Type 2 Diabetes Mellitus Clinical Trial
Official title:
A Phase 2, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety and Efficacy of PBI-4050 in Type 2 Diabetes Mellitus Patients With Metabolic Syndrome
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. ;
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