A Phase III Study to Investigate if the Study Drug Diamyd Can Preserve Insulin Production and Improve Glycemic Control in Patients Newly Diagnosed With Type 1 Diabetes

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: Type 1 Diabetes Mellitus

In brief

The objective of DIAGNODE-3 is to evaluate the efficacy and safety of three intranodal injections of 4 μg of Diamyd also known as retogatein compared to placebo, along with oral Vitamin D supplementation, to preserve endogenous beta cell function and influence glycemic parameters in adolescent and adults recently diagnosed with T1D carrying the HLA DR3-DQ2 haplotype.

Key facts

Study ID: NCT05018585
Run by: Diamyd Medical AB
People needed: 321
Starts: 2022-05-19
Expected to finish: 2027-12-01
Last updated by the study team: 2026-04-15

Who can join

Age: 12 and older, up to 28. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Patients are eligible to be included in this study only if all of the following criteria apply:
Must be capable of providing written, signed, and dated informed consent; and for patients who are minors, age-appropriate assent (performed according to local regulations) and parent/caregiver consent.
Males and females aged ≥12 and <29 years old at the time of Screening (V1A).
Diagnosed with T1D (according to the American Diabetes Association [ADA] classification) ≤6 months at the time of Screening (V1A).
Possess the HLA DR3-DQ2 haplotype (all patients will be tested; prior genetic testing results will not be accepted).
Fasting C-peptide ≥0.12 nmol/L (≥0.36 ng/mL) on at least one occasion prior to randomization.
(US ONLY): Fasting C-peptide ≥0.12 - ≤1.5 nmol/L (≥0.36 - ≤4.5 ng/mL) on at least one occasion prior to randomization.
Possess detectable circulating GAD65 antibodies (lowest level of detection defined by the method used by the central laboratory).
Possess HbA1c levels between 35 to 80 mmol/mol (5.4 to 9.5%) on at least one occasion prior to randomization.
Be on a stable basal insulin dose for one month prior to inclusion with limited fluctuation of daily basal insulin requirement based on investigator's assessment. For example, if the average basal insulin dose/kg/24h over a 7-day period compared to the previous 7-day period does not vary more than approximately 20% and/or if the daily basal insulin dose does not vary more than 0.1 U/kg/24h, the dose can be considered stable. Individuals that are diagnosed with T1D according to the ADA classification but are not taking insulin are eligible to participate.
i. Females of childbearing potential (FOCBP) must agree to avoid pregnancy and have a negative pregnancy test performed at the required study visits.
FOCBP must agree to use highly effective contraception, during treatment and, until 90 days after the last administration of study medication. Birth control methods, which may be considered as highly effective (e.g., a failure rate of less than 1% per year when used consistently and correctly) include:
Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation:
Oral.
Intravaginal.
Transdermal.
Progestogen-only hormonal contraception associated with inhibition of ovulation:
Oral.
Injectable.
Implantable.
Intrauterine device.
Intrauterine hormone-releasing system.
Bilateral tubal occlusion.
Vasectomized partner (vasectomized partner is a highly effective birth control method provided that partner is the sole sexual partner of the FOCBP trial patient and that the vasectomized partner has received medical assessment of the surgical success).
Sexual abstinence (sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study drugs. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient).

