Type 1 Diabetes Mellitus study: VV-14300
Official title VV-14300 for the Treatment of Type 1 Diabetes
ClinicalTrials.gov ID: NCT07831798
What this study is testing
What is VV-14300?
VV-14300 is an investigational gene therapy being studied as a potential treatment for adults with long‑standing type 1 diabetes whose blood sugar is not well controlled despite using an automated insulin delivery system.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to see if VV‑14300 can help lower blood sugar in people with type 1 diabetes who have not achieved good control with their current insulin delivery system.
- Who it's for
- Adults with long‑standing type 1 diabetes whose blood sugar remains high even when using an automated insulin delivery system.
- What's involved
- Participants will receive an injection of the gene therapy into muscle and will have regular blood tests and clinic visits to monitor safety and blood sugar levels.
- Time commitment
- The study lasts several months, with multiple clinic visits and blood tests scheduled throughout the period.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- Able to provide signed informed consent.
- 18 to 65 years of age (inclusive) at Screening.
- Body mass index (BMI) of 20.0 to \<30.0 kg/m².
- Clinical diagnosis of Type 1 Diabetes for at least 5 years prior to Screening, currently managed with an Automated Insulin Delivery (AID) system for...
- Suboptimal glycemic control (HbA1c \>7% and \<10%), and on a stable insulin regimen at Screening.
You likely can't join if
- Type 2 diabetes or other condition requiring exogenous insulin that is not due to autoimmunity, or when insulin delivery is not managed through an...
- Diabetic complications (e.g., severe/proliferative retinopathy or neuropathy) or a clinically significant medical, cognitive, or psychiatric...
- Recurrent diabetic ketoacidosis (2 or more events in the 12 months prior to Screening).
- Pregnant or breastfeeding.
- History of malignancy requiring chemotherapy and/or radiation within the 12 months prior to Screening, except for successfully treated non-melanoma...
- Clinically significant cardiovascular or cerebrovascular disease, uncontrolled blood pressure, family history of Long QT syndrome, or clinically...
See the full eligibility criteria
- Able to provide signed informed consent.
- 18 to 65 years of age (inclusive) at Screening.
- Body mass index (BMI) of 20.0 to \<30.0 kg/m².
- Clinical diagnosis of Type 1 Diabetes for at least 5 years prior to Screening, currently managed with an Automated Insulin Delivery (AID) system for at least 3 months prior to Screening.
- Suboptimal glycemic control (HbA1c \>7% and \<10%), and on a stable insulin regimen at Screening.
- Adequate kidney function (estimated glomerular filtration rate [eGFR] \>60 mL/min/1.73m²) at Screening.
- Females of child-bearing potential must have a negative pregnancy test at Screening and prior to dosing
- Agree to refrain from donating blood, plasma, platelets, eggs, or sperm during the 12-month Post-Treatment Follow-up Period.
- Willing and able to complete all study visits, procedures, and required use of study-provided monitoring devices for the duration of the study.
- Type 2 diabetes or other condition requiring exogenous insulin that is not due to autoimmunity, or when insulin delivery is not managed through an AID system.
- Diabetic complications (e.g., severe/proliferative retinopathy or neuropathy) or a clinically significant medical, cognitive, or psychiatric condition that, in the Investigator's opinion, poses additional risk or would...
- Recurrent diabetic ketoacidosis (2 or more events in the 12 months prior to Screening).
- Pregnant or breastfeeding.
- History of malignancy requiring chemotherapy and/or radiation within the 12 months prior to Screening, except for successfully treated non-melanoma skin cancers (e.g., basal cell, squamous cell carcinomas), cervical...
- Clinically significant cardiovascular or cerebrovascular disease, uncontrolled blood pressure, family history of Long QT syndrome, or clinically significant ECG abnormality.
- Significant history of alcohol or drug abuse, or positive alcohol breath test or urine drug screen at the Screening or Run-in visit.
- Plans to implement new strenuous physical activity (e.g., significantly increased running pace/duration, high-intensity interval training, heavy weightlifting, vigorous cycling) during the study.
- Impaired awareness of hypoglycemia.
- Active hepatitis B or C infection, positive HIV serology, or any latent or active infection that would interfere with study procedures or be exacerbated by study medications.
- Clinically significant abnormal Screening laboratory or other diagnostic findings (including hepatic, hematologic, thyroid, muscle-enzyme, or tuberculosis screening) rendering the participant unsuitable for the study.
- Current or recent use of medications that could interfere with glucose metabolism or confound study assessments (e.g., glucocorticoids, systemic beta-blockers, growth hormone, or other antidiabetic medications [e.g...
- Vaccination within 30 days prior to dosing or planned vaccination within 8 weeks post-dosing.
- Known hypersensitivity to tocilizumab, or Screening laboratory findings indicating undue risk of a tocilizumab-related adverse event.
- History of bariatric surgery within the 12 months prior to Screening.
- History of trauma to, or other findings affecting the suitability of, the muscles intended for study intervention administration.
- Participation in another investigational drug or biologic trial within 6 months prior to Screening, or participation in any previous gene therapy trial
The study team makes the final eligibility decision.
Where it is enrolling
- Toronto, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Toronto, Canada. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.