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New treatment option for Type 2 Diabetes
Official title Montbretin Clinical Trial in Healthy Volunteers and Type 2 Diabetics
ClinicalTrials.gov ID: NCT05826054
What this study is testing
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- Time commitment: about 13 weeks
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 19 to 65. Healthy volunteers may be eligible.
You may be able to join if
- 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...
- 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;
You likely can't join if
- 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...
- 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;
See the full eligibility criteria
- 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...
- 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;
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Vancouver, British Columbia, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 13 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 19 years to 65 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Vancouver, British Columbia, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.