Type 2 DiabetesPhase 1MbANCT05826054
Montbretin Clinical Trial in Healthy Volunteers and Type 2 Diabetics
A Phase 1 study testing Montbretin A in people with Type 2 Diabetes, run by Robert Petrella at 1 site in Canada.
Trial summary
The goal of this clinical trial is to test the investigational product, Montbretin A (MbA) in either individuals with type 2 diabetes (T2D) or healthy participants. The main questions it aims to answer are: Safety of MbA Whether MbA has less side effects in comparison to other medications used to treat T2D… Read more about this study
- Who is it for?
- Ages 19 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Montbretin A
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteCanada
- Study dates
- 1 Dec 2023to 25 Nov 2025
- Phase
- Phase 1
- 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 19 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female, age ≤ 65 years; ≥19 years;
- Have diagnosed type-2 diabetes mellitus with HbA1C between 6.5% to 11% that is currently managed by diet and no other medications or healthy volunteers defined as not having diagnosis of type-2 diabetes mellitus.
- Have routine and normal dietary habits that include three meals a day;
- Normal hematological parameters as determined through an in-person screening blood draw including HbA1C >4.0% in healthy volunteers.
- Use of an effective barrier method of birth control throughout the study, surgical sterility, or menopausal for at least 2 years;
- In the study team's opinion, capable of understanding the visit schedule requirement and study medication dosing requirements.
- Be able to avoid all supplements that affect blood sugar for the duration of the study eg. chromium, bitter melon, thiamine, berberine, alpha-lipoic acid, devil's claw, horse chestnut, fenugreek, ginseng, psyllium, cinnamon, garlic and panax.
Who cannot join
- Currently in poor health, as determined by the study doctor
- Currently on medication, except vitamins and/or birth control
- Not eating three regular meals a day
- Current or a history of impairment of gastro-intestinal function, including but not limited to inflammatory bowel disease, colonic ulceration, and/or partial intestinal obstruction
- Travelled to a foreign country less than four (4) weeks prior to study entry;
- Surgery less than four (4) weeks a prior to study entry;
Show all 10Show fewer
- Pregnant or lactating women;
- Planning to participate in other investigational drugs while participating in the study;
- Known allergy to study medication or its components (non-medicinal ingredients); and
- A history of noncompliance to medical regimens or inability or unwillingness to return for all scheduled visits
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 1 Dose Escalating Study for Montbretin A
The goal of this clinical trial is to test the investigational product, Montbretin A (MbA) in either individuals with type 2 diabetes (T2D) or healthy participants.
The main questions it aims to answer are:
- Safety of MbA
- Whether MbA has less side effects in comparison to other medications used to treat T2D
Participants will:
- Be given MbA at increasing amounts (10 mg to 300 mg) over a two-week treatment period, along with standardized meal;
- Undergo testing, including blood draws, blood sugar checks, electrocardiogram (ECG) and questionnaires.
Read the detailed description
BACKGROUND: Diabetes is an increasingly common disease that affects 6% of the population. It is a chronic metabolic disorder because the body cannot produce enough insulin or cannot respond well to insulin to control the amount of sugar in the blood. Insulin is a hormone secreted by the pancreas that increases the ability of tissues to absorb blood glucose. After a meal, our body will break down the nutrients in the food we eat, such as carbohydrates. These smaller nutrients are then absorbed in our small intestine into our blood. Without proper insulin function, our body is unable to lower the blood sugar and use the blood sugar correctly, leading to high blood sugar (also known as hyperglycemia). Over time, this can lead to complications in the eyes, nervous system, kidney and heart.
One type of diabetes medications, alpha-glucosidase inhibitors (AGIs), prevent blood sugar spikes (period of out of control high blood sugar levels) in diabetic patients after a meal. This type of medication prevents breakdown of carbohydrates into small sugars that can be absorbed in the gut. AGIs usually work well in preventing blood sugar spikes, but they have a number of side effects such as increased gas, bloating and diarrhea. Because of this, patients usually do not follow the recommended schedule for taking AGIs, which means the medications wont work as well.
The Study Treatment ("Montbretin A") provides another way to control blood sugar spikes after a meal. This method targets an enzyme (substance produced by body to help break down substances) found in the small intestine called human pancreatic amylase (HPA), which helps in the first step of breaking down carbohydrates. The Study Treatment works by blocking HPA from performing its function. This could potentially be used to treat T2D by preventing the initial breakdown of carbohydrates, which can lead to less sugars absorbed to the blood and better blood sugar control. MbA will lead to larger pieces of carbohydrates passed to the colon, reducing the speed of gas produced. This might lead to reduced stomach upsets.
MAIN AIM: To test the safety and tolerability (in terms of stomach-related side effects) of MbA in humans.
