Type 1 Diabetes MellitusPhase 1NCT06272695
Glucagon Rescue of Insulin-Induced Hypoglycemia in Adults With Type 1 Diabetes Treated With Volagidemab
A Phase 1 study testing Volagidemab in people with Type 1 Diabetes Mellitus, run by REMD Biotherapeutics, Inc. at 2 sites in United States.
Trial summary
This trial is designed to evaluate the effect of glucagon receptor antagonism by volagidemab (once weekly) on glucose recovery from hypoglycemia after treatment with glucagon in adults with type 1 diabetes. Read more about this study
- Who is it for?
- Ages 18 to 72 years
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- Volagidemab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 Feb 2024to 1 Feb 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 72 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Receiving insulin for the treatment of documented diagnosis of T1DM for at least 2 years
- Body Mass Index (BMI) of 18.5 kg/m2 to 35.0 kg/m2
- On treatment with a stable insulin regimen for at least 8 weeks
- Currently using a continuous glucose monitoring (CGM) system
- HbA1c less than or equal to 10.0%
- Females of non-childbearing potential must be ≥1 year post-menopausal or documented as being surgically sterile. Females of childbearing potential must agree to use two methods of contraception during the entire study and for an additional 3 months after the end of dosing with the investigational product
- Male subjects must be willing to use clinically acceptable method of contraception during the entire study and for an additional 3 months after the end of the treatment period
- Other inclusion criteria may apply.
Who cannot join
- History of type 2 diabetes, maturity onset diabetes of the young (MODY), pancreatic surgery or chronic pancreatitis
- Pancreas, pancreatic islet cells, or renal transplant recipient
- T1DM treatment with any other antihyperglycemic drug (e.g., metformin, alpha- glucosidase inhibitors, SGLT-2 inhibitors, pramlintide, inhaled insulin, pre-mixed insulins, etc.) within 30 days of Day 1
- 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
- Myocardial infarction, unstable angina, revascularization procedure, or cerebrovascular accident ≤12 weeks
- Indication of liver disease
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- Current signs and symptoms of anemia
- Untreated eating disorders such as bulimia or anorexia nervosa
- History of pancreatitis, pancreatic neuroendocrine tumors or multiple endocrine neoplasia (MEN) or family history of MEN.
- Treatment with systemic corticosteroids within 30 days of Day 1, or planned initiation of such therapy during the study.
- Medical history of cancer or treatment for cancer in the last five years
- Women who are pregnant, nursing, or who plan to become pregnant while in the trial
- Other exclusion criteria may apply
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Altman Clinical and Translational Research Institute
San Deigo, California, 92037
Diablo Clinical Research
Walnut Creek, California, 94598
About this study
This trial is designed to evaluate the effect of glucagon receptor antagonism by volagidemab (once weekly) on glucose recovery from hypoglycemia after treatment with glucagon in adults with type 1 diabetes. After informed consent, Screening procedures to establish subject eligibility will be performed within a period of 28 days. Approximately 24 subjects with type 1 diabetes mellitus (T1DM) on stable doses of insulin will be enrolled.
After enrollment, subjects will undergo a baseline Hypoglycemia Recovery Procedure (with glucagon rescue). Subjects will then receive volagidemab subcutaneously (SC) once weekly for 6 weeks. At the end of the treatment phase, subjects will undergo a second Hypoglycemia Recovery Procedure. Subjects will be followed for 6 weeks after the last volagidemab dose with a final End-of-Study (EOS) visit during Week 12. The primary outcome will be the change in time to glucagon treatment success at Week 6 versus baseline.
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- Volagidemab
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VolagidemabBiological
Administered by SC injection once weekly for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| 35 mg Volagidemab | Experimental | Volagidemab 35 mg will be administered by subcutaneous (SC) injection once weekly for 6 weeks. Receives: Biological: Volagidemab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Time to glucagon treatment success at Week 6.
The primary outcome of the study is the change in time to glucagon treatment success, defined as an increase in plasma glucose of ≥20 mg/dL from the glucose nadir after receiving glucagon during insulin-induced hypoglycemia, from baseline to Week 6.
Measured: 6 weeks
Secondary outcomes (6)
Blood glucose response to glucagon rescue treatment during insulin-induced hypoglycemia.
Percentage of subjects achieving glucagon treatment success, defined as an increase in plasma glucose to ≥70 mg/dL or an increase of ≥20 mg/dL from the glucose nadir within 30 minutes of receiving glucagon during insulin-induced hypoglycemia, at Week 6.
Measured: 6 weeks
Treatment emergent adverse events (AEs)
The subject incidence rates of AEs will be tabulated by system organ class, preferred term, and severity grade for all treatment emergent, serious, treatment related, and serious treatment related AEs.
Measured: 12 weeks
Hypoglycemia symptoms - Edinburgh Hypoglycemia Scale
Results of the Edinburgh Hypoglycemia Scale will be summarized over Intent-to-Treat (ITT) set using descriptive statistics by visit (baseline, week 6) and timepoint (baseline, t = 15, 30, 45, and 60 min after glucagon administration for Edinburgh Hypoglycemia Scale). Changes from baseline in Edinburgh hypoglycemia scale will be summarized similarly.
