Diabetes drug trial halted: could BMF-219 have boosted insulin?
NCT ID NCT06152042
First seen Jun 27, 2026 · Last updated Aug 28, 2026 · Updated 1 time
Summary
This study tested an experimental drug called BMF-219 in people with type 1 diabetes to see if it could help their bodies produce more insulin. The trial was stopped early, but researchers planned to compare insulin levels between those who got the drug and those who got a placebo. About 37 adults with type 1 diabetes were enrolled.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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37 people
The number who actually took part.
- Started
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Dec 2023
- Finished
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Jul 2025
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Males or females, age ≥18 and ≤70 years. 2. Diagnosed with stage 3 T1D within the following timeframes: * Part 1 Cohort 1: Participants diagnosed within 3 years prior to screening. * Part 1 Cohort 2: Participants diagnosed between 3 to 15 years prior to screening * Part 2 : Participants diagnosed within 15 years prior to screening. 3. Treated with insulin only for at least 2 months prior to screening and proficient in the following in the opinion of the investigator: * Counting carbohydrates * Adjusting meal and correction boluses based on glucose readings with a stable insulin/carbohydrate ratio as well as correction factors * Adjusting insulin and dietary therapy during special situations (eg, exercise, stress, intermittent diseases) 4. HbA1c ≥6.5 and ≤10.0% at screening. 5. Fasting or stimulated C-peptide Concentration at Screening as follows: * C-peptide concentration ≥0.2 nmol/L if diagnosed within 3 years prior to screening. * C-peptide concentration ≥0.08 nmol/L if diagnosed between 3 and 15 years prior to screening. 6. Documented history of at least 1 T1D1-related autoantibody. 7. If treated with lipid-lowering therapy, the dose must be stable for at least 30 days prior to screening. 8. Men and women of childbearing potential must use adequate birth control measures for the duration of the trial and at least 90 days after discontinuing study treatment. 9. Women who are not pregnant or lactating. Exclusion Criteria: 1. Diagnosis of MODY, T2D or any other subtype of diabetes mellitus other than T1D. 2. Have had recurrence (≥2 episodes) of severe hypoglycemia 3. Known self or family history (first-degree relative) of multiple endocrine neoplasia Type 1. 4. Use of diabetes medications except insulin within 2 months prior to screening. 5. Any significant cardiovascular disease or QTcF prolongation within the last 6 months prior to screening. 6. Participants with fasting triglyceride ≥500 mg/dL. 7. Have an eGFR \<60 mL/min/1.73 m2 by the CKDEPI Creatinine Equation at screening. 8. Impaired liver function, defined as screening AST or ALT \>1.5 × ULN, Total bilirubin \>1.5 × ULN with the exception of Gilbert's Syndrome. 9. History of acute or chronic pancreatitis, complete pancreatectomy or pancreas transplants. 10. Serum lipase and/or amylase above 1.5 x ULN. 11. Known positive test for HIV, HBV surface antigen and COVID-19. 12. Diagnosis of, or treatment for, any cancer within the last 2 years with the exception of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (eg, breast carcinoma, cervical cancer in situ, melanoma in situ) treated with potentially curative therapy. 13. Active (symptomatic) celiac disease. 14. History of stomach or intestinal surgery that would potentially alter absorption and/or excretion of orally administered drugs. 15. History of cirrhosis. 16. Currently participating in a formal weight loss program and/or are currently using any drugs for weight management within 2 months of screening. 17. Use of Proton pump inhibitors (PPIs) is prohibited. 18. Treatment with a moderate or strong CYP3A4 inhibitor, inducer, or substrate within a week prior to dosing on Day 1.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Alliance for Multispecialty Research, LLC.
Norman, Oklahoma, 73069, United States
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Centricity Research
Toronto, Ontario, Canada
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Consano Clinical Research, LLC
Shavano Park, Texas, 78231, United States
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Diabetes & Glandular Disease Clinic, P.A.
San Antonio, Texas, 78229, United States
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Dr. T.G Elliott Inc. dba BC Diabetes
Vancouver, British Columbia, Canada
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Lucas Research, Inc.
Morehead City, North Carolina, 28577, United States
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Manassas Clinical Research Center
Manassas, Virginia, 20110, United States
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Oceanic Research Group
North Miami Beach, Florida, 33169, United States
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Texas Diabetes & Endocrinology
Round Rock, Texas, 78681, United States
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University Diabetes & Endocrine Consultants
Chattanooga, Tennessee, 37411, United States
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Velocity Clinical Research
Dallas, Texas, 75230, United States
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Other studies related to the condition(s) this trial covers.
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