AzTrials
AzTrials

Diabetes Mellitus, Type 1Phase 2NCT05683990

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

A Phase 2 study testing Diamyd in people with Diabetes Mellitus, Type 1 and Autoimmune Diseases, run by Diamyd Medical AB at 1 site in Sweden.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 8 to 18 years
What is being tested?
Diamyd
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5 participants
Where
1 siteSweden
Study dates
9 Jul 2024to 31 Mar 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 8 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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).

Who cannot join

  • 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.
Show all 24Show fewer
  • 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).
  • 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)
  • oral (except low-dose gestagen (lynestrenol and norestisteron)), injectable, or implanted hormonal contraceptives
  • intrauterine device
  • intrauterine system (for example, progestin-releasing coil)
  • refraining from heterosexual intercourse if that is the preferred and usual lifestyle of the subject.
  • For sexually active males
  • condom
  • Abstinence from heterosexual intercourse if that is the preferred and usual lifestyle of the subject.

Trial locations and contacts

1 site in 1 country.

Sweden1 site

  • Lund University/CRC, Skåne University Hospital,

    Malmö

Other trials in Sweden

About this study

Official title: 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

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.

Read the detailed description

The trial is a 2-arm, randomized, open label clinical trial in individuals aged 8 - <18 years with HLA DR3-DQ2 and multiple islet autoantibodies (Stage 1 or Stage 2) at increased risk for T1D. At baseline eligible individuals at risk of T1D will be randomized 1:1 into 2 or 3 injections of Diamyd® also known as retogatein administered into an inguinal lymph node. Subjects will be followed for a total of 12 months post-enrollment.

Being tested
Diamyd
Keywords
HLA DR3-DQ2, Metabolic Disease, Autoimmune Diabetes, Vitamin D, Immune System Diseases, GAD65, Residual c-peptide, T1D, Type 1 Diabetes, Diamyd, retogatein
Medical subject headings
Diabetes Mellitus, Type 1, Autoimmune Diseases, Metabolic Diseases, Immune System Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DiamydDrug

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

Study groups in NCT05683990
Study groupRoleWhat they receive
Arm 1Experimental2 injections of Diamyd
Receives: Drug: Diamyd
Arm 2Experimental3 injections of Diamyd
Receives: Drug: Diamyd

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Occurrence of AEs (including Injection site reactions) and SAEs

    Measured: From screening to 12 months.

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

    Measured: 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

    Measured: From screening to 12 months.

Secondary outcomes (11)

  1. Stage progression

    Number of individuals progressing from stage 1 to stage 2 and from stage 2 to stage 3.

    Measured: From screening to 12 months.

  2. T1D diagnosis

    Time to T1D diagnosis.

    Measured: From screening to 12 months.

  3. Time to stage progression

    Time from stage 1 to stage 2 and time from stage 2 to stage 3.

    Measured: From screening to 12 months.

  4. OGTT stimulated C-peptide

    Change in C-peptide /insulin /glucose (Area Under the Curve [AUC]mean 0-120 min) during a 2-hour Oral Glucose Tolerance Test (OGTT) from screening to 12 months.

    Measured: From screening to 12 months.

  5. Change in Hemoglobin A1c (HbA1c)

    Change in Hemoglobin A1c (HbA1c) from baseline to 12 months.

    Measured: From baseline to 12 months.

  6. Change in time in glycemic target range

    Change in time in glycemic target range 3.9 to 10 mmol/L (70 to 180 mg/dL) and 3.9 to 7.8 mmol/L (70 to 140 mg/dL) evaluated from continuous glucose monitoring (CGM) data from screening to 12 months.

    Measured: From screening to 12 months.

  7. Change in time in range > 13.9 mmol/L

    Change in time in range > 13.9 mmol/L (> 250 mg/dL) evaluated from CGM data from screening to 12 months.

    Measured: From screening to 12 months.

  8. Change in time in range > 10 mmol/L

    Change in time in range > 10 mmol/L (> 180 mg/dL) evaluated from CGM data from screening to 12 months.

    Measured: From screening to 12 months.

  9. Change in time in range > 7.8 mmol/L

    Change in time in range > 7.8 mmol/L (> 140 mg/dL) evaluated from CGM data from screening to 12 months.

    Measured: From screening to 12 months.

  10. Change in glycemic variation

    Change in glycemic variation (Coefficient of variation [CV], SD) evaluated from CGM data from screening to 12 months.

    Measured: From screening to 12 months.

  11. Variables that indicate effects on the immune system

    Variables that indicate effects on the immune system such as the concentration of serum autoantibodies.

    Measured: From baseline to 12 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jan 2023
  2. Study start9 Jul 2024
  3. Primary completion31 Mar 2028 (estimated)
  4. Study completion31 Mar 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
5 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05683990
Sponsor's protocol ID
DiaPrecise (D/P2/22/8)
Status last verified
Apr 2026
First submitted
20 Dec 2022
Last updated
20 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Diamyd in people with Diabetes Mellitus, Type 1 and Autoimmune Diseases, run by Diamyd Medical AB at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 20 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Occurrence of AEs (including Injection site reactions) and SAEs (time frame: From screening to 12 months.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05683990.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in