New shot aims to keep insulin flowing in type 1 diabetes

NCT ID NCT05018585

Disease control Sponsor: Diamyd Medical AB Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Aug 27, 2026 · Updated 2 times

Summary

This study tests a drug called Diamyd in people aged 12 to 29 who were recently diagnosed with type 1 diabetes and have a specific genetic type (HLA DR3-DQ2). The goal is to see if Diamyd can help the body keep making its own insulin, which could improve blood sugar control and reduce the need for injected insulin. Participants receive three injections into a lymph node along with vitamin D, and their insulin production is measured over 15 months.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

321 people

The number who actually took part.

Started

May 2022

Finished

Jun 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

12 to 28 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: Patients are eligible to be included in this study only if all of the following criteria apply: 1. 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. 2. Males and females aged ≥12 and \<29 years old at the time of Screening (V1A). 3. Diagnosed with T1D (according to the American Diabetes Association \[ADA\] classification) ≤6 months at the time of Screening (V1A). 4. Possess the HLA DR3-DQ2 haplotype (all patients will be tested; prior genetic testing results will not be accepted). 5. 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. 6. Possess detectable circulating GAD65 antibodies (lowest level of detection defined by the method used by the central laboratory). 7. Possess HbA1c levels between 35 to 80 mmol/mol (5.4 to 9.5%) on at least one occasion prior to randomization. 8. 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. 9. 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). 9\. ii. Male patients must agree to remain abstinent from heterosexual sex during treatment and for 90 days after treatment or, if sexually active, to use two effective methods of birth control (e.g., male uses a condom and female uses contraception) during and for 90 days after treatment. Acceptable male contraception is as follows: * Condom (male). * Abstinence from heterosexual intercourse. * Vasectomy. The agreement to remain abstinent or use two effective methods of birth control will be clearly defined in the informed consent; the patient or legally authorized representatives (e.g., parents, caregivers, or legal guardians) must sign this specific section. Exclusion Criteria: Patients are not eligible to be included in this study if any of the following criteria apply: 1. Participation in any other trial aimed to influence beta cell function from time of diagnosis of T1D. 2. 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. 3. History of maturity-onset diabetes of the young (MODY). 4. Pancreatic surgery, chronic pancreatitis, or other pancreatic disorders that could result in decreased beta cell capacity (e.g., pancreatogenous diabetes). 5. Occurrence of DKA or severe hypoglycemia requiring hospitalization in the period of 90 days prior to Randomization (Visit 2). 6. Signs or symptoms suggesting very poorly controlled diabetes e.g., ongoing weight loss, polyuria or polydipsia. 7. Hematologic condition that would make HbA1c uninterpretable including: 1. Hemoglobinopathy, with the exception of sickle cell trait or thalassemia minor; or chronic or recurrent hemolysis. 2. 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. 3. Significant iron deficiency anemia. 4. Heart malformations or vaso-occlusive crisis (VOC) leading to increased turnover of erythrocytes. 8. (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 9. 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. 10. (US ONLY) History of hyperparathyroidism, hypercalcemia and/or nephrolithiasis, unless appropriately treated, or any other contraindication to use of Vitamin D. 11. Any clinically significant history of an acute reaction to a vaccine or its constituents (e.g., Alhydrogel). 12. 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. 13. Any acute or chronic skin infection or condition that would preclude intralymphatic injection. 14. 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. 15. 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. 16. Known or suspected acute infection, including COVID-19 or influenza, at the time of Randomization or within 4 weeks prior to Randomization. 17. A history of epilepsy, head trauma or cerebrovascular accident, or clinical features of continuous motor unit activity in proximal muscles. 18. 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. 19. 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). 20. (US ONLY) Significant cardiovascular disease (including inadequately controlled hypertension \[resting blood pressure \>140/90 mmHg despite treatment\], history of myocardial infarction, angina, use of anti-anginal medicines \[e.g., nitroglycerin\], or abnormal cardiac stress test. 21. History of significant hepatic disease or Screening alanine aminotransferase (ALT) \>2.5 x upper limit of normal (ULN) or aspartate aminotransferase (AST) 3 x ULN and/or total bilirubin \>2 x ULN. Patients with documented Gilbert syndrome and total bilirubin level ≥2 x ULN due to unconjugated hyperbilirubinemia, without other hepatic impairment, are permitted. 22. Estimated glomerular filtration rate (eGFR) calculated by Chronic Kidney Disease Epidemiology Collaboration (CKD-Epi) for those \>18 years, or by the Schwartz equation for those 12 to 18 years old, \<60 mL/min per 1.73 m or rapidly progressing renal disease. 23. Patients diagnosed with hypothyroidism or hyperthyroidism must be on stable treatment for at least 3 months prior to Randomization (with normal free thyroxine \[T4\] levels if hypothyroid). (US ONLY) Patients diagnosed with hypothyroidism or hyperthyroidism must be on stable treatment for at least 3 months prior to Randomization (with normal free thyroxine \[T4\] levels if hypothyroid). A thyroid-stimulating hormone (TSH) level \> 1.5 times the ULN at Screening (V1B) is an exclusion criterion. 24. Any clinically significant abnormal findings during Screening, and any other medical condition(s) or laboratory findings that, in the opinion of the investigator, might jeopardize the patient's safety or ability to complete the trial. (US ONLY) Any clinically significant abnormal findings during Screening, and any other medical condition(s) or laboratory findings that, in the opinion of the investigator, might jeopardize the patient's safety or ability to complete the trial. This includes anticipated major surgery during the duration of the trial, which could interfere with participation in the trial. 25. History of malignancy not in remission within the last 5 years other than adequately treated basal cell or squamous cell skin cancer or cervical carcinoma in situ. 26. Patients with any mental condition rendering him/her unable to understand the nature, scope and possible consequences of the trial, and/or evidence of poor compliance with medical instructions at Screening or showing non-compliance during the Run-In Period. 27. A history of alcohol or drug abuse or dependence within the past 12 months based on DSM IV criteria. 28. Previous treatment with the active substance recombinant human GAD65. 29. Participation in a clinical trial involving administration of an investigational drug in the past 3 months or 5 half-lives (whichever is longer) prior to first dosing of trial drug or during the trial. 30. Females who are breastfeeding, pregnant or plan to become pregnant during the trial. 31. Patients who in the opinion of the investigator will not be able to follow instructions and/or follow the trial procedures or patients that are unwilling or unable to comply with the provisions of this protocol. 32. An employee or immediate family member of an employee of Diamyd Medical AB. 33. (US ONLY)For subjects aged 18 years and older, a body mass index (BMI) ≥30 kg/m2 or ≤18.5 kg/m2; for subjects aged under 18 years BMI ≥95th percentile or ≤5th percentile for age and sex according to the US Centre for Disease Control and Prevention at V1B. (For subjects aged 18 years and older with a BMI ≥25 to ≤30 kg/m2, and for subjects aged under 18 years with a BMI ≥85th to ≤95th percentile, re-confirmation of Type 1 Diabetes diagnoses by an external, independent endocrinologist is required prior to randomization.)

