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BMF-219 for Type 2 Diabetes
Study Summary
This trial tests safety, tolerability & effects of BMF-219, an oral drug for adults with Type 2 Diabetes Mellitus.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Media Library
- If you are taking metformin, you must have been taking at least 500mg per day consistently before the screening visit.You smoke more than 5 cigarettes a day and you are a healthy individual.If you're a healthy individual, you're taking medication that can't be stopped during the screening process.If you are a healthy person, you cannot be taking proton pump inhibitors.If you drink too many beverages containing methylxanthine, you cannot participate.You have a known or suspected allergy to the trial product or its ingredients.If you are a healthy person, you cannot have a history of severe allergies to multiple drugs.If you are a healthy person, you are not currently dieting or taking any weight management medications.You have type 2 diabetes and a personal or family history of multiple endocrine neoplasia type 1.If you have Type 2 Diabetes, you will be excluded from the study if you have a history of acute or chronic pancreatitis.You have type 2 diabetes, but you cannot participate if you have current infections of HIV, HCV, HBV, or COVID-19.If you have type 2 diabetes, you cannot be currently dieting or taking medication for weight loss.If you have type 2 diabetes, you cannot take proton pump inhibitors.You have type 2 diabetes and are allergic to the trial product, similar compounds, or ingredients.Your blood sugar level (measured by HbA1c) must be between 7.0% and 10%.If you have type 2 diabetes, you cannot have untreated or uncontrolled thyroid problems.You have type 2 diabetes and have severe nerve damage.If you have type 2 diabetes, you cannot have been diagnosed with or treated for any cancer in the past 2 years.If you have Type 2 Diabetes, you are excluded if you have a history of cirrhosis.You have type 2 diabetes and smoke more than 3 cigarettes per day.You are in good health based on your medical history, physical exam, ECG, and lab results.Your body mass index (BMI) falls between 18 and 35, which is considered a healthy weight range.You are between 18 and 65 years old, regardless of your gender.Female participants must not be pregnant or breastfeeding. If they can still have children, they must have a negative pregnancy test and use birth control during the study and for about 90 days after the study ends. They must also agree not to donate eggs or undergo fertility treatments during the study.You need to be able to understand and sign a paper that explains the study procedures and agree to follow them.If you are a man with a female partner who could become pregnant, you must agree to use at least two effective methods of birth control during the study and for 90 days after the study ends. You should also avoid donating sperm during this time. If you want to have children in the future, you should talk to your doctor about sperm donation and freezing before starting the treatment.You have been diagnosed with type 2 diabetes within the past 15 years.You manage your diabetes with diet and exercise or take up to three specific medications. You have been taking the same dose of these medications for at least two months before the screening.If you are a healthy person, you cannot participate in the study if you or a family member has a condition called multiple endocrine neoplasia Type 1.You have Type 2 Diabetes Mellitus or any other forms of diabetes, but not Type 1 Diabetes Mellitus. You should not have a history of diabetic ketoacidosis.You have type 2 diabetes and cannot have used any drugs except marijuana, or eaten any poppy seed-containing products 48 hours before the study.If you have type 2 diabetes, you cannot have taken corticosteroids by mouth or injection in the past 60 days before starting the study.If you have Type 2 Diabetes, you will be excluded if you have a history of severe drug allergies or multiple allergies.
- Group 1: Phase 1 (SAD Cohorts)
- Group 2: Phase 1 single dose, 3-period crossover, food effect substudy in 2 cohorts.
- Group 3: Phase 2 (MAD Cohorts)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Is this study allowing participants who are of legal age?
"This medical study is accepting patients aged between 18 and 65 years."
Are investigators in this trial actively seeking participants?
"Data from clinicaltrials.gov indicates that this trial has been actively recruiting since August 17th 2022 and was last updated on February 22nd 2023."
How many individuals are involved in this research endeavor?
"In order for this medical trial to move forward, 188 volunteers who qualify under the stated inclusion criteria have to be recruited. Potential participants can join from either Sunbright Health Research Centers in Homestead, Florida or Clinical Trials of Texas, LLC in San Antonio, Texas."
To what demographic is this research endeavor open?
"This medical trial seeks to recruit 188 individuals aged 18-65, who have been diagnosed with type 2 diabetes within the past 15 years and are currently managed by lifestyle management or no more than 3 anti-diabetic medications. Participants must also meet a range of criteria such as BMI between 18-35 kg/m2, healthy based on their medical history, physical examination ECG and laboratory data. For females this includes not being pregnant or lactating postmenopausal for at least one year without taking oral contraceptives (OCPs) without an alternative cause and using adequate contraception during the study period plus 90 days afterwards while males must commit to either abst"
What is the desired result of this rigorous investigation?
"The fundamental purpose of this 14-month clinical trial is to assess the effects of fed conditions on pharmacokinetic (PK) and treatment emergent adverse events(TEAEs) following single and multiple doses of BMF-219 in healthy individuals. Secondary goals include examining the impact of BMF-219 on glucose levels in participants with type 2 diabetes mellitus, beta cell function within these patients, as well as lipid parameters. To do so, continuous glucose monitoring profiles will be generated alongside descriptive summaries for proinsulin/insulin ratios and free fatty acid concentrations."
Who else is applying?
What state do they live in?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
What questions have other patients asked about this trial?
Why did patients apply to this trial?
How responsive is this trial?
Typically responds via
Most responsive sites:
- Catalina Research Institute: < 24 hours
- San Bernardino: < 48 hours
Average response time
- < 2 Days
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