Measured: 6 weeks
Hypoglycemia symptoms - Clarke Survey
Results of the Clarke Survey will be summarized over Intent-to-Treat (ITT) set using descriptive statistics by visit (baseline, week 6). Changes from baseline in Clarke Survey will be summarized similarly.
Measured: 6 weeks
Hypoglycemia symptoms - Gold Questionnaire
Results of the Gold Questionnaire will be summarized over Intent-to-Treat (ITT) set using descriptive statistics by visit (baseline, week 6). Changes from baseline in Gold Questionnaire will be summarized similarly.
Measured: 6 weeks
Change from baseline in hemoglobin A1c (HbA1c) at Week 6.
Change from baseline in hemoglobin A1c (HbA1c) at Week 6, after repeated doses of volagidemab
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2024
- Study start15 Feb 2024
- Primary completion1 Feb 2025
- Study completion1 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- REMD Biotherapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Zung Thai, MD, Study director, REMD Biotherapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06272695
- Sponsor's protocol ID
- R477-203
- Status last verified
- May 2025
- First submitted
- 15 Feb 2024
- Last updated
- 3 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glucagon Rescue of Insulin-Induced Hypoglycemia in Adults With Type 1 Diabetes Treated With Volagidemab
- ClinicalTrials.gov ID
- NCT06272695
- Acronym / sponsor ID
- R477-203
- Conditions
- Type 1 Diabetes Mellitus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- REMD Biotherapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Feb 2024 (actual)
- Primary completion
- 1 Feb 2025 (actual)
- Study completion
- 1 Feb 2025 (actual)
- First posted
- 22 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial is designed to evaluate the effect of glucagon receptor antagonism by volagidemab (once weekly) on glucose recovery from hypoglycemia after treatment with glucagon in adults with type 1 diabetes. After informed consent, Screening procedures to establish subject eligibility will be performed within a period of 28 days. Approximately 24 subjects with type 1 diabetes mellitus (T1DM) on stable doses of insulin will be enrolled.
After enrollment, subjects will undergo a baseline Hypoglycemia Recovery Procedure (with glucagon rescue). Subjects will then receive volagidemab subcutaneously (SC) once weekly for 6 weeks. At the end of the treatment phase, subjects will undergo a second Hypoglycemia Recovery Procedure. Subjects will be followed for 6 weeks after the last volagidemab dose with a final End-of-Study (EOS) visit during Week 12. The primary outcome will be the change in time to glucagon treatment success at Week 6 versus baseline.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 35 mg Volagidemab | Experimental | Biological: VolagidemabVolagidemab 35 mg will be administered by subcutaneous (SC) injection once weekly for 6 weeks. |
Who may qualify
- Ages
- 18 to 72 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Receiving insulin for the treatment of documented diagnosis of T1DM for at least 2 years
- Body Mass Index (BMI) of 18.5 kg/m2 to 35.0 kg/m2
- On treatment with a stable insulin regimen for at least 8 weeks
- Currently using a continuous glucose monitoring (CGM) system
- HbA1c less than or equal to 10.0%
Key exclusion criteria (13 listed)
- History of type 2 diabetes, maturity onset diabetes of the young (MODY), pancreatic surgery or chronic pancreatitis
- Pancreas, pancreatic islet cells, or renal transplant recipient
- T1DM treatment with any other antihyperglycemic drug (e.g., metformin, alpha- glucosidase inhibitors, SGLT-2 inhibitors, pramlintide, inhaled insulin, pre-mixed insulins, etc.) within 30 days of Day 1
- 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
- Myocardial infarction, unstable angina, revascularization procedure, or cerebrovascular accident ≤12 weeks
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VolagidemabAdministered by SC injection once weekly for 6 weeks | Biological | 35 mg Volagidemab |
Primary outcome
Change in Time to glucagon treatment success at Week 6.
Time frame: 6 weeks
The primary outcome of the study is the change in time to glucagon treatment success, defined as an increase in plasma glucose of ≥20 mg/dL from the glucose nadir after receiving glucagon during insulin-induced hypoglycemia, from baseline to Week 6.
6 secondary outcomes
Blood glucose response to glucagon rescue treatment during insulin-induced hypoglycemia.
Time frame: 6 weeks
Treatment emergent adverse events (AEs)
Time frame: 12 weeks
Hypoglycemia symptoms - Edinburgh Hypoglycemia Scale
Time frame: 6 weeks
Hypoglycemia symptoms - Clarke Survey
Time frame: 6 weeks
Hypoglycemia symptoms - Gold Questionnaire
Time frame: 6 weeks
Change from baseline in hemoglobin A1c (HbA1c) at Week 6.
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zung Thai, MD study director
REMD Biotherapeutics
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Volagidemab in people with Type 1 Diabetes Mellitus, run by REMD Biotherapeutics, Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Time to glucagon treatment success at Week 6. (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2025.