This study is testing VV-14299 and VV-14300 or VV-14300 alone 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-14299 and VV-14300 are investigational gene therapies that are injected into muscle and are designed to work together to help remove excess sugar from the blood.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
29
Kriya Clinical Trial Site
Melbourne, Australia
Incidence and severity of adverse events, abnormal clinical laboratory values, abnormal physical exams, and abnormal vital signs
Safety of VV-14299 and/or VV-14300
Time frame: 52 Weeks
Change from Baseline in blood glucose as measured by continuous glucose monitoring (CGM)
Efficacy of VV-14299 and/or VV-14300 (Part 1)
Time frame: 16 Weeks
Change from Baseline in blood glucose as measured by hemoglobin A1c (HBA1c) level
Efficacy of VV-14299 and/or VV-14300 (Part 1)
Time frame: 16 Weeks
Change from Baseline in blood glucose as measured by fructosamine level
Efficacy of VV-14299 and/or VV-14300 (Part 1)
Time frame: 16 Weeks
Change from Baseline in blood glucose as measured by mixed meal tolerance test (MMTT)
Efficacy of VV-14299 and/or VV-14300 (Part 1)
Time frame: 16 Weeks
Mean change from Baseline in HbA1c levels
Efficacy of VV-14299 and/or VV-14300 (Part 2)
Time frame: 26 Weeks
Mean change from Baseline in HbA1c levels
Efficacy of VV-14299 and/or VV-14300
Time frame: 16, 26 (Part 1), and 52 Weeks
Change from Baseline in time-in-range derived from CGM data
Efficacy of VV-14299 and/or VV-14300
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Time frame: 52 Weeks
Change from Baseline in mean glucose concentration derived from CGM data
Efficacy of VV-14299 and/or VV-14300
Time frame: 52 Weeks
Change from Baseline in Glucose Management Indicator (GMI) derived from CGM data
Efficacy of VV-14299 and/or VV-14300
Time frame: 52 Weeks
Change from Baseline in glycemic variability (coefficient of variation) derived from CGM data
Efficacy of VV-14299 and/or VV-14300
Time frame: 52 Weeks
Change from Baseline in total daily insulin dose (basal and bolus)
Efficacy of VV-14299 and/or VV-14300 (insulin-sparing effect)
Time frame: 52 Weeks
Change from Baseline in average insulin boluses per day
Efficacy of VV-14299 and/or VV-14300 (insulin-sparing effect)
Time frame: 52 Weeks
Change from Baseline in blood glucose by mixed meal tolerance test (MMTT)
Efficacy of VV-14299 and/or VV-14300
Time frame: 52 Weeks
Change from Baseline in blood glucose by fructosamine level
Efficacy of VV-14299 and/or VV-14300
Time frame: 52 Weeks
Change from Baseline in body weight
Safety of VV-14299 and/or VV-14300
Time frame: 52 Weeks
Change from Baseline in fasting lipid levels
Safety of VV-14299 and/or VV-14300
Time frame: 52 Weeks
Change from Baseline in the level of antibodies to AAV vector capsid, VV-14300-expressed transgene product, and VV-14299-expressed transgene product by enzyme-linked immunosorbent assay (ELISA)
Humoral immune response to VV-14299 and/or VV-14300
Time frame: 52 Weeks
Change from Baseline in interferon-gamma cellular immune response to AAV1 capsid, VV-14300-expressed transgene product, and VV-14299-expressed transgene product by enzyme-linked immunosorbent spot (ELISpot) assay
Cellular immune response to VV-14299 and/or 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
VV-14299 vector levels in biological samples
Vector shedding of VV-14299 in serum, nasal mucus, urine, semen, feces, saliva (Part 1)
Time frame: 52 Weeks
VV-14299 protein levels in serum
Vector-mediated transgene expression
Time frame: 52 Weeks