Type 2 Diabetes MellitusPhase 2NCT03081598
Study to Evaluate Safety, Efficacy of PBI-4050 & Its Effect on Relevant Biomarkers in T2DM Patients With Metabolic Syndrome
A Phase 2 study testing PBI-4050 in people with Type 2 Diabetes Mellitus and Metabolic Syndrome, run by Liminal BioSciences Ltd. at 11 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus, Metabolic Syndrome
- What is being tested?
- PBI-4050
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 104 participants
- Where
- 11 sitesCanada
- Study dates
- 29 May 2017to 6 Sep 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 15Show fewer
- 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.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Canada11 sites
LMC Clinical Research Inc.
Barrie
C-health - C-endo Division
Calgary
C-Health
Edmonton, Alberta
Centre de recherche clinique de Laval
Laval
Omnispec Clinical Research
Mirabel, Quebec
Institut de Recherches Cliniques de Montreal (IRCM)
Montreal
LMC Clinical Research Inc.
Montreal
Manna Research
Québec
Synergy Medical Clinic
Sherwood Park
Manna Research
Toronto
Manna Research
Vancouver
About this study
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
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.
Read the 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.
- Conditions
- Type 2 Diabetes Mellitus, Metabolic Syndrome
- Being tested
- PBI-4050, Placebo
- Medical subject headings
- Diabetes Mellitus, Type 2, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PBI-4050Drug
Soft gelatine capsule containing 200 mg of the active ingredient per capsule
PlaceboOther
Placebo soft gelatine capsule
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Daily dose of 6 capsules of placebo Receives: Other: Placebo |
| PBI-4050 400 mg | Active comparator | Daily dose of 2 capsules of PBI-4050 and 4 capsules of placebo Receives: Drug: PBI-4050; Other: Placebo |
| PBI-4050 800 mg | Active comparator | Daily dose of 4 capsules of PBI-4050 and 2 capsules of placebo Receives: Drug: PBI-4050; Other: Placebo |
| PBI-4050 1200 mg | Active comparator | Daily dose of 6 capsules of PBI-4050 Receives: Drug: PBI-4050 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 4 months
To evaluate the efficacy of PBI-4050 400 mg, 800 mg, and 1200 mg
Change from baseline on HbA1c levels
Measured: 3 months
Secondary outcomes (3)
Change from baseline on diabetic biomarkers
% reduction and/or increase of diabetic biomarkers such as fasting glucose, fasting insulin, fasting C-peptide
Measured: 3 months
Change from baseline on pro-inflammatory/inflammatory biomarkers
% reduction and/or increase of biomarkers such as IL-6, IL-18, adiponectin
Measured: 3 months
To evaluate the effect of PBI-4050 on frequency of hypoglycaemia events
Frequency of hypoglycaemia events
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2017
- Study start29 May 2017
- Primary completion6 Sep 2018
- Study completion6 Sep 2018
Why it stopped: Failure to meet recruitment target during the recruitment period
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Liminal BioSciences Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John Moran, MD, Study chair, ProMetic Life Sciences Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03081598
- Sponsor's protocol ID
- PBI-4050-CT-9-08
- Status last verified
- Dec 2020
- First submitted
- 10 Mar 2017
- Last updated
- 8 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03081598
- Acronym / sponsor ID
- PBI-4050-CT-9-08
- Conditions
- Type 2 Diabetes Mellitus, Metabolic Syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Failure to meet recruitment target during the recruitment period
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Liminal BioSciences Ltd.Industry (pharma, biotech, devices)
- Study start
- 29 May 2017 (actual)
- Primary completion
- 6 Sep 2018 (actual)
- Study completion
- 6 Sep 2018 (actual)
- First posted
- 16 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: PlaceboDaily dose of 6 capsules of placebo |
| PBI-4050 400 mg | Active comparator | Drug: PBI-4050, Other: PlaceboDaily dose of 2 capsules of PBI-4050 and 4 capsules of placebo |
| PBI-4050 800 mg | Active comparator | Drug: PBI-4050, Other: PlaceboDaily dose of 4 capsules of PBI-4050 and 2 capsules of placebo |
| PBI-4050 1200 mg | Active comparator | Drug: PBI-4050Daily dose of 6 capsules of PBI-4050 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PBI-4050Soft gelatine capsule containing 200 mg of the active ingredient per capsule | Drug | PBI-4050 1200 mg, PBI-4050 400 mg, PBI-4050 800 mg |
| PlaceboPlacebo soft gelatine capsule | Other | PBI-4050 400 mg, PBI-4050 800 mg, Placebo |
Primary outcome
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
3 secondary outcomes
Change from baseline on diabetic biomarkers
Time frame: 3 months
Change from baseline on pro-inflammatory/inflammatory biomarkers
Time frame: 3 months
To evaluate the effect of PBI-4050 on frequency of hypoglycaemia events
Time frame: 3 months
Results and safety
The study was stopped early (reason given: Failure to meet recruitment target during the recruitment period). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2020.
- Individual participant dataSharing planned: No
Related trials for Type 2 Diabetes Mellitus
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Moran, MD study chair
ProMetic Life Sciences Inc.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PBI-4050 in people with Type 2 Diabetes Mellitus and Metabolic Syndrome, run by Liminal BioSciences Ltd. at 11 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Failure to meet recruitment target during the recruitment period). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2020.