What side effects are associated with this type of intervention?

Common treatments for Type 1 Diabetes include insulin therapy, pramlintide, and newer investigational drugs like LY3532226. Insulin therapy, while essential, can cause hypoglycemia, weight gain, and injection site reactions. Pramlintide, used alongside insulin, may lead to nausea, vomiting, and a risk of severe hypoglycemia. LY3532226, which is being studied for its potential to modulate glucagon response to counteract hypoglycemia, aims to improve recovery from insulin-induced low blood sugar. However, specific side effects of LY3532226 are not yet well-documented. Broadly, treatments targeting glucagon response may also carry risks of gastrointestinal symptoms and hypoglycemia.

What prior FDA approvals exist?

The FDA has approved several treatments for Type 1 Diabetes (T1DM) that aim to manage blood glucose levels and counteract hypoglycemia. One notable treatment is the use of glucagon for emergency management of severe hypoglycemia. Additionally, insulin therapy remains the cornerstone of T1DM management. While the context does not provide specific FDA approvals for drugs similar to LY3532226, which modulates glucagon response, it is important to note that ongoing research, such as the study of LY3532226, aims to improve hypoglycemia management in T1DM by targeting glucagon responses.

What other types of research exist?

Promising alternatives to LY3532226 for Type 1 Diabetes patients include HM15136, a novel long-acting glucagon analogue, which has shown safety and efficacy in increasing blood glucose levels and has a long half-life suitable for weekly dosing. Additionally, dapagliflozin and ipragliflozin, both SGLT2 inhibitors, have demonstrated efficacy and safety as add-on therapies to insulin in Type 1 Diabetes patients, helping to improve glycemic control.

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Glucagon Receptor Antagonist

LY3532226 for Type 1 Diabetes

Phase 1

Waitlist Available

Research Sponsored by Eli Lilly and Company

Eligibility Criteria Checklist

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

Must have

Participants with type 1 diabetes mellitus (T1DM) for at least 2 years treated with insulin

Males or females not of childbearing potential

Must not have

Receipt of systemic or inhaled glucocorticoid therapy

Women of childbearing potential

Timeline

Screening 3 weeks

Treatment Varies

Follow Up predose up to 120 mins postdose

Awards & highlights

Summary

This trial tests if LY3532226 can help people with type 1 diabetes recover from low blood sugar caused by insulin by improving their body's glucagon response.

Who is the study for?

This trial is for adults with Type 1 Diabetes Mellitus (T1DM) who have been managing their condition with insulin for at least two years. They should have a BMI between 18.5 to 40 kg/m² and not be able to bear children. Those recently in other studies, on certain diabetes medications, or using steroids can't participate.

What is being tested?

The study tests LY3532226's effect on glucagon response during insulin-induced low blood sugar in T1DM patients compared to a placebo. It aims to see if the drug helps recover from low blood sugar better than no treatment over about four months.

What are the potential side effects?

Potential side effects of LY3532226 are not detailed here but may include reactions similar to other diabetes treatments such as hypoglycemia, nausea, headache, or allergic responses.

Eligibility Criteria

Inclusion Criteria

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

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I have had type 1 diabetes for over 2 years and am on insulin.

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I am not able to have children.

Exclusion Criteria

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

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I am currently taking or have taken steroid medication.

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I am a woman who could become pregnant.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ predose up to 120 mins postdose

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~predose up to 120 mins postdose

This trial's timeline: 3 weeks for screening, Varies for treatment, and predose up to 120 mins postdose for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Pharmacodynamics (PD): Area under the concentration versus time curve from time 60 to 120 minutes (AUC60-120min) of plasma glucagon during the insulin-induced hypoglycemia

Secondary study objectives

Change from Baseline in Fasting and Post meal Glucose during Standardized Mixed-meal Tolerance Test (sMMTT)

Change from Baseline in Glucagon Concentration at Fasting and Post meal during sMMTT

The amount of exogenous glucose infused to maintain a plasma glucose level of >2.5 millimole per liter (mmol/L), after the insulin infusion is terminated.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: LY3532226Experimental Treatment1 Intervention

Group II: PlaceboPlacebo Group1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

LY3532226

2023

Completed Phase 1

~170

0 / 4Eligibility 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 treatments for Type 1 Diabetes (T1DM) include insulin therapy and glucagon modulation. Insulin therapy is essential as it replaces the insulin that the pancreas cannot produce, helping to regulate blood glucose levels and prevent hyperglycemia. Glucagon modulation, such as the potential effects of LY3532226, aims to enhance the body's natural glucagon response to low blood sugar levels, addressing hypoglycemia. This is particularly important for T1DM patients who are at risk of severe hypoglycemic episodes due to insulin therapy. By improving the glucagon response, treatments like LY3532226 could help maintain balanced blood glucose levels, reducing the risks associated with both hyperglycemia and hypoglycemia.