Study to Evaluate Safety, Efficacy of PBI-4050 & Its Effect on Relevant Biomarkers in T2DM Patients With Metabolic Syndrome
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03081598 |
Recruitment Status :
Terminated
(Failure to meet recruitment target during the recruitment period)
First Posted : March 16, 2017
Last Update Posted : December 8, 2020
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Type 2 Diabetes Mellitus Metabolic Syndrome | Drug: PBI-4050 Other: Placebo | Phase 2 |
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) |
Actual Enrollment : | 104 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 |
Actual Primary Completion Date : | September 6, 2018 |
Actual Study Completion Date : | September 6, 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 |
- 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
- To evaluate the efficacy of PBI-4050 400 mg, 800 mg, and 1200 mg [ Time Frame: 3 months ]Change from baseline on HbA1c levels
- 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
- 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
- To evaluate the effect of PBI-4050 on frequency of hypoglycaemia events [ Time Frame: 3 months ]Frequency of hypoglycaemia events

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

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
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 |
Study Chair: | John Moran, MD | ProMetic Life Sciences Inc. |
Responsible Party: | Liminal BioSciences Ltd. |
ClinicalTrials.gov Identifier: | NCT03081598 |
Other Study ID Numbers: |
PBI-4050-CT-9-08 |
First Posted: | March 16, 2017 Key Record Dates |
Last Update Posted: | December 8, 2020 |
Last Verified: | December 2020 |
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 |
Diabetes Mellitus Diabetes Mellitus, Type 2 Metabolic Syndrome Syndrome Disease Pathologic Processes |
Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Insulin Resistance Hyperinsulinism |