Evaluating Diamyd® for preventing Type 1 diabetes in at-risk youth

DiaPrecise, a Phase II Open Label Study to Evaluate the Safety and Feasibility of Intralymphatic Administration of Diamyd® in Individuals At Risk for Type 1 Diabetes Carrying the HLA DR3-DQ2 Haplotype

This study is testing if giving a new treatment called Diamyd® through injections can help prevent Type 1 diabetes in kids and teens who are at risk.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 16 (estimated)
• Ages: 8 Years to 18 Years
• Sex: All
• Sponsor: Diamyd Medical AB (Industry-sponsored)
• Locations: 1 site (Malmö)
• Trial ID: NCT05683990 on ClinicalTrials.gov

What this trial studies

This is a Phase II, open-label, randomized clinical trial assessing the safety and feasibility of intralymphatic administration of Diamyd® in individuals aged 8 to under 18 years who are at risk for Type 1 diabetes and carry the HLA DR3-DQ2 haplotype. Participants will receive either 2 or 3 injections of Diamyd® into an inguinal lymph node and will be monitored for 12 months post-enrollment. The study aims to determine if this treatment can effectively prevent the onset of Type 1 diabetes in those with multiple islet autoantibodies.

Who should consider this trial

Good fit: Ideal candidates are children and adolescents aged 8 to under 18 years with the HLA DR3-DQ2 haplotype and multiple islet autoantibodies.

Not a fit: Patients who have already been diagnosed with Type 1 diabetes or those with elevated fasting glucose levels will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce the risk of developing Type 1 diabetes in genetically predisposed individuals.

How similar studies have performed: Other studies have explored similar immunotherapy approaches for Type 1 diabetes, but this specific method of intralymphatic administration of Diamyd® is relatively novel.

Eligibility criteria

Inclusion Criteria:

1. Written informed consent/assent from the individual and the individual's parents or caretaker(s) according to local regulations.
2. Males and females aged ≥8 and \<18 years old at the time of Screening.
3. Possess the HLA DR3-DQ2 haplotype.
4. Seropositive for GADA and at least one additional T1D-associated autoantibody (IA-2A, ZnT8A or IAA).

Exclusion Criteria:

1. Diagnosis of T1D (stage 3 T1D, according to the American Diabetes Association \[ADA\] classification).
2. 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.
3. Treatment with any anti-diabetic medication, including the use of external insulin.
4. Participation in any other clinical trial testing pharmaceutical treatments.
5. 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.
6. History of hyperparathyroidism, hypercalcemia and/or nephrolithiasis, unless appropriately treated, or any other contraindication to use of Vitamin D.
7. History of epilepsy, serious head trauma or cerebrovascular accident, or clinical features of continuous motor unit activity in proximal muscles
8. Any clinically significant history of an acute reaction to a vaccine or its constituents (e.g., Alhydrogel) or lidocaine (local anesthetic)
9. Any acute or chronic skin infection or condition that would preclude intralymphatic injection.
10. Treatment with any (live or inactive) vaccine, including influenza vaccine and Coronavirus Disease 2019 (COVID-19) vaccine, within 4 weeks prior to planned first dose of study drug; or planned treatment with any vaccine up to 4 weeks after the last injection with study drug.
11. Ongoing diagnosed post-COVID19 syndrome.
12. Known diagnosis of human immunodeficiency virus (HIV), hepatitis B or hepatitis C infection. Individuals with previous hepatitis C infection that is now cured may be eligible.
13. Any clinically significant concomitant medical condition, including but not limited to other autoimmune diseases, cardiovascular, gastrointestinal, hematological, immune, renal including a history of renal transplantation or neurological that in the opinion of the investigator would interfere with trial participation or procedures. Celiac disease with adequate diet as well as stable autoimmune thyroiditis will be permitted.
14. Any clinically significant abnormal findings detected during Screening that might jeopardize the individual's safety or ability to complete the trial.
15. Females who are lactating or pregnant (for females who have started menstruating the possibility of pregnancy must be excluded by urine βHCG onsite prior to the study drug administration).
16. Males or females not willing to use adequate contraception, if sexually active, until 90 days after the last Diamyd administration. Adequate contraception is as follows:

For females of childbearing potential (FOCBP)

1. oral (except low-dose gestagen (lynestrenol and norestisteron)), injectable, or implanted hormonal contraceptives
2. intrauterine device
3. intrauterine system (for example, progestin-releasing coil)
4. refraining from heterosexual intercourse if that is the preferred and usual lifestyle of the subject.

For sexually active males

1. condom
2. Abstinence from heterosexual intercourse if that is the preferred and usual lifestyle of the subject.

Where this trial is running

Malmö

• Lund University/CRC, Skåne University Hospital, — Malmö, Sweden (Recruiting)

Study contacts

• Study coordinator: Chief Operating Officer

Conditions Diabetes Mellitus, Type 1; Autoimmune Diseases; Prevention; HLA DR3-DQ2; Metabolic Disease; Autoimmune Diabetes; Vitamin D; Immune System Diseases