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

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ClinicalTrials.gov Identifier: NCT03081598
Recruitment Status : Active, not recruiting
First Posted : March 16, 2017
Last Update Posted : June 12, 2018
Sponsor:
Information provided by (Responsible Party):
ProMetic Pharma SMT Limited

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 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


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




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



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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03081598


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.

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    Key Record Dates
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