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Conditions

The condition(s) this trial relates to.

autoimmune disease diabetes mellitus immune system disorder metabolic disease type 1 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Type 1 diabetes mellitus

Contacts and locations

Locations

Akademiskt Specialistcentrum, Centrum for Diabetes

Stockholm, Stockholm County, 102 35, Sweden
Albert Schweitzer Ziekenhuis

Dordrecht, 3318 AT, Netherlands
Amarillo Medical Specialists

Amarillo, Texas, 79124, United States
Barn-och Ungdomscentrum Västerbotten, Norrlands Universitetssjukhus

Umeå, Västerbotten County, 901 85, Sweden
Bethesda Diabetes Research Center te Hoogeveen

Hoogeveen, 7909 AA, Netherlands
CTU Vasculaire Geneeskunde, Locatie Academic Medical Center (AMC)

Amsterdam, 1105 AZ, Netherlands
Complejo Hospitalario Insular de Gran Canaria

Las Palmas, 35016, Spain
DZDM - Diabeteszentrum Duisburg Mitte

Duisburg, 470 51, Germany
Dept. of Nephrology / Dept. of Endocrinology, Leiden University Medical Center (LUMC)

Leiden, 2333 ZA, Netherlands
Diabeter Nederland te Rotterdam

Rotterdam, 3011 TA, Netherlands
Diabetes & Glandular Disease Clinic

San Antonio, Texas, 78237, United States
Diabetes Research Institute (DRI)-University of Miami Leonard M. Miller School of Medicine (UMMSM)

Miami, Florida, 33136, United States
Diabetespraxis Dr. Braun

Berlin, 131 87, Germany
Diabetologische Schwerpunktpraxis Dres. Klaus

Dortmund, 441 37, Germany
Fakultní nemocnice v Motole

Prague, 150 06, Czechia
H.K.H Kronprinsessan Victorias Barn-och Ungdomssjukhus, Universitetssjukhuset i Linköping

