NCT02562573

Study to Evaluate the Safety and Tolerability of PBI-4050 in Type 2 Diabetes Patients With Metabolic Syndrome

A Phase 2, Single-Arm, Open-Label Study to Evaluate the Safety and Tolerability of PBI-4050 in Type 2 Diabetes Patients With Metabolic Syndrome

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Liminal BioSciences Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 2, open-label, single-arm study of the safety and tolerability of PBI-4050 800 mg daily oral administration in type 2 diabetes patients with metabolic syndrome. A total of 12 patients will initially be enrolled for study participation. A Data Safety Monitoring Board (DSMB) will continuously review data obtained from the 12 patients. When the 12 patients have completed at least one month of study treatment, the DSMB will meet and determine whether additional patients may be enrolled or the study should be stopped. If the safety is deemed acceptable to continue with the study, the study will enroll a maximum of 36 patients.

Detailed description

This Phase 2 study will be performed by 1 site in Canada. The total duration of study participation for each patient is at least 18 weeks and comprises 6 study visits. Patients who choose to participate in the extension study will be in the study for a total of up to 32 weeks.

Conditions

• Type 2 Diabetes
• Metabolic Syndrome

Interventions

Type	Name	Description
DRUG	PBI4050

Timeline

• Start date: 2015-05-01
• Primary completion: 2016-11-01
• Completion: 2016-11-01
• First posted: 2015-09-29
• Last updated: 2017-04-11

Locations

1 site across 1 country: Canada