What side effects are associated with this type of intervention?

The most common treatment for Type 1 Diabetes is insulin therapy, which can cause side effects such as hypoglycemia, weight gain, and injection site reactions. Adjunctive treatments like GLP-1 receptor agonists (e.g., liraglutide) may lead to gastrointestinal symptoms such as nausea and vomiting, and have been associated with a risk of pancreatitis. SGLT2 inhibitors (e.g., dapagliflozin) can cause urinary tract infections, genital infections, and a slight increase in the risk of diabetic ketoacidosis. These treatments aim to improve glycemic control but require careful management to avoid adverse effects.

What prior FDA approvals exist?

The FDA has approved various treatments for Type 1 Diabetes, primarily focusing on insulin therapies. These include rapid-acting, long-acting, and premixed insulin formulations to manage blood glucose levels. While GLP-1 receptor agonists and SGLT2 inhibitors are primarily used for Type 2 Diabetes, ongoing trials are exploring their potential benefits in Type 1 Diabetes. For instance, semaglutide, a potent GLP-1RA, is being studied in combination with dapagliflozin to improve glycemic control without increasing hypoglycemia risk. However, no specific FDA-approved drugs currently enhance the physiological response to hypoglycemia in Type 1 Diabetes.

What other types of research exist?

Promising novel alternatives for Type 1 Diabetes patients in 2024 include hybrid closed-loop (HCL) systems, which have demonstrated improved glycemic outcomes in real-world settings. Additionally, advancements in GLP-1 receptor agonists may offer potential benefits in glucose regulation, although their primary use is in Type 2 Diabetes. These technologies and treatments represent significant progress in managing T1D and enhancing the physiological response to hypoglycemia.

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GPR119 Agonist

GPR119 Agonist for Type 1 Diabetes (PHROG Trial)

Phase 2

Waitlist Available

Led By Richard Pratley, MD

Research Sponsored by Translational Research Institute for Metabolism and Diabetes, Florida

Eligibility Criteria Checklist

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

Must have

Healthy subject cohort: Age >20 years

Healthy subject cohort: No history of diabetes

Must not have

History of HIV, active Hepatitis B or C, or Tuberculosis

Additional exclusion Criteria for type 1 diabetes cohort: Two or more episode of severe hypoglycemia per month in the past six months

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 14, day 42

Summary

This trial is testing a new medication to help people with type 1 diabetes respond better to low blood sugar. The study will look at how people with diabetes react.

Who is the study for?

This trial is for adults over 20 with Type 1 Diabetes Mellitus (T1DM) who've had the condition for more than 5 years and require insulin. They must not plan to conceive during the study. Healthy adults are also needed as a reference group, without diabetes or significant health issues. Participants should not have a history of substance abuse, psychiatric conditions affecting protocol adherence, or severe medical conditions.

What is being tested?

The study tests if MBX-2982, a GPR119 agonist, can improve the body's response to low blood sugar in people with T1DM compared to placebo or no medication at all. The effects will be measured against responses from healthy individuals.

What are the potential side effects?

Potential side effects aren't specified but could include reactions typical of diabetes medications such as hypoglycemia (very low blood sugar), digestive disturbances, skin reactions at injection sites, and possible allergic reactions.

Eligibility Criteria

Inclusion Criteria

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

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I am over 20 years old.

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I have never been diagnosed with diabetes.

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My kidneys are functioning well, with a creatinine clearance rate above 80 mL/min.

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I have Type 1 diabetes and need insulin to live.

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I am over 20 years old and have Type 1 diabetes.

Exclusion Criteria

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

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I have a history of HIV, Hepatitis B or C, or Tuberculosis.

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I have had two or more severe low blood sugar episodes per month in the last six months.

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I haven't started or changed any hormone therapy in the last 3 months.

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I only use insulin to manage my type 1 diabetes.

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My BMI is either above 30 or below 18.5.

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I have only been diagnosed with type 1 diabetes, not type 2 or any other form.

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I have had an organ transplant.

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My liver enzymes are not more than 2.5 times the normal limit.

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I do not have any mental health conditions that would stop me from following the study's requirements.

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I haven't taken medications affecting my metabolism in the last 3 months.

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I have had weight loss surgery in the past.

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I am not on insulin treatment.

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My blood pressure is not controlled with 2 or fewer medications.

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My kidney function is impaired.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 14, day 42

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 14, day 42

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 14, day 42 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Incremental AUC for Glucagon During Hypoglycemia (Above Baseline Levels During Euglycemia)

Maximal Glucagon Concentration During Hypoglycemia

Total Area Under the Curve (AUC) for Glucagon During Hypoglycemia.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Placebo first then MBX-2982- Volunteers with Type 1 diabetesExperimental Treatment2 Interventions

Participants with type 1 diabetes (T1D) will be randomized to either study medication or placebo group. In this arm, participants will receive a pill that does not contain the medication (placebo). This will be followed by a wash-out period and a cross over to the second study period in which they will receive a pill that contains the study medication (MBX-2982).

Group II: MBX-2982 first then placebo- Volunteers with Type 1 diabetesExperimental Treatment2 Interventions

Participants with type 1 diabetes (T1D) will be randomized to either study medication or placebo group. In this arm, participants will receive a pill that contains the study medication (MBX-2982). This will be followed by a wash-out period and a cross over to the second study period in which they will receive a pill that does not contain the medication (placebo).

Group III: Healthy VolunteersActive Control1 Intervention

This group will not receive any medication. It will be studied to establish the norm of the measurement that will be performed to obtain the study outcomes.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Placebo

1995

Completed Phase 3

~2670

Study Medication (MBX-2982)

2021

Completed Phase 2

~110

0 / 19Eligibility 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

The most common treatment for Type 1 Diabetes is insulin therapy, which involves administering exogenous insulin to replace the insulin that the pancreas can no longer produce. This is essential for regulating blood glucose levels and preventing hyperglycemia. Emerging treatments, such as immune-based therapies, aim to preserve or restore pancreatic beta-cell function, potentially reducing the need for exogenous insulin. Enhancing the physiological response to hypoglycemia, as studied in some research medications, is particularly important for T1DM patients because it helps prevent severe hypoglycemia, a dangerous complication that can occur with insulin therapy. This enhancement can improve safety and quality of life for patients by reducing the risk of hypoglycemic episodes.

Hypoglycaemia: Still the main drawback of insulin 100 years on: "From man to mouse".Progress in the development of immune-based therapies for type 1 diabetes mellitus.