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Type 1 Diabetes MellitusPhase 3DIAGNODE-3NCT05018585

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

A Phase 3 study testing Recombinant human glutamic acid decarboxylase (rhGAD65) formulated in Alhydrogel® and Colecalciferol 2000 IU in people with Type 1 Diabetes Mellitus, run by Diamyd Medical AB at 60 sites in 9 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 12 to 28 years
Conditions the study is for
Type 1 Diabetes Mellitus
What is being tested?
Recombinant human glutamic acid decarboxylase (rhGAD65) formulated in Alhydrogel® and Colecalciferol 2000 IU
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
321 participants
Where
60 sitesin 9 countries
Study dates
19 May 2022to 24 Jun 2026
Phase
Phase 3
Are there results?
None posted in the registry

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 12 to 28 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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.
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  • (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).
  • 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.

Who cannot join

  • 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).
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  • 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).
  • (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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • A history of alcohol or drug abuse or dependence within the past 12 months based on DSM IV criteria.
  • Previous treatment with the active substance recombinant human GAD65.
  • 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.
  • Females who are breastfeeding, pregnant or plan to become pregnant during the trial.
  • 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.
  • An employee or immediate family member of an employee of Diamyd Medical AB.
  • (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.)

Trial locations and contacts

60 sites in 9 countries.

60 sites in 9 countries

United States13 sites

  • Amarillo Medical Specialists

    Amarillo, Texas, 79124

  • University of Colorado Anschutz Medical Campus, Barbara Davis Center for Childhood Diabetes

    Aurora, Colorado, 80045

  • Johns Hopkins University

    Baltimore, Maryland, 21287

  • The Joslin Center

    Boston, Massachusetts, 02215

  • Rocky Mountain Diabetes and Osteoporosis Center

    Idaho Falls, Idaho, 83404

  • University of Iowa Hospital and Clinics

    Iowa City, Iowa, 52242

  • Diabetes Research Institute (DRI)-University of Miami Leonard M. Miller School of Medicine (UMMSM)

    Miami, Florida, 33136

  • Hassenfeld Children&#39;s Hospital at NYU Langone Health, Pediatric Diabetes Center

    New York, New York, 10016

  • Mary and Dick Allen Diabetes Center at Hoag Hospital

    Newport Beach, California, 92663

  • Stanford University School of Medicine Center for Academic Medicine

    Palo Alto, California, 94304

  • Diabetes &amp; Glandular Disease Clinic

    San Antonio, Texas, 78237

  • UCSD/ Rady Children's Hospital

    San Diego, California, 92123

  • Washington University Diabetes Center at Barnes Jewish Hospital

    St Louis, Missouri, 63110

Other trials in United States

Spain12 sites

  • Hospital De Cruces

    Barakaldo, 48903

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035

  • Hospital Clínic de Barcelona

    Barcelona, 08036

  • Hospital de Sant Joan de Déu - Esplugues De Llobregat, Barcelona

    Barcelona, 08950

  • Hospital Universitari de Girona Dr. Josep Trueta

    Girona, 17007

  • Complejo Hospitalario Insular de Gran Canaria

    Las Palmas, 35016

  • Hospital General Universitario Gregorio Marañón

    Madrid, 28007

  • Hospital Universitario Ramón y Cajal

    Madrid, 28034

  • Hospital Universitario La Paz

    Madrid, 28046

  • Hospital Regional Universitario de Málaga

    Málaga, 29010

  • Hospital Universitario