| Trial ID: | L7093 |
| Source ID: | NCT03081598
|
| Associated Drug: |
Pbi-4050
|
| Title: |
Study to Evaluate Safety, Efficacy of PBI-4050 & Its Effect on Relevant Biomarkers in T2DM Patients With Metabolic Syndrome
|
| Acronym: |
|
| Status: |
TERMINATED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes Mellitus|Metabolic Syndrome
|
| Interventions: |
DRUG: PBI-4050|OTHER: Placebo
|
| Outcome Measures: |
Primary: To evaluate the safety of PBI-4050 400 mg, 800 mg, and 1200 mg as assessed by the number of subjects with abnormal laboratory values and/or adverse events that are related to treatment, Number of subjects with abnormal laboratory values and/or adverse events that are related to treatment, 4 months|To evaluate the efficacy of PBI-4050 400 mg, 800 mg, and 1200 mg, Change from baseline on HbA1c levels, 3 months | Secondary: Change from baseline on diabetic biomarkers, % reduction and/or increase of diabetic biomarkers such as fasting glucose, fasting insulin, fasting C-peptide, 3 months|Change from baseline on pro-inflammatory/inflammatory biomarkers, % reduction and/or increase of biomarkers such as IL-6, IL-18, adiponectin, 3 months|To evaluate the effect of PBI-4050 on frequency of hypoglycaemia events, Frequency of hypoglycaemia events, 3 months
|
| Sponsor/Collaborators: |
Sponsor: Liminal BioSciences Ltd.
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
104
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2017-05-29
|
| Completion Date: |
2018-09-06
|
| Results First Posted: |
|
| Last Update Posted: |
2020-12-08
|
| Locations: |
C-Health, Edmonton, Alberta, Canada|Omnispec Clinical Research, Mirabel, Quebec, Canada|LMC Clinical Research Inc., Barrie, Canada|C-health - C-endo Division, Calgary, Canada|Centre de recherche clinique de Laval, Laval, Canada|Institut de Recherches Cliniques de Montreal (IRCM), Montréal, Canada|LMC Clinical Research Inc., Montréal, Canada|Manna Research, Quebec City, Canada|Synergy Medical Clinic, Sherwood Park, Canada|Manna Research, Toronto, Canada|Manna Research, Vancouver, Canada
|
| URL: |
https://clinicaltrials.gov/show/NCT03081598
|
