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Main Study for Type 1 Diabetes (BF-MNN-112 Trial)

Phase 2

Recruiting

Research Sponsored by Biomea Fusion Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Males or females, age ≥18 and ≤60 years.

Treated with insulin only (no other diabetes medications) for at least 2 months prior to screening.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks

Awards & highlights

BF-MNN-112 Trial Summary

This trial is testing a new drug called BMF-219 in people with Type 1 Diabetes Mellitus.

Who is the study for?

Adults aged 18-60 with Type 1 Diabetes diagnosed within the last 3 years are eligible for this trial. They must be using only insulin to manage their diabetes, have an HbA1c level between 6.5% and 10%, a BMI of up to 40 kg/m2, and certain levels of C-peptide.Check my eligibility

What is being tested?

The trial is testing BMF-219 in people with Type 1 Diabetes to see how effective it is. Participants will receive BMF-219 under controlled conditions to monitor its impact on their blood sugar control and overall health.See study design

What are the potential side effects?

Specific side effects of BMF-219 aren't listed here, but common drug-related side effects may include nausea, low blood sugar episodes (hypoglycemia), headaches, or allergic reactions.

BF-MNN-112 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 60 years old.

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I have been using insulin exclusively for my diabetes for at least 2 months.

BF-MNN-112 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Secondary outcome measures

Incidence of adverse events

Rate of symptomatic hypoglycemic episodes

To assess hypoglycemia events

+3 more

BF-MNN-112 Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Open Label SubstudyExperimental Treatment1 Intervention

The open-label substudy will enroll participants with T1D into 2 cohorts: participants with T1D diagnosed within 3 years with C-peptide concentration ≥0.2 nmol/L (0.60 μg/L) and participants with T1D diagnosed between 3 to 15 years with C-peptide concentration ≥0.08 nmol/L (0.24 μg/L). The substudy uses a randomized, open-label design with parallel assignment between 2 treatment arms in each cohort. The substudy begins with a screening period of up to 35 days. Eligible participants will be randomly assigned by cohort to 1 of 2 treatment arms: Cohort 1: Participants with T1D diagnosed within 3 years with C-peptide concentration ≥0.2 nmol/L (0.60 μg/L) Arm A: BMF-219 100 mg QD for 12 weeks Arm B: BMF-219 200 mg QD for 12 weeks Cohort 2: Participants with T1D diagnosed between 3 to 15 years with C-peptide concentration ≥0.08 nmol/L (0.24 μg/L). Arm A: BMF-219 100 mg QD for 12 weeks Arm B: BMF-219 200 mg QD for 12 weeks

Group II: Main StudyExperimental Treatment1 Intervention

The Main Study will enroll randomized participants with T1D diagnosed within 3 years and with C-peptide concentration ≥0.2 nmol/L (0.60 μg/L). The main study uses a randomized, double-blind, placebo-controlled design with parallel assignment among 3 treatment arms . The trial begins with a screening period of up to 35 days. Eligible participants will be randomly assigned to 1 of 3 arms using a 1:1:1 ratio: Arm A: BMF-219 100 mg QD for 12 weeks Arm B: BMF-219 200 mg QD for 12 weeks Arm C: Matching placebo.

Group III: Main Study Double Blind Arm CPlacebo Group1 Intervention

Matching placebo.

0 / 2Eligibility criteria met

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Who is running the clinical trial?

Biomea Fusion Inc.Lead Sponsor

4 Previous Clinical Trials

565 Total Patients Enrolled

Juan Pablo Frias, MDStudy DirectorBiomea Fusion Inc.

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are new patients currently being enrolled in this ongoing medical study?

"Apologies for the confusion. According to the latest update on clinicaltrials.gov, this particular study is not currently seeking candidates. The trial was initially posted on December 31st, 2023 and last edited on December 21st, 2023. However, it's worth noting that there are currently 1275 other trials actively enrolling participants at this time."

Answered by AI

Has the primary research investigation received official approval from the Food and Drug Administration (FDA)?

"Based on the fact that this trial is classified as a Phase 2 study, our team at Power rates its safety level with a score of 2. While there is some supporting data regarding safety, no efficacy data has been obtained yet."

Answered by AI

Is there an age restriction for potential participants, specifically those who are above the age of 30?

"To participate in this clinical trial, patients must be within the age range of 18 to 60. It is worth noting that there are a total of 214 trials available for individuals under the age of 18 and 945 trials specifically targeting participants over the age of 65."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Phase 2 Trial of BMF-219 in Participants With Type 1 Diabetes Mellitus

2023. "Phase 2 Trial of BMF-219 in Participants With Type 1 Diabetes Mellitus". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06152042.

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