Study to Evaluate Safety, Efficacy of PBI-4050 & Its Effect on Relevant Biomarkers in T2DM Patients With Metabolic Syndrome
NCT ID: NCT03081598
Last Updated: 2020-12-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
104 participants
INTERVENTIONAL
2017-05-29
2018-09-06
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Daily dose of 6 capsules of placebo
Placebo
Placebo soft gelatine capsule
PBI-4050 400 mg
Daily dose of 2 capsules of PBI-4050 and 4 capsules of placebo
PBI-4050
Soft gelatine capsule containing 200 mg of the active ingredient per capsule
Placebo
Placebo soft gelatine capsule
PBI-4050 800 mg
Daily dose of 4 capsules of PBI-4050 and 2 capsules of placebo
PBI-4050
Soft gelatine capsule containing 200 mg of the active ingredient per capsule
Placebo
Placebo soft gelatine capsule
PBI-4050 1200 mg
Daily dose of 6 capsules of PBI-4050
PBI-4050
Soft gelatine capsule containing 200 mg of the active ingredient per capsule
Interventions
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PBI-4050
Soft gelatine capsule containing 200 mg of the active ingredient per capsule
Placebo
Placebo soft gelatine capsule
Eligibility Criteria
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Inclusion Criteria
2. Subject has signed written informed consent.
3. Subject has a clinical diagnosis of T2DM with an HbA1c level between ≥ 7.5% and ≤ 10%.
4. Subject has been receiving stable antidiabetic therapy (with or without basal insulin) for a minimum of 3 months before the screening visit.
5. Subject is able and willing to self-monitor blood glucose level at home.
6. Subject has a body mass index (BMI) of ≥ 27 kg/m2 and ≤ 45 kg/m2.
7. Subject has metabolic syndrome, having at least 3 of the 5 risk factors.
Exclusion Criteria
2. Subject is taking basal insulin dose \> 1.0 U/kg/day.
3. Subject has recent or on-going infection requiring systemic treatment with an anti-infective agent within 30 days before screening.
4. Subject has a history of pancreatitis or diabetic ketoacidosis.
5. Subject has had at least one episode of severe hypoglycaemia in the past 12 months.
6. Subject has evidence of significant cardiovascular disease within 3 months before screening.
7. Subject has an estimated glomerular filtration rate (eGFR) \< 60 mL/min/1.73 m2.
8. Subject has uncontrolled hypertension.
9. Subject has a diagnosis of rheumatic or inflammatory disease; or other autoimmune or inflammatory disease.
10. Subject is concurrently taking and plans to routinely continue taking anti-inflammatory medications during the study.
11. Subject is currently using medications for the indication of (or at the doses indicated for) weight loss.
12. Subject has significantly elevated liver enzyme levels.
13. History of malignancy of any organ system, treated or untreated, within the past 5 years other than basal or squamous cell skin cancer.
14. Subject has a history of chronic alcohol or other substance abuse.
15. Subject has a history of an allergic reaction to PBI-4050 or any of its excipients.
18 Years
ALL
No
Sponsors
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Liminal BioSciences Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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John Moran, MD
Role: STUDY_CHAIR
ProMetic Life Sciences Inc.
Locations
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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)
Montreal, , Canada
LMC Clinical Research Inc.
Montreal, , Canada
Manna Research
Québec, , Canada
Synergy Medical Clinic
Sherwood Park, , Canada
Manna Research
Toronto, , Canada
Manna Research
Vancouver, , Canada
Countries
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Other Identifiers
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PBI-4050-CT-9-08
Identifier Type: -
Identifier Source: org_study_id