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Glucagon Receptor Antagonist

35 mg Volagidemab for Type 1 Diabetes

Phase 1

Recruiting

Research Sponsored by REMD Biotherapeutics, Inc.

Eligibility Criteria Checklist

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

Must have

Receiving insulin for the treatment of documented diagnosis of T1DM for at least 2 years

On treatment with a stable insulin regimen for at least 8 weeks

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks

Awards & highlights

Study Summary

This trial will test how a new drug called volagidemab affects glucose recovery from low blood sugar in adults with type 1 diabetes. Participants will receive the drug once a week for 6

Who is the study for?

This trial is for adults with Type 1 Diabetes who are on stable insulin doses. They must be able to give informed consent and go through a screening process within 28 days before starting the trial. People with other health conditions that could interfere with the study or those unable to follow its procedures may not qualify.Check my eligibility

What is being tested?

The trial tests how well volagidemab, given once weekly by injection, helps recover from low blood sugar when treated with glucagon in people with Type 1 Diabetes. It involves initial and final hypoglycemia recovery procedures over a span of 12 weeks.See study design

What are the potential side effects?

Potential side effects of volagidemab are not specified here but generally can include reactions at the injection site, possible changes in blood sugar levels, and any individual sensitivities to the medication.

Eligibility Criteria

Inclusion Criteria

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

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I have been taking insulin for Type 1 diabetes for at least 2 years.

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I have been on a consistent insulin treatment for at least 8 weeks.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Time to glucagon treatment success at Week 6.

Secondary outcome measures

Blood glucose response to glucagon rescue treatment during insulin-induced hypoglycemia.

Change from baseline in hemoglobin A1c (HbA1c) at Week 6.

Hypoglycemia symptoms - Clarke Survey

+3 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

1Treatment groups

Experimental Treatment

Group I: 35 mg VolagidemabExperimental Treatment1 Intervention

Volagidemab 35 mg will be administered by subcutaneous (SC) injection once weekly for 6 weeks.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

REMD Biotherapeutics, Inc.Lead Sponsor

6 Previous Clinical Trials

296 Total Patients Enrolled

Zung Thai, MDStudy DirectorREMD Biotherapeutics

5 Previous Clinical Trials

756 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the Food and Drug Administration granted approval for the use of 35 milligrams of Volagidemab?

"Given that this is a Phase 1 trial with minimal safety and efficacy data, Volagidemab at the dose of 35 mg was rated as a level 1 in terms of safety by our team."

Answered by AI

Are there ongoing efforts to enlist individuals for participation in this current research study?

"Indeed, the details on clinicaltrials.gov demonstrate that this trial is actively pursuing candidates. The trial was originally posted on February 29th, 2024, and its most recent update was made on February 15th, 2024. This study aims to recruit a total of 24 participants from two distinct locations."

Answered by AI