NCT03081598

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

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 104 (actual)
• Sponsor: Liminal BioSciences Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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 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.

Conditions

• Type 2 Diabetes Mellitus
• Metabolic Syndrome

Interventions

Type	Name	Description
DRUG	PBI-4050	Soft gelatine capsule containing 200 mg of the active ingredient per capsule
OTHER	Placebo	Placebo soft gelatine capsule

Timeline

• Start date: 2017-05-29
• Primary completion: 2018-09-06
• Completion: 2018-09-06
• First posted: 2017-03-16
• Last updated: 2020-12-08

Locations

11 sites across 1 country: Canada