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

NCT03081598 | Terminated Phase 2

• 1 other identifier: PBI-4050-CT-9-08
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 11

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.

Conditions

Type 2 Diabetes Mellitus; Metabolic Syndrome

Outcome Measures

Primary Outcomes (2)

• 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

  4 months

• To evaluate the efficacy of PBI-4050 400 mg, 800 mg, and 1200 mg

  Change from baseline on HbA1c levels

  3 months

Secondary Outcomes (3)

• Change from baseline on diabetic biomarkers

  3 months

• Change from baseline on pro-inflammatory/inflammatory biomarkers

  3 months

• To evaluate the effect of PBI-4050 on frequency of hypoglycaemia events

  3 months

Study Arms (4)

Placebo

PLACEBO COMPARATOR

Daily dose of 6 capsules of placebo

Other: Placebo

PBI-4050 400 mg

ACTIVE COMPARATOR

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

Drug: PBI-4050; Other: Placebo

PBI-4050 800 mg

ACTIVE COMPARATOR

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

Drug: PBI-4050; Other: Placebo

PBI-4050 1200 mg

ACTIVE COMPARATOR

Daily dose of 6 capsules of PBI-4050

Drug: PBI-4050

Interventions

PBI-4050 DRUG

Soft gelatine capsule containing 200 mg of the active ingredient per capsule

PBI-4050 1200 mg; PBI-4050 400 mg; PBI-4050 800 mg

Placebo OTHER

Placebo soft gelatine capsule

PBI-4050 400 mg; PBI-4050 800 mg; Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Liminal BioSciences Ltd.: lead

Study Sites (11)

C-Health

Edmonton, Alberta, Canada

Location

Omnispec Clinical Research

Mirabel, Quebec, Canada

Location

LMC Clinical Research Inc.

Barrie, Canada

Location

C-health - C-endo Division

Calgary, Canada

Location

Centre de recherche clinique de Laval

Laval, Canada

Location

Institut de Recherches Cliniques de Montreal (IRCM)

Montreal, Canada

Location

LMC Clinical Research Inc.

Montreal, Canada

Location

Manna Research

Québec, Canada

Location

Synergy Medical Clinic

Sherwood Park, Canada

Location

Manna Research

Toronto, Canada

Location

Manna Research

Vancouver, Canada

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Metabolic Syndrome

Interventions

setogepram

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Insulin Resistance; Hyperinsulinism

Study Officials

• John Moran, MD

  ProMetic Life Sciences Inc.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2017
• First Posted: March 16, 2017
• Study Start: May 29, 2017
• Primary Completion: September 6, 2018
• Study Completion: September 6, 2018
• Last Updated: December 8, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (11)