What is the mechanism of action of this treatment?

Common treatments for Type 1 Diabetes (T1D) primarily include insulin therapy, which replaces the insulin that the body can no longer produce, and helps regulate blood glucose levels. Emerging treatments, such as the use of butyrate (as in BKR-017), focus on improving metabolic control through anti-inflammatory properties and modulation of gut microbiota. Butyrate increases the production of glucose-regulating hormones like GLP-1 and PYY, which enhance insulin secretion and sensitivity. This is significant for T1D patients as it offers a potential adjunctive therapy to improve glycemic control and reduce inflammation, potentially leading to better overall management of the disease.

What side effects are associated with this type of intervention?

Common treatments for Type 1 Diabetes include insulin therapy, which can cause hypoglycemia, weight gain, and injection site reactions. Butyrate, a short-chain fatty acid being studied for its potential benefits in T1D, is generally well-tolerated but may cause gastrointestinal discomfort, such as bloating and gas. Other treatments like GLP-1 receptor agonists can lead to nausea, vomiting, and diarrhea. Overall, while butyrate shows promise in improving metabolic control, its side effects are relatively mild compared to traditional insulin therapy.

What prior FDA approvals exist?

The FDA has approved various treatments for Type 1 Diabetes, primarily focusing on insulin therapy and adjunctive treatments to improve glycemic control. While the provided context does not mention specific FDA approvals for butyrate or similar short-chain fatty acids for T1D, it does highlight ongoing research into butyrate's potential benefits. Current FDA-approved treatments for T1D include insulin sensitizers and other drugs that help manage blood glucose levels. For example, insulin therapy remains the cornerstone of T1D management, and other treatments like liraglutide, a GLP-1 receptor agonist, have been approved for use in children and adolescents with T1D to improve glycemic control when used alongside insulin.

What other types of research exist?

Promising novel alternatives to BKR-017 for Type 1 Diabetes patients include: 1) Glucagon-like peptide-1 (GLP-1) receptor agonists, which have shown potential in improving metabolic control and reducing inflammation. 2) Advanced basal insulin replacements, such as weekly GLP-1 receptor agonists like albiglutide, which have been compared favorably to daily insulin regimens. 3) Emerging therapies targeting gut microbiota modulation, such as specific probiotics and prebiotics, which can influence metabolic pathways and inflammation. These alternatives are in various stages of clinical trials and have shown potential benefits for metabolic control in diabetes.

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Butyrate Therapy for Type 1 Diabetes

Phase 1 & 2

Recruiting

Led By Adrian Vella, MD

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

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

Must have

All type 1 diabetes with C-Peptide (CPR) less than 0.5 ng/mL subjects who are > 20 and <80 years of age recruited from the Mayo Clinic Endocrinology Clinic

Will also meet HbA1c level of 6.4-8.9% and BMI of < 30 kg/m2 at week -4

Must not have

Except for the use of insulin, no other treatments for T1D will be permitted

Timeline

Screening 3 weeks

Treatment Varies

Follow Up (day 0) to day 28 and day 56

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new tablet called BKR-017, which delivers butyrate to the colon, in people with type 1 diabetes. The goal is to see if it helps improve blood sugar control and reduce triglycerides over a few months.

Who is the study for?

This trial is for adults aged 20-80 with Type 1 Diabetes, who are patients at the Mayo Clinic Endocrinology Clinic. They must have an HbA1c level of 6.4-8.9%, a BMI under 30, and low C-Peptide levels (<0.5 ng/mL). Participants cannot be on any T1D treatments other than insulin and must not be pregnant or unable to consent.

What is being tested?

The trial is testing BKR-017, which are butyrate tablets aimed at the colon, as an additional treatment to improve metabolic control in people with Type 1 Diabetes.

What are the potential side effects?

Potential side effects of BKR-017 may include digestive discomfort or changes in bowel habits due to its action on the gut; however, specific side effects will be monitored throughout the study.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am between 20 and 80 years old with type 1 diabetes and a C-Peptide level below 0.5 ng/mL.

Select...

My HbA1c is between 6.4-8.9% and my BMI is under 30.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I only use insulin to manage my Type 1 Diabetes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ (day 0) to day 28 and day 56

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~(day 0) to day 28 and day 56

This trial's timeline: 3 weeks for screening, Varies for treatment, and (day 0) to day 28 and day 56 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Insulin sensitivity

Secondary study objectives

Glucose Variability and Triglycerides

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Conventional Therapy / ButyrateExperimental Treatment1 Intervention

Subjects will be receiving usual therapy for the first study period (approx 1 month) then 500 mg Butyrate tablets to be taken at a dose of 1.5 g (3 tablets) twice daily (BID) for approx 2 months

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

BKR-017

2021

N/A

~80

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Type 1 Diabetes (T1D) primarily include insulin therapy, which replaces the insulin that the body can no longer produce, and helps regulate blood glucose levels. Emerging treatments, such as the use of butyrate (as in BKR-017), focus on improving metabolic control through anti-inflammatory properties and modulation of gut microbiota. Butyrate increases the production of glucose-regulating hormones like GLP-1 and PYY, which enhance insulin secretion and sensitivity. This is significant for T1D patients as it offers a potential adjunctive therapy to improve glycemic control and reduce inflammation, potentially leading to better overall management of the disease.

Effects of sodium butyrate on proliferation-dependent insulin gene expression and insulin release in glucose-sensitive RIN-5AH cells.Long-term drench of exopolysaccharide from Leuconostoc pseudomesenteroides XG5 protects against type 1 diabetes of NOD mice via stimulating GLP-1 secretion.Transcriptional regulation of genes encoding insulin, glucagon, and angiotensinogen by sodium butyrate in a rat islet cell line.