Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Diabetes drug trial halted: could BMF-219 have boosted insulin?

NCT ID NCT06152042

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

37 people

The number who actually took part.

Started

Dec 2023

Finished

Jul 2025

Lead sponsor

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

18 to 70 years

Sex

Anyone

Healthy volunteers

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

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.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Type 1 diabetes mellitus are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

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

  • Alliance for Multispecialty Research, LLC.

    Norman, Oklahoma, 73069, United States

  • Centricity Research

    Toronto, Ontario, Canada

  • Consano Clinical Research, LLC

    Shavano Park, Texas, 78231, United States

  • Diabetes & Glandular Disease Clinic, P.A.

    San Antonio, Texas, 78229, United States

  • Dr. T.G Elliott Inc. dba BC Diabetes

    Vancouver, British Columbia, Canada

  • Lucas Research, Inc.

    Morehead City, North Carolina, 28577, United States

  • Manassas Clinical Research Center

    Manassas, Virginia, 20110, United States

  • Oceanic Research Group

    North Miami Beach, Florida, 33169, United States

  • Texas Diabetes & Endocrinology

    Round Rock, Texas, 78681, United States

  • University Diabetes & Endocrine Consultants

    Chattanooga, Tennessee, 37411, United States

  • Velocity Clinical Research

    Dallas, Texas, 75230, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.