search
Back to results

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

Primary Purpose

Type 2 Diabetes Mellitus, Metabolic Syndrome

Status
Terminated
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
PBI-4050
Placebo
Sponsored by
Liminal BioSciences Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • C-Health
  • Omnispec Clinical Research
  • LMC Clinical Research Inc.
  • C-health - C-endo Division
  • Centre de recherche clinique de Laval
  • Institut de Recherches Cliniques de Montreal (IRCM)
  • LMC Clinical Research Inc.
  • Manna Research
  • Synergy Medical Clinic
  • Manna Research
  • Manna Research

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Placebo

PBI-4050 400 mg

PBI-4050 800 mg

PBI-4050 1200 mg

Arm Description

Daily dose of 6 capsules of placebo

Daily dose of 2 capsules of PBI-4050 and 4 capsules of placebo

Daily dose of 4 capsules of PBI-4050 and 2 capsules of placebo

Daily dose of 6 capsules of PBI-4050

Outcomes

Primary Outcome Measures

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
To evaluate the efficacy of PBI-4050 400 mg, 800 mg, and 1200 mg
Change from baseline on HbA1c levels

Secondary Outcome Measures

Change from baseline on diabetic biomarkers
% reduction and/or increase of diabetic biomarkers such as fasting glucose, fasting insulin, fasting C-peptide
Change from baseline on pro-inflammatory/inflammatory biomarkers
% reduction and/or increase of biomarkers such as IL-6, IL-18, adiponectin
To evaluate the effect of PBI-4050 on frequency of hypoglycaemia events
Frequency of hypoglycaemia events

Full Information

First Posted
March 10, 2017
Last Updated
December 7, 2020
Sponsor
Liminal BioSciences Ltd.
search

1. Study Identification

Unique Protocol Identification Number
NCT03081598
Brief Title
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

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Terminated
Why Stopped
Failure to meet recruitment target during the recruitment period
Study Start Date
May 29, 2017 (Actual)
Primary Completion Date
September 6, 2018 (Actual)
Study Completion Date
September 6, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Liminal BioSciences Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus, Metabolic Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
104 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Daily dose of 6 capsules of placebo
Arm Title
PBI-4050 400 mg
Arm Type
Active Comparator
Arm Description
Daily dose of 2 capsules of PBI-4050 and 4 capsules of placebo
Arm Title
PBI-4050 800 mg
Arm Type
Active Comparator
Arm Description
Daily dose of 4 capsules of PBI-4050 and 2 capsules of placebo
Arm Title
PBI-4050 1200 mg
Arm Type
Active Comparator
Arm Description
Daily dose of 6 capsules of PBI-4050
Intervention Type
Drug
Intervention Name(s)
PBI-4050
Intervention Description
Soft gelatine capsule containing 200 mg of the active ingredient per capsule
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo soft gelatine capsule
Primary Outcome Measure Information:
Title
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
Description
Number of subjects with abnormal laboratory values and/or adverse events that are related to treatment
Time Frame
4 months
Title
To evaluate the efficacy of PBI-4050 400 mg, 800 mg, and 1200 mg
Description
Change from baseline on HbA1c levels
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Change from baseline on diabetic biomarkers
Description
% reduction and/or increase of diabetic biomarkers such as fasting glucose, fasting insulin, fasting C-peptide
Time Frame
3 months
Title
Change from baseline on pro-inflammatory/inflammatory biomarkers
Description
% reduction and/or increase of biomarkers such as IL-6, IL-18, adiponectin
Time Frame
3 months
Title
To evaluate the effect of PBI-4050 on frequency of hypoglycaemia events
Description
Frequency of hypoglycaemia events
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject is 18 years of age or older. Subject has signed written informed consent. Subject has a clinical diagnosis of T2DM with an HbA1c level between ≥ 7.5% and ≤ 10%. Subject has been receiving stable antidiabetic therapy (with or without basal insulin) for a minimum of 3 months before the screening visit. Subject is able and willing to self-monitor blood glucose level at home. Subject has a body mass index (BMI) of ≥ 27 kg/m2 and ≤ 45 kg/m2. Subject has metabolic syndrome, having at least 3 of the 5 risk factors. Exclusion Criteria: Subject is using prandial insulin or pre-mixed insulin in addition to oral hypoglycaemic agents for blood glucose control. Subject is taking basal insulin dose > 1.0 U/kg/day. Subject has recent or on-going infection requiring systemic treatment with an anti-infective agent within 30 days before screening. Subject has a history of pancreatitis or diabetic ketoacidosis. Subject has had at least one episode of severe hypoglycaemia in the past 12 months. Subject has evidence of significant cardiovascular disease within 3 months before screening. Subject has an estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m2. Subject has uncontrolled hypertension. Subject has a diagnosis of rheumatic or inflammatory disease; or other autoimmune or inflammatory disease. Subject is concurrently taking and plans to routinely continue taking anti-inflammatory medications during the study. Subject is currently using medications for the indication of (or at the doses indicated for) weight loss. Subject has significantly elevated liver enzyme levels. History of malignancy of any organ system, treated or untreated, within the past 5 years other than basal or squamous cell skin cancer. Subject has a history of chronic alcohol or other substance abuse. Subject has a history of an allergic reaction to PBI-4050 or any of its excipients.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Moran, MD
Organizational Affiliation
ProMetic Life Sciences Inc.
Official's Role
Study Chair
Facility Information:
Facility Name
C-Health
City
Edmonton
State/Province
Alberta
Country
Canada
Facility Name
Omnispec Clinical Research
City
Mirabel
State/Province
Quebec
Country
Canada
Facility Name
LMC Clinical Research Inc.
City
Barrie
Country
Canada
Facility Name
C-health - C-endo Division
City
Calgary
Country
Canada
Facility Name
Centre de recherche clinique de Laval
City
Laval
Country
Canada
Facility Name
Institut de Recherches Cliniques de Montreal (IRCM)
City
Montréal
Country
Canada
Facility Name
LMC Clinical Research Inc.
City
Montréal
Country
Canada
Facility Name
Manna Research
City
Quebec City
Country
Canada
Facility Name
Synergy Medical Clinic
City
Sherwood Park
Country
Canada
Facility Name
Manna Research
City
Toronto
Country
Canada
Facility Name
Manna Research
City
Vancouver
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs