This study is testing VV-14300 in adults with long-standing type 1 diabetes (T1D) whose blood sugar is not well controlled despite using an automated insulin delivery (AID) system. VV-14300 is an investigational gene therapy that is injected into muscle and is designed to help remove excess sugar from the blood.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
29
VV-14300 will be administered via ultrasound-guided intramuscular injections
Kriya Clinical Trial Site
Toronto, Canada
Kriya Clinical Trial Site
Christchurch, New Zealand
Incidence and severity of adverse events, abnormal clinical laboratory values, abnormal physical exams, and abnormal vital signs
Safety of VV-14300
Time frame: 52 Weeks
Change from Baseline in blood glucose by as measured by continuous glucose monitoring (CGM)
Efficacy of VV-14300 (Part 1)
Time frame: 8 Weeks
Change from Baseline in blood glucose as measured by hemoglobin A1c (HbA1c) level
Efficacy of VV-14300 (Part 1)
Time frame: 8 Weeks
Change from Baseline in blood glucose as measured by fructosamine level
Efficacy of VV-14300 (Part 1)
Time frame: 8 Weeks
Change from Baseline in blood glucose as measured by mixed meal tolerance test (MMTT)
Efficacy of VV-14300 (Part 1)
Time frame: 8 Weeks
Mean change from Baseline in HbA1c
Efficacy of VV-14300 (Part 2)
Time frame: 26 Weeks
Mean change from Baseline in HbA1c
Efficacy of VV-14300
Time frame: 16, 26 (Part 1), and 52 Weeks
Change from Baseline in glucose time-in-range derived from CGM data
Efficacy of VV-14300
Time frame: 52 Weeks
Change from Baseline in mean glucose concentration derived from CGM data
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Efficacy of VV-14300
Time frame: 52 Weeks
Change from Baseline in Glucose Management Indicator (GMI) derived from CGM data
Efficacy of VV-14300
Time frame: 52 Weeks
Change from Baseline in glycemic variability (coefficient of variation) derived from CGM data
Efficacy of VV-14300
Time frame: 52 Weeks
Change from Baseline in total daily insulin dose (basal and bolus)
Efficacy of VV-14300
Time frame: 52 Weeks
Change from Baseline in blood glucose by mixed meal tolerance test (MMTT)
Efficacy of VV-14300
Time frame: 52 Weeks
Change from Baseline in blood glucose by fructosamine level
Efficacy of VV-14300
Time frame: 52 Weeks
Change from Baseline in Diabetes Medication Satisfaction Tool (DMSAT) score
Patient-reported outcomes for VV-14300
Time frame: 52 Weeks
Change from Baseline in 8-item Type 1-Diabetes Distress Assessment System (T1-DDAS) Core Scale score
Patient-reported outcomes for VV-14300
Time frame: 52 Weeks
Change from Baseline in Wellbeing Index (WHO-5 questionnaire) score
Patient-reported outcomes for VV-14300
Time frame: 52 Weeks
Change from Baseline in Hypoglycemia Fear Survey-II Short Form (HFS-II-SF) score
Patient-reported outcomes for VV-14300
Time frame: 52 Weeks
Change from Baseline in quality-of-life measures as assessed by qualitative interviews
Identification of key quality-of-life themes using semi-structured qualitative interviews to assess patient experiences with the disease and treatment
Time frame: 52 weeks
Change from Baseline in body weight
Safety of VV-14300
Time frame: 52 Weeks
Change from Baseline in fasting lipid levels
Safety of VV-14300
Time frame: 52 Weeks
Change from Baseline in the level of antibodies to AAV vector capsid and VV-14300-expressed transgene product by enzyme-linked immunosorbent assay (ELISA)
Humoral immune response to VV-14300
Time frame: 52 Weeks
Change from Baseline in interferon-gamma cellular immune response to AAV1 capsid and VV-14300-expressed transgene product by enzyme-linked immunosorbent spot (ELISpot) assay
Cellular immune response to VV-14300
Time frame: 52 Weeks
VV-14300 vector levels in biological samples
Vector shedding of VV-14300 in serum, nasal mucus, urine, semen, feces, saliva (Part 1)
Time frame: 52 Weeks