Study to Evaluate the Safety and Feasibility of Diamyd® in Individuals at Risk for Type 1 Diabetes (NCT05683990) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Study to Evaluate the Safety and Feasibility of Diamyd® in Individuals at Risk for Type 1 Diabetes
Sweden5 participantsStarted 2024-07-09
Plain-language summary
A 2-arm randomized Phase II Open Label Study to evaluate the safety and feasibility of intralymphatic administration of Diamyd® (Diamyd) also known as retogatein in individuals at risk of Type 1 diabetes carrying the HLA DR3-DQ2 haplotype.
Who can participate
Age range8 Years – 18 Years
SexALL
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Inclusion criteria
âś“. Written informed consent/assent from the individual and the individual's parents or caretaker(s) according to local regulations.
✓. Males and females aged ≥8 and \<18 years old at the time of Screening.
âś“. Possess the HLA DR3-DQ2 haplotype.
âś“. Seropositive for GADA and at least one additional T1D-associated autoantibody (IA-2A, ZnT8A or IAA).
Exclusion criteria
âś•. Diagnosis of T1D (stage 3 T1D, according to the American Diabetes Association \[ADA\] classification).
âś•. Fasting glucose \> 7 mmol/L (126 mg/dl), 2-hour-OGTT plasma glucose \> 11.1 mmol/L (200 mg/dL) or HbA1c \> 6.5% (48 mmol/mol) at the screening Visit.
âś•. Treatment with any anti-diabetic medication, including the use of external insulin.
âś•. Participation in any other clinical trial testing pharmaceutical treatments.
✕. Recent (past 12 months) or current treatment with immunosuppressant therapy, including chronic use of glucocorticoid therapy. Inhaled, topical, and intranasal steroid use is acceptable. Short courses (e.g., ≤5 days) of oral or intra-articular injections of steroids will be permitted on trial.
âś•. History of hyperparathyroidism, hypercalcemia and/or nephrolithiasis, unless appropriately treated, or any other contraindication to use of Vitamin D.
âś•. History of epilepsy, serious head trauma or cerebrovascular accident, or clinical features of continuous motor unit activity in proximal muscles
What they're measuring
1
Occurrence of AEs (including Injection site reactions) and SAEs
Timeframe: From screening to 12 months.
2
Number of Clinically Significant Abnormal Results from Physical examinations, including neurological and Vital Signs assessments
Timeframe: From screening to 12 months.
3
Number of Clinically Significant Abnormal Results From Laboratory measurements, including hematology, clinical chemistry, metabolic status parameters (fasting C-peptide, HbA1c, fasting glucose) and urine analysis