Last updated on June 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

Aline Hagerimana, MD

Omnispec Clinical Research
Mirabel, QC Canada

Aline Hagerimana, MD

LMC Clinical Research Inc.
Barrie, Canada

Aline Hagerimana, MD

C-health - C-endo Division
Calgary, Canada

Aline Hagerimana, MD

Centre de recherche clinique de Laval
Laval, Canada

Aline Hagerimana, MD

Manna Research
Quebec City, Canada

Aline Hagerimana, MD

Synergy Medical Clinic
Sherwood Park, Canada

Aline Hagerimana, MD

Manna Research
Toronto, Canada

Aline Hagerimana, MD

Manna Research
Vancouver, Canada

Aline Hagerimana, MD

Institut de Recherches Cliniques de Montreal (IRCM)
Montréal, Canada

Aline Hagerimana, MD

LMC Clinical Research Inc.
Montréal, Canada