 1200 mg on relevant biomarkers in subjects with inadequately-controlled T2DMS on stable background antidiabetic therapy.

Detailed Study Description

This Phase 2 study will be performed by 15 sites in Canada. The total duration of study participation for each subject is approximately 20 weeks and comprises 6 study visits

A total of approximately 268 subjects will be enrolled in the study and randomly assigned to one of the following 4 treatment groups:

  • PBI-4050 400 mg
  • PBI-4050 800 mg
  • PBI-4050 1200 mg
  • Placebo

All subjects will receive the assigned study drug for 12 weeks.

Clinical Study Identifier: NCT03081598

Contact Investigators or Research Sites near you

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Aline Hagerimana, MD

C-Health
Edmonton, AB Canada
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Aline Hagerimana, MD

Omnispec Clinical Research
Mirabel, QC Canada
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Aline Hagerimana, MD

LMC Clinical Research Inc.
Barrie, Canada
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Aline Hagerimana, MD

C-health - C-endo Division
Calgary, Canada
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Aline Hagerimana, MD

Centre de recherche clinique de Laval
Laval, Canada
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Aline Hagerimana, MD

Manna Research
Quebec City, Canada
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Aline Hagerimana, MD

Synergy Medical Clinic
Sherwood Park, Canada
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Aline Hagerimana, MD

Manna Research
Toronto, Canada
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Aline Hagerimana, MD

Manna Research
Vancouver, Canada
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Aline Hagerimana, MD

Institut de Recherches Cliniques de Montreal (IRCM)
Montréal, Canada
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Aline Hagerimana, MD

LMC Clinical Research Inc.
Montréal, Canada
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