Linköping, Östergötland County, 581 85, Sweden
Hassenfeld Children's Hospital at NYU Langone Health, Pediatric Diabetes Center

New York, New York, 10016, United States
Heim Pál Országos Gyermekgyógyászati Intézet, Diabetológia

Budapest, 1089, Hungary
Hospital Clínic de Barcelona

Barcelona, 08036, Spain
Hospital De Cruces

Barakaldo, 48903, Spain
Hospital General Universitario Gregorio Marañón

Madrid, 28007, Spain
Hospital General Universitario de Valencia

Valencia, 46014, Spain
Hospital Regional Universitario de Málaga

Málaga, 29010, Spain
Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain
Hospital Universitari de Girona Dr. Josep Trueta

Girona, 17007, Spain
Hospital Universitario La Paz

Madrid, 28046, Spain
Hospital Universitario Ramón y Cajal

Madrid, 28034, Spain
Hospital Universitario Virgen Macarena

Seville, 41009, Spain
Hospital de Sant Joan de Déu - Esplugues De Llobregat, Barcelona

Barcelona, 08950, Spain
Institut klinické a experimentální medicíny

Prague, 140 21, Czechia
Instytut Diabetologii Sp. z o.o

Warsaw, 02-117, Poland
Instytut Pomnik - Centrum Zdrowia Dziecka (IPCZD) Oddział Diabetologii

Warsaw, 04-730, Poland
Johns Hopkins University

Baltimore, Maryland, 21287, United States
Justus-Liebig-Universität Gießen

Giessen, 353 92, Germany
Kliniczny Szpital Wojewódzki nr 2 im. Św. Jadwigi Królowej w Rzeszowie, II Klinika Pediatrii, Endokrynologii i Diabetologii Dziecięcej

Rzeszów, 35-301, Poland
Krajská zdravotní, a.s. - Masarykova nemocnice v Ústí nad Labem, o.z.

Ústí nad Labem, 400 13, Czechia
Liina Viitas OÜ

Pärnu, 80018, Estonia
Markusovszky Egyetemi Oktatókórház, Diabetológiai Szakrendelés

Szombathely, 9700, Hungary
Mary and Dick Allen Diabetes Center at Hoag Hospital

Newport Beach, California, 92663, United States
NZOZ Przychodnia Specjalistyczna Medica

Lublin, 20-538, Poland
Nemocnice Jihlava, příspěvková organizace

Jihlava, 586 01, Czechia
North-Estonian Regional Hospital

Tallinn, 13419, Estonia
Panstwowy Instytut Medyczny MSWiA Klinika Chorob Wewnetrznych, Endokrynologii i Diabetologii

Warsaw, 02-507, Poland
Rocky Mountain Diabetes and Osteoporosis Center

Idaho Falls, Idaho, 83404, United States
SP ZOZ Szpital Uniwersytecki w Krakowie, Oddział Kliniczny Chorób Metabolicznych i Diabetologii

Krakow, 30-688, Poland
Skånes universitetssjukhus

Malmö, Skåne County, 20502, Sweden
Stanford University School of Medicine Center for Academic Medicine

Palo Alto, California, 94304, United States
Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi, Oktatókórház, Jósa András Oktatókórház, Gyermekosztály

Nyíregyháza, 4400, Hungary
Tartu University Hospital

Tartu, 50406, Estonia
Tartu University Hospital, Children's Clinic

Tartu, 51014, Estonia
The Joslin Center

Boston, Massachusetts, 02215, United States
UCSD/ Rady Children's Hospital

San Diego, California, 92123, United States
University of Colorado Anschutz Medical Campus, Barbara Davis Center for Childhood Diabetes

Aurora, Colorado, 80045, United States
University of Iowa Hospital and Clinics

Iowa City, Iowa, 52242, United States
Uniwersytecki Dziecięcy Szpital Kliniczny im. L. Zamenhofa w Białymstoku, Klinika Pediatrii, Endokrynologii, Diabetologii z Pododdziałem Kardiologii

Bialystok, 15-274, Poland
Uniwersyteckie Centrum Kliniczne, Klinika Pediatrii, Diabetologii i Endokrynologii

Gdansk, 80-952, Poland
Vivendia

Nijmegen, 6532 CL, Netherlands
Washington University Diabetes Center at Barnes Jewish Hospital

St Louis, Missouri, 63110, United States
Észak-Budai Szent János Centrumkórház, Kútvölgyi Kórház, Belgyógyászat

Budapest, 1125, Hungary
Óbudai Egészségügyi Centrum

Budapest, 1036, Hungary

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