What side effects are associated with this type of intervention?

Common treatments for Type 1 Diabetes include insulin therapy and emerging treatments like Glucagon Receptor Antagonists (GRAs). Insulin therapy can cause side effects such as hypoglycemia, weight gain, and injection site reactions. GRAs, such as REMD-477, are being studied for their effects on insulin sensitivity and cardiovascular risks. Potential side effects of GRAs may include changes in ketone body formation and other metabolic parameters, but more research is needed to fully understand their safety profile.

What prior FDA approvals exist?

Currently, there is no specific mention of FDA approvals for Glucagon Receptor Antagonists (GRAs) like REMD-477 for the treatment of Type 1 Diabetes in the provided context. However, the primary treatments for Type 1 Diabetes typically include insulin therapy and adjunctive treatments aimed at improving glycemic control. For instance, insulin analogs and continuous glucose monitoring systems are commonly used. Broader treatment options also include lifestyle interventions and other pharmacologic agents aimed at optimizing blood glucose levels.

What other types of research exist?

Promising, novel alternatives to REMD-477 for Type 1 Diabetes patients include Glucagon-Like Peptide-1 Receptor Agonists (GLP-1 RAs) such as taspoglutide and SKL-18287.

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Glucagon Receptor Antagonist

GRA (REMD-477) for Type 1 Diabetes

Phase 2

Waitlist Available

Research Sponsored by University of California, San Diego

Eligibility Criteria Checklist

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

Must have

Men and women between the ages of 18 and 65 years old, inclusive, at the time of screening

A minimum weight of 50kg

Must not have

Unable or unwilling to follow the study protocol or who are non-compliant with screening appointments or study visits

Women who are pregnant or lactating/breastfeeding

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12-weeks

Awards & highlights

Summary

This trial tests a drug called REMD-477, which blocks a hormone that raises blood sugar, in people with Type 1 diabetes. The goal is to see if it helps with insulin sensitivity and heart health. Participants will receive the drug for several months while continuing their usual insulin therapy. REMD-477 is being tested for its effectiveness in type 1 diabetes.

Who is the study for?

This trial is for men and women aged 18-65 with Type 1 diabetes for over 5 years, using a CGM system, HbA1c ≤ 8.5%, and on a stable insulin regimen via pump. Participants must use contraception and have an eGFR ≥60 mL/min/1.73m². Excluded are those with pancreatitis, liver disease, other significant health risks or recent non-insulin diabetes meds usage.

What is being tested?

The study tests the effects of REMD-477 (a Glucagon Receptor Antagonist) on insulin sensitivity, cardiovascular risk factors, and ketone body formation in Type 1 diabetics compared to placebo over a period of 12 weeks with prior and post-treatment evaluations including blood tests.

What are the potential side effects?

Potential side effects may include changes in blood sugar levels that could affect diabetes management, possible impacts on liver function due to the drug's mechanism of action as it targets glucagon receptors which play a role in glucose metabolism.

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 65 years old.

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I weigh at least 50kg.

Exclusion Criteria

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

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I am willing and able to follow the study rules and attend all appointments.

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I am not pregnant or breastfeeding.

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I have been diagnosed with anemia that affects my daily life.

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I have a history of pancreatitis, thyroid cancer, or liver disease.

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

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

Primary study objectives

Change in Beta-hydroxybutyrate (BHB) Level

Change in Cardiovascular Disease (CVD) Risk Markers.

Change in Free Fatty Acid (FFA) Level

+5 more

Side effects data

From 2021 Phase 2 trial • 154 Patients • NCT03117998

16%

Upper respiratory tract infection

16%

Headache

12%

Aspartate aminotransferace increased

12%

Nausea

12%

Alanine aminotransferace increased

Hypoglycaemia

Anemia

Cough

Diarrhoea

Oropharyngeal pain

Vomiting

100%

80%

60%

40%

20%

Study treatment Arm

Part A - 35 mg REMD-477

Part A - 70 mg REMD-477

Part A - Matching Placebo

Part B - 35 mg REMD-477

Part B - 70 mg REMD-477

Part B - Matching Placebo

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: GRA (REMD-477) GroupExperimental Treatment1 Intervention

Once weekly, subcutaneous injection of 70mg REMD-477 (in 1 mL solution) for up to 12 weeks.

Group II: Placebo GroupPlacebo Group1 Intervention

Once weekly, subcutaneous injection of 1mL saline solution for up to 12 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Volagidemab

Not yet FDA approved

0 / 6Eligibility 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 primary treatment for Type 1 Diabetes is insulin therapy, which involves administering exogenous insulin to manage blood glucose levels, as the body cannot produce insulin due to autoimmune destruction of pancreatic beta cells. Insulin therapy is crucial for preventing hyperglycemia and its associated complications. Another emerging treatment is the use of Glucagon Receptor Antagonists (GRAs), such as REMD-477, which work by blocking the glucagon receptor, thereby reducing hepatic glucose production and improving insulin sensitivity. This is particularly important for Type 1 Diabetes patients as it offers a potential adjunctive therapy to insulin, aiming to achieve better glycemic control and reduce the risk of complications.

The anti-inflammatory and immunological properties of GLP-1 Receptor Agonists.The Role of GLP-1 Signaling in Hypoglycemia due to Hyperinsulinism.Changing paradigms in type 2 diabetes mellitus.