Study to Evaluate the Safety and Tolerability of PBI-4050 in Type 2 Diabetes Patients With Metabolic Syndrome
Status:
Completed
Trial end date:
2016-11-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 2
Details
Lead Sponsor:
Liminal BioSciences Ltd. ProMetic BioSciences Inc.