METHOD: This is an open-label, first-in-human, single-arm, single-center Phase I clinical trial. Participants will receive increasing dose of MbA (starting from 10 mg to 300 mg) with a standardized meal during the two-week treatment period (Weeks 1 and 2), with follow-up visits scheduled in Week 3 (one week after treatment completion) and Week 12 (nine weeks after treatment completion).
Participants are expected to participate for up to 13 weeks. This include one screening visit (one week prior to start of treatment), 2 weeks of treatment (3 visits per week for a total of 6 visits), and 2 follow-up visits (one week and nine weeks after completing treatment).
The tests that will be done in this study include:
- One blood draw at each visit
- Electrocardiogram (ECG), at screening and the first follow up visit
- Blood sugar checks, including one finger prick and continuous glucose monitoring using a device at screening and each treatment visit
- Questionnaire regarding gastrointestinal symptoms
- Gastro-Intestinal Diary (GID), which needs to be filled in daily after screening and up to one week after treatment period.
- Conditions
- Type 2 Diabetes
- Being tested
- Montbretin A
- Keywords
- Type 2 diabetes, Montbretin A, Type II Diabetes Mellitus Without Complication, Noninsulin-Dependent Diabetes Mellitus, Healthy participants
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Montbretin ADietary supplement
The investigational product is 95% pure montbretin A (MbA), a glycosylated acyl-flavonol isolated from the corms (bulbs) of the Crocosmia plant through hot water extraction. It is a potent and specific inhibitor of human pancreatic amylase (HPA).
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | In this study, participants will receive increasing dosages of the Study Treatment (Montbretin A, MbA) at each treatment visit. The Study Treatment will be taken with a standardized meal (a meal that has specified quantities of carbohydrates, fats and proteins). At each visit, participants will receive one dose (in pill form) of MbA. As long as they are not experiencing any side effects, this dose will be gradually increased at each study visit (starting from 10 mg, 25 mg, 50 mg, 100 mg, 200 mg, to 300 mg MbA). Receives: Dietary Supplement: Montbretin A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose (MTD)
The MTD is defined as the minimum dose that results in a dose limiting toxicity in the form of gastro-intestinal adverse events (relevant flatulence and/or diarrhea as determined by the Gastrointestinal Symptom Rating Scale) in 33% of the test subjects.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2023
- Study start1 Dec 2023
- Primary completion25 Nov 2025
- Study completion25 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Robert Petrella
- Sponsor type
- University, hospital or other
- Collaborators
- Michael Smith Foundation for Health Research, Canadian Glycomics Network (GlycoNet) - Networks of Centres of Excellence (NCE)
- Responsible party
- Sponsor-investigator, Robert Petrella, University of British Columbia
- Investigators
- Robert Petrella, MD, PhD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05826054
- Sponsor's protocol ID
- MbA01
- Acronym
- MbA
- Status last verified
- Aug 2026
- First submitted
- 11 Apr 2023
- Last updated
- 2 Sep 2026
- 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 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Dose Escalating Study for Montbretin A
- ClinicalTrials.gov ID
- NCT05826054
- Acronym / sponsor ID
- MbA / MbA01
- Conditions
- Type 2 Diabetes
- Keywords
- Type 2 diabetes, Montbretin A, Type II Diabetes Mellitus Without Complication, Noninsulin-Dependent Diabetes Mellitus, Healthy participants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Robert PetrellaUniversity, hospital or other
- Collaborators
- Michael Smith Foundation for Health Research, Canadian Glycomics Network (GlycoNet) - Networks of Centres of Excellence (NCE)
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 25 Nov 2025 (actual)
- Study completion
- 25 Nov 2025 (actual)
- First posted
- 24 Apr 2023 (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.
The goal of this clinical trial is to test the investigational product, Montbretin A (MbA) in either individuals with type 2 diabetes (T2D) or healthy participants.
The main questions it aims to answer are:
- Safety of MbA
- Whether MbA has less side effects in comparison to other medications used to treat T2D
Participants will:
- Be given MbA at increasing amounts (10 mg to 300 mg) over a two-week treatment period, along with standardized meal;
- Undergo testing, including blood draws, blood sugar checks, electrocardiogram (ECG) and questionnaires.
Detailed description
BACKGROUND: Diabetes is an increasingly common disease that affects 6% of the population. It is a chronic metabolic disorder because the body cannot produce enough insulin or cannot respond well to insulin to control the amount of sugar in the blood. Insulin is a hormone secreted by the pancreas that increases the ability of tissues to absorb blood glucose. After a meal, our body will break down the nutrients in the food we eat, such as carbohydrates. These smaller nutrients are then absorbed in our small intestine into our blood. Without proper insulin function, our body is unable to lower the blood sugar and use the blood sugar correctly, leading to high blood sugar (also known as hyperglycemia). Over time, this can lead to complications in the eyes, nervous system, kidney and heart.
