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Glucagon Receptor Antagonist
Volagidemab for Low Blood Sugar in 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
Must not have
History of type 2 diabetes, maturity onset diabetes of the young (MODY), pancreatic surgery or chronic pancreatitis
Occurrence of severe hypoglycemia involving coma and/or seizure that required hospitalization or hypoglycemia-related treatment by an emergency physician or paramedic within 3 months prior to Day 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights
No Placebo-Only Group
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.
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.
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 belowSelect...
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a history of type 2 diabetes, MODY, pancreatic surgery, or chronic pancreatitis.
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I've had a severe low blood sugar episode that needed hospital care in the last 3 months.
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I have received a pancreas, pancreatic islet cells, or kidney transplant.
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I haven't taken steroids in the last 30 days and don't plan to start during the study.
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I have a liver condition.
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I am experiencing symptoms of anemia.
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I have a history of pancreatitis, pancreatic tumors, or MEN in my family.
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I am not pregnant, nursing, or planning to become pregnant during the trial.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Time to glucagon treatment success at Week 6.
Secondary study objectives
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 moreSide effects data
From 2021 Phase 2 trial • 154 Patients • NCT0311799816%
Upper respiratory tract infection
16%
Headache
12%
Aspartate aminotransferace increased
12%
Nausea
12%
Alanine aminotransferace increased
8%
Hypoglycaemia
8%
Anemia
8%
Cough
8%
Diarrhoea
4%
Oropharyngeal pain
4%
Vomiting
100%
80%
60%
40%
20%
0%
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
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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.
Find a Location
Who is running the clinical trial?
REMD Biotherapeutics, Inc.Lead Sponsor
6 Previous Clinical Trials
296 Total Patients Enrolled
2 Trials studying Diabetes
96 Patients Enrolled for Diabetes
Zung Thai, MDStudy DirectorREMD Biotherapeutics
5 Previous Clinical Trials
756 Total Patients Enrolled