Study to Evaluate the Safety and Feasibility of Diamyd® in Individuals at Risk for Type 1 Diabetes

NCT05683990 | Active Not Recruiting Phase 2 DMC

• 1 other identifier: DiaPrecise (D/P2/22/8)
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetes Mellitus, Type 1; Autoimmune Diseases; Prevention

Keywords

HLA DR3-DQ2; Metabolic Disease; Autoimmune Diabetes; Vitamin D; Immune System Diseases; GAD65; Residual c-peptide; T1D; Type 1 Diabetes; Diamyd; retogatein

Outcome Measures

Primary Outcomes (3)

• Occurrence of AEs (including Injection site reactions) and SAEs

  From screening to 12 months.

• Number of Clinically Significant Abnormal Results from Physical examinations, including neurological and Vital Signs assessments

  From screening to 12 months.

• 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

  From screening to 12 months.

Secondary Outcomes (11)

• Stage progression

  From screening to 12 months.

• T1D diagnosis

  From screening to 12 months.

• Time to stage progression

  From screening to 12 months.

• OGTT stimulated C-peptide

  From screening to 12 months.

• Change in Hemoglobin A1c (HbA1c)

  From baseline to 12 months.

Study Arms (2)

Arm 1

EXPERIMENTAL

2 injections of Diamyd

Drug: Diamyd

Arm 2

EXPERIMENTAL

3 injections of Diamyd

Drug: Diamyd

Interventions

Diamyd DRUG

4 μg (0.1 mL) of Diamyd administered 1 month apart.

Arm 1; Arm 2

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.
• Possess the HLA DR3-DQ2 haplotype.
• Seropositive for GADA and at least one additional T1D-associated autoantibody (IA-2A, ZnT8A or IAA).

You may not qualify if:

• Diagnosis of T1D (stage 3 T1D, according to the American Diabetes Association \[ADA\] classification).
• 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.
• Treatment with any anti-diabetic medication, including the use of external insulin.
• 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.
• History of hyperparathyroidism, hypercalcemia and/or nephrolithiasis, unless appropriately treated, or any other contraindication to use of Vitamin D.
• History of epilepsy, serious head trauma or cerebrovascular accident, or clinical features of continuous motor unit activity in proximal muscles
• Any clinically significant history of an acute reaction to a vaccine or its constituents (e.g., Alhydrogel) or lidocaine (local anesthetic)
• Any acute or chronic skin infection or condition that would preclude intralymphatic injection.
• 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.
• Ongoing diagnosed post-COVID19 syndrome.
• 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.
• 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.
• Any clinically significant abnormal findings detected during Screening that might jeopardize the individual's safety or ability to complete the trial.
• 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).

Sponsors & Collaborators

• Diamyd Medical AB: lead

Study Sites (1)

Lund University/CRC, Skåne University Hospital,

Malmo, Sweden

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Autoimmune Diseases; Metabolic Diseases; Immune System Diseases

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2022
• First Posted: January 13, 2023
• Study Start: July 9, 2024
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): March 31, 2028
• Last Updated: April 20, 2026

Record last verified: 2026-04

Locations

SE (1)