GRA (REMD-477) for Type 1 Diabetes

Overseen By Todd May

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of California, San Diego

Must be taking: Insulin

Must not be taking: Other diabetes medications

Disqualifiers: Pancreatitis, Liver disease, Anemia, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 17

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a new treatment, REMD-477, affects people with Type 1 diabetes. The researchers aim to determine if this drug can improve insulin use, reduce heart health risks, and influence energy use and ketone levels. Participants will receive weekly injections for 12 weeks and undergo various tests before and after treatment. Ideal candidates have had Type 1 diabetes for over five years, use an insulin pump and a continuous glucose monitor, and maintain stable blood sugar levels. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important advancements in diabetes care.

Do I have to stop taking my current medications for the trial?

If you are currently using diabetes medications other than insulin, you will need to stop them at least one month before the trial. The trial requires participants to be on a stable insulin regimen.

Is there any evidence suggesting that REMD-477 is likely to be safe for humans?

Research has shown that REMD-477, a medication that blocks a specific hormone, is generally safe for people with Type 1 diabetes. Studies have found that it can reduce the need for insulin without causing serious side effects. Notably, earlier research reported no major health issues. This suggests that REMD-477 is safe for humans so far. However, like most treatments, some minor side effects might occur. Overall, REMD-477 appears promising in terms of safety based on current evidence. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for Type 1 diabetes?

Unlike the standard treatments for Type 1 Diabetes, which often include insulin therapy and continuous glucose monitoring, REMD-477 offers a novel approach by targeting the hormone glucagon. Researchers are excited about REMD-477 because it uses a once-weekly subcutaneous injection that aims to stabilize blood sugar levels by blocking glucagon receptors, potentially reducing the need for frequent insulin adjustments. This unique mechanism not only promises to simplify the management of diabetes but may also improve overall glucose control, leading to better long-term outcomes for patients.

What evidence suggests that REMD-477 might be an effective treatment for Type 1 diabetes?

Research has shown that REMD-477, a medication that blocks certain signals in the body, can help people with Type 1 diabetes. In this trial, participants in the GRA (REMD-477) Group will receive once-weekly subcutaneous injections of 70mg REMD-477. Studies have found that REMD-477 allows patients to use less insulin while maintaining stable blood sugar levels. Specifically, those who took REMD-477 required less daily insulin and achieved better blood sugar control. Importantly, this improvement did not increase the risk of low blood sugar (hypoglycemia). These findings suggest that REMD-477 could be a helpful treatment for managing Type 1 diabetes. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Your kidney function is normal.

Your HbA1c level is less than or equal to 8.5% at the time of screening.

I weigh at least 50kg.

Exclusion Criteria

Any other condition(s) that might reduce the chance of obtaining study data, or that might cause safety concerns, or that might compromise the ability to give truly informed consent

History or evidence of clinically-significant disorder or condition that, in the opinion of the Investigator, would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion

I have used diabetes medication other than insulin in the last month.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Baseline

Participants complete cardiovascular tests, hyperinsulinemic/euglycemic clamp, and insulin withdrawal challenge

1 week

3 visits (in-person)

Treatment

Participants receive weekly injections of REMD-477 or placebo and undergo various assessments

12 weeks

12 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• REMD-477

Trial Overview 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.

How Is the Trial Designed?

Group I: GRA (REMD-477) Group Experimental Treatment 1 Intervention

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

Group II: Placebo Group Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

University of California, San Diego

Lead Sponsor

Trials

1,215

Recruited

1,593,000+

REMD Biotherapeutics, Inc.

Industry Sponsor

Trials

7

Recruited

320+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/29283470/

Effect of a glucagon receptor antibody (REMD-477) in type 1 ... Glucagon receptor antagonism decreases insulin requirements and improves glycaemic control in patients with type 1 diabetes.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03117998

NCT03117998 | Multiple Dose Study to Evaluate the ... This study will determine whether REMD-477 can decrease daily insulin requirements and improve glycemic control after 12 weeks of treatment.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6181222/

Effect of a Glucagon Receptor Antibody (REMD-477) in ... We found a single dose of REMD-477 decreased insulin requirements and improved glycemic control, without an increase in hypoglycemia or adverse ...

4. biospace.com biospace.com/phase-i-clinical-study-results-of-remd-biotherapeutics-lead-product-candidate-remd-477-demonstrate-reduced-need-for-insulin-and-improved-blood-gluc

Phase I Clinical Study Results Of REMD Biotherapeutics ... The results showed that a single dose of REMD-477 substantially reduced daily insulin requirements and glucose levels without increasing ...

5. clinicaltrials.ucsd.edu clinicaltrials.ucsd.edu/trial/NCT04779645

UCSD Diabetes Trial → GRA in Patients With Type 1 This study will examine the effects a Glucagon Receptor Antagonist (GRA), has on Insulin Sensitivity, Cardiovascular risks (CVD), and Ketone body formation ...

6. dom-pubs.onlinelibrary.wiley.com dom-pubs.onlinelibrary.wiley.com/doi/abs/10.1111/dom.13202

Effect of a glucagon receptor antibody (REMD‐477) in type 1 ... The aim of the current study (Clinical trial reg. no. NCT02715193, clinicaltrials.gov) was to study the efficacy and safety of REMD-477, ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT02715193

Single-dose Study to Evaluate Safety, Tolerability, and ... This is a randomized, placebo-controlled, double-blind study to evaluate safety, tolerability and pharmacodynamics of REMD-477 in subjects who have Type 1 ...