You may not qualify if…

Patients are not eligible to be included in this study if any of the following criteria apply:
Participation in any other trial aimed to influence beta cell function from time of diagnosis of T1D.
Treatment with any oral or non-insulin injectable anti-diabetic medication or other substance used with the intention to preserve beta cell function (e.g., Verapamil, GABA etc.) within 3 months prior to Randomization.
History of maturity-onset diabetes of the young (MODY).
Pancreatic surgery, chronic pancreatitis, or other pancreatic disorders that could result in decreased beta cell capacity (e.g., pancreatogenous diabetes).
Occurrence of DKA or severe hypoglycemia requiring hospitalization in the period of 90 days prior to Randomization (Visit 2).
Signs or symptoms suggesting very poorly controlled diabetes e.g., ongoing weight loss, polyuria or polydipsia.
Hematologic condition that would make HbA1c uninterpretable including:
Hemoglobinopathy, with the exception of sickle cell trait or thalassemia minor; or chronic or recurrent hemolysis.
Donation of blood or blood products to a blood bank, blood transfusion or participation in a clinical study requiring withdrawal of >400 mL of blood during the 8 weeks prior to the Screening visit.
Significant iron deficiency anemia.
Heart malformations or vaso-occlusive crisis (VOC) leading to increased turnover of erythrocytes.
(US ONLY) Clinically significant abnormal hematology results at the time of Screening, specifically any of the following: white blood cells: < 3.5 x 10\^9/L or >15 x 10\^9/L; platelets: <124 x 10\^9/ L hemoglobin: <10.5 g/dL
Treatment with marketed or over-the-counter Vitamin D at the time of Screening (V1C) and unwilling to abstain from such medication during the 120 days when the patient will be supplemented with the trial-provided Vitamin D. A patient currently taking Vitamin D at the time of Screening (V1C) must be willing to switch to the trial-provided Vitamin D treatment and to administer it per the trial requirements.
(US ONLY) History of hyperparathyroidism, hypercalcemia and/or nephrolithiasis, unless appropriately treated, or any other contraindication to use of Vitamin D.
Any clinically significant history of an acute reaction to a vaccine or its constituents (e.g., Alhydrogel).
Treatment with any (live or inactive) vaccine, including influenza vaccine and Coronavirus Disease 2019 (COVID-19) vaccine, within 4 weeks prior to planned first trial dose of trial drug; or planned treatment with any vaccine up to 4 weeks after the last injection with trial drug.
Any acute or chronic skin infection or condition that would preclude intralymphatic injection.
Recent (past 12 months) or current treatment with Teplizumab (TZIELD®) or with immunosuppressant therapy, including chronic use of systemic glucocorticoid therapy. Inhaled, topical, and intranasal steroid use is acceptable. Short courses (e.g., ≤5 days) of oral, intra-articular injections or injections of steroids will be permitted during the trial.
Continuous/chronic treatment with prescribed or over-the-counter anti-inflammatory therapies. Short-term use (e.g., <7 days) is permissible, for example to treat a headache or in connection with a fever.
Known or suspected acute infection, including COVID-19 or influenza, at the time of Randomization or within 4 weeks prior to Randomization.
A history of epilepsy, head trauma or cerebrovascular accident, or clinical features of continuous motor unit activity in proximal muscles.
Known diagnosis of human immunodeficiency virus (HIV), hepatitis B or hepatitis C infection. Patients 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, neurological (including Batten disease), significant diabetes complication, any underlying conditions or receiving treatments that could affect red blood cell turnover or other diseases that in the opinion of the investigator would interfere with trial participation or procedures. Celiac disease or elevated transglutaminase antibody titers is not a reason for exclusion.
(US ONLY) Any clinically significant concomitant medical condition, including but not limited to other autoimmune or immune deficiency diseases (e.g., sarcoidosis, rheumatoid arthritis, moderate-to-severe psoriasis, inflammatory bowel disease, and other autoimmune conditions that may require treatment with TNF-alpha inhibitors or other biologics), gastrointestinal, hematological, or renal diseases including a history of any organ transplant (including renal transplantation and islet transplantation), neurological disease (including Batten disease); significant diabetes complication; a history of adrenal insufficiency; any underlying conditions or receiving treatments that could affect red blood cell turnover or other diseases that interfere with trial participation or procedures. Celiac disease or elevated transglutaminase antibody titers is not a reason for exclusion, as well as autoimmune thyroid disease under certain conditions (see Exclusion Criterion #23).

Where it is running

Stanford University School of Medicine Center for Academic Medicine — Palo Alto, California, United States
UCSD/ Rady Children's Hospital — San Diego, California, United States
University of Colorado Anschutz Medical Campus, Barbara Davis Center for Childhood Diabetes — Aurora, Colorado, United States
Diabetes Research Institute (DRI)-University of Miami Leonard M. Miller School of Medicine (UMMSM) — Miami, Florida, United States
Rocky Mountain Diabetes and Osteoporosis Center — Idaho Falls, Idaho, United States
University of Iowa Hospital and Clinics — Iowa City, Iowa, United States
Johns Hopkins University — Baltimore, Maryland, United States
The Joslin Center — Boston, Massachusetts, United States
Washington University Diabetes Center at Barnes Jewish Hospital — St Louis, Missouri, United States
Hassenfeld Children's Hospital at NYU Langone Health, Pediatric Diabetes Center — New York, New York, United States
Amarillo Medical Specialists — Amarillo, Texas, United States
Diabetes & Glandular Disease Clinic — San Antonio, Texas, United States
Nemocnice Jihlava, příspěvková organizace — Jihlava, Czechia
Institut klinické a experimentální medicíny — Prague, Czechia
Fakultní nemocnice v Motole — Prague, Czechia
Krajská zdravotní, a.s. - Masarykova nemocnice v Ústí nad Labem, o.z. — Ústí nad Labem, Czechia
Liina Viitas OÜ — Pärnu, Estonia
North-Estonian Regional Hospital — Tallinn, Estonia
Tartu University Hospital — Tartu, Estonia
Tartu University Hospital, Children's Clinic — Tartu, Estonia
Diabetespraxis Dr. Braun — Berlin, Germany
Diabetologische Schwerpunktpraxis Dres. Klaus — Dortmund, Germany
DZDM - Diabeteszentrum Duisburg Mitte — Duisburg, Germany
Justus-Liebig-Universität Gießen — Giessen, Germany
Mary and Dick Allen Diabetes Center at Hoag Hospital — Newport Beach, California, United States

Full record on ClinicalTrials.gov

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