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

NCT03081598 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 104

Last updated 2020-12-08

No results posted yet for this study

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.

Conditions

Interventions

DRUG

PBI-4050

Soft gelatine capsule containing 200 mg of the active ingredient per capsule

OTHER

Placebo

Placebo soft gelatine capsule

Sponsors & Collaborators

  • Liminal BioSciences Ltd.

    lead INDUSTRY

Principal Investigators

  • John Moran, MD · ProMetic Life Sciences Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-29
Primary Completion
2018-09-06
Completion
2018-09-06

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03081598 on ClinicalTrials.gov