One type of diabetes medications, alpha-glucosidase inhibitors (AGIs), prevent blood sugar spikes (period of out of control high blood sugar levels) in diabetic patients after a meal. This type of medication prevents breakdown of carbohydrates into small sugars that can be absorbed in the gut. AGIs usually work well in preventing blood sugar spikes, but they have a number of side effects such as increased gas, bloating and diarrhea. Because of this, patients usually do not follow the recommended schedule for taking AGIs, which means the medications wont work as well.
The Study Treatment ("Montbretin A") provides another way to control blood sugar spikes after a meal. This method targets an enzyme (substance produced by body to help break down substances) found in the small intestine called human pancreatic amylase (HPA), which helps in the first step of breaking down carbohydrates. The Study Treatment works by blocking HPA from performing its function. This could potentially be used to treat T2D by preventing the initial breakdown of carbohydrates, which can lead to less sugars absorbed to the blood and better blood sugar control. MbA will lead to larger pieces of carbohydrates passed to the colon, reducing the speed of gas produced. This might lead to reduced stomach upsets.
MAIN AIM: To test the safety and tolerability (in terms of stomach-related side effects) of MbA in humans.
METHOD: This is an open-label, first-in-human, single-arm, single-center Phase I clinical trial. Participants will receive increasing dose of MbA (starting from 10 mg to 300 mg) with a standardized meal during the two-week treatment period (Weeks 1 and 2), with follow-up visits scheduled in Week 3 (one week after treatment completion) and Week 12 (nine weeks after treatment completion).
Participants are expected to participate for up to 13 weeks. This include one screening visit (one week prior to start of treatment), 2 weeks of treatment (3 visits per week for a total of 6 visits), and 2 follow-up visits (one week and nine weeks after completing treatment).
The tests that will be done in this study include:
- One blood draw at each visit
- Electrocardiogram (ECG), at screening and the first follow up visit
- Blood sugar checks, including one finger prick and continuous glucose monitoring using a device at screening and each treatment visit
- Questionnaire regarding gastrointestinal symptoms
- Gastro-Intestinal Diary (GID), which needs to be filled in daily after screening and up to one week after treatment period.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Dietary Supplement: Montbretin AIn this study, participants will receive increasing dosages of the Study Treatment (Montbretin A, MbA) at each treatment visit. The Study Treatment will be taken with a standardized meal (a meal that has specified quantities of carbohydrates, fats and proteins). At each visit, participants will receive one dose (in pill form) of MbA. As long as they are not experiencing any side effects, this dose will be gradually increased at each study visit (starting from 10 mg, 25 mg, 50 mg, 100 mg, 200 mg, to 300 mg MbA). |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female, age ≤ 65 years; ≥19 years;
- Have diagnosed type-2 diabetes mellitus with HbA1C between 6.5% to 11% that is currently managed by diet and no other medications or healthy volunteers defined as not having diagnosis of type-2 diabetes mellitus.
- Have routine and normal dietary habits that include three meals a day;
- Normal hematological parameters as determined through an in-person screening blood draw including HbA1C >4.0% in healthy volunteers.
- Use of an effective barrier method of birth control throughout the study, surgical sterility, or menopausal for at least 2 years;
Key exclusion criteria (10 listed)
- Currently in poor health, as determined by the study doctor
- Currently on medication, except vitamins and/or birth control
- Not eating three regular meals a day
- Current or a history of impairment of gastro-intestinal function, including but not limited to inflammatory bowel disease, colonic ulceration, and/or partial intestinal obstruction
- Travelled to a foreign country less than four (4) weeks prior to study entry;
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 |
|---|---|---|
| Montbretin AThe investigational product is 95% pure montbretin A (MbA), a glycosylated acyl-flavonol isolated from the corms (bulbs) of the Crocosmia plant through hot water extraction. It is a potent and specific inhibitor of human pancreatic amylase (HPA). | Dietary supplement | Intervention |
Primary outcome
Maximum tolerated dose (MTD)
Time frame: 2 weeks
The MTD is defined as the minimum dose that results in a dose limiting toxicity in the form of gastro-intestinal adverse events (relevant flatulence and/or diarrhea as determined by the Gastrointestinal Symptom Rating Scale) in 33% of the test subjects.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Type 2 Diabetes
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.
Robert Petrella, MD, PhD principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Montbretin A in people with Type 2 Diabetes, run by Robert Petrella at 1 site 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 10 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: finished, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Maximum tolerated dose (MTD) (time frame: 2 weeks). 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 2 Sep 2026.