Clinical trial NCT03081598: Study to Evaluate Safety, Efficacy of PBI-4050 & Its Effect on Relevant Biomarkers in T2DM Patients With Metabolic Syndrome
Official title: A Phase 2, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety and Efficacy of PBI-4050 in Type 2 Diabetes Mellitus Patients With Metabolic Syndrome
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Type 2 Diabetes Mellitus
Metabolic Syndrome
Lead sponsor: Liminal BioSciences Ltd.
Sponsor class: INDUSTRY
First posted: 2017-03-16
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: This Phase 2 study will be performed by 15 sites in Canada. The total duration of study participation for each subject is approximately 20 weeks and comprises 6 study visits

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.

Eligibility criteria: Inclusion Criteria:

1. Subject is 18 years of age or older.
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:

1. Subject is using prandial insulin or pre-mixed insulin in addition to oral hypoglycaemic agents for blood glucose control.
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.

Primary outcomes:
measure: 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
timeFrame: 4 months
measure: To evaluate the efficacy of PBI-4050 400 mg, 800 mg, and 1200 mg
timeFrame: 3 months
Secondary outcomes:
measure: Change from baseline on diabetic biomarkers
timeFrame: 3 months
measure: Change from baseline on pro-inflammatory/inflammatory biomarkers
timeFrame: 3 months
measure: To evaluate the effect of PBI-4050 on frequency of hypoglycaemia events
timeFrame: 3 months
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: C-Health
state: Alberta
city: Mirabel
country: Canada
facility: Omnispec Clinical Research
state: Quebec
city: Barrie
country: Canada
facility: LMC Clinical Research Inc.
city: Calgary
country: Canada
facility: C-health - C-endo Division
city: Laval
country: Canada
facility: Centre de recherche clinique de Laval
city: Montréal
country: Canada
facility: Institut de Recherches Cliniques de Montreal (IRCM)
city: Montréal
country: Canada
facility: LMC Clinical Research Inc.
city: Quebec City
country: Canada
facility: Manna Research
city: Sherwood Park
country: Canada
facility: Synergy Medical Clinic
city: Toronto
country: Canada
facility: Manna Research
city: Vancouver
country: Canada
facility: Manna Research
Study officials:
affiliation: ProMetic Life Sciences Inc.
name: John Moran, MD
role: STUDY_CHAIR
References: