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

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Type 2 Diabetes Mellitus; Metabolic Syndrome	Drug: PBI-4050; Other: Placebo	Phase 2

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	268 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Treatment
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
Actual Study Start Date :	May 29, 2017
Estimated Primary Completion Date :	September 2018
Estimated Study Completion Date :	September 2018

Arms and Interventions

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Arm	Intervention/treatment
Placebo Comparator: Placebo; Daily dose of 6 capsules of placebo	Other: Placebo; Placebo soft gelatine capsule
Active Comparator: PBI-4050 400 mg; Daily dose of 2 capsules of PBI-4050 and 4 capsules of placebo	Drug: PBI-4050; Soft gelatine capsule containing 200 mg of the active ingredient per capsule; Other: Placebo; Placebo soft gelatine capsule
Active Comparator: PBI-4050 800 mg; Daily dose of 4 capsules of PBI-4050 and 2 capsules of placebo	Drug: PBI-4050; Soft gelatine capsule containing 200 mg of the active ingredient per capsule; Other: Placebo; Placebo soft gelatine capsule
Active Comparator: PBI-4050 1200 mg; Daily dose of 6 capsules of PBI-4050	Drug: PBI-4050; Soft gelatine capsule containing 200 mg of the active ingredient per capsule

Outcome Measures

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Primary Outcome Measures :

1. 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 [ Time Frame: 4 months ]
   Number of subjects with abnormal laboratory values and/or adverse events that are related to treatment
2. To evaluate the efficacy of PBI-4050 400 mg, 800 mg, and 1200 mg [ Time Frame: 3 months ]
   Change from baseline on HbA1c levels

Secondary Outcome Measures :

1. Change from baseline on diabetic biomarkers [ Time Frame: 3 months ]
   % reduction and/or increase of diabetic biomarkers such as fasting glucose, fasting insulin, fasting C-peptide
2. Change from baseline on pro-inflammatory/inflammatory biomarkers [ Time Frame: 3 months ]
   % reduction and/or increase of biomarkers such as IL-6, IL-18, adiponectin
3. To evaluate the effect of PBI-4050 on frequency of hypoglycaemia events [ Time Frame: 3 months ]
   Frequency of hypoglycaemia events

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

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Locations

Canada, Alberta
C-Health
Edmonton, Alberta, Canada
Canada, Quebec
Omnispec Clinical Research
Mirabel, Quebec, Canada
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

Sponsors and Collaborators

ProMetic Pharma SMT Limited

Investigators

Study Chair:	John Moran, MD	ProMetic Life Sciences Inc.

More Information

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Responsible Party:	ProMetic Pharma SMT Limited
ClinicalTrials.gov Identifier:	NCT03081598 History of Changes
Other Study ID Numbers:	PBI-4050-CT-9-08
First Posted:	March 16, 2017
Last Update Posted:	June 12, 2018
Last Verified:	June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

Studies a U.S. FDA-regulated Drug Product:		No
Studies a U.S. FDA-regulated Device Product:		No

Additional relevant MeSH terms:

Syndrome; Diabetes Mellitus; Diabetes Mellitus, Type 2; Metabolic Syndrome X; Disease; Pathologic Processes	Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Insulin Resistance; Hyperinsulinism