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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
104
C-Health
Edmonton, Alberta, Canada
Omnispec Clinical Research
Mirabel, Quebec, Canada
LMC Clinical Research Inc.
Barrie, Canada
C-health - C-endo Division
Calgary, Canada
To evaluate the safety of PBI-4050 400 mg, 800 mg, and 1200 mg as assessed by the number of subjects with abnormal laboratory values and/or adverse events that are related to treatment
Number of subjects with abnormal laboratory values and/or adverse events that are related to treatment
Time frame: 4 months
To evaluate the efficacy of PBI-4050 400 mg, 800 mg, and 1200 mg
Change from baseline on HbA1c levels
Time frame: 3 months
Change from baseline on diabetic biomarkers
% reduction and/or increase of diabetic biomarkers such as fasting glucose, fasting insulin, fasting C-peptide
Time frame: 3 months
Change from baseline on pro-inflammatory/inflammatory biomarkers
% reduction and/or increase of biomarkers such as IL-6, IL-18, adiponectin
Time frame: 3 months
To evaluate the effect of PBI-4050 on frequency of hypoglycaemia events
Frequency of hypoglycaemia events
Time frame: 3 months
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Centre de recherche clinique de Laval
Laval, Canada
Institut de Recherches Cliniques de Montreal (IRCM)
Montreal, Canada
LMC Clinical Research Inc.
Montreal, Canada
Manna Research
Québec, Canada
Synergy Medical Clinic
Sherwood Park, Canada
Manna Research
Toronto, Canada
...and 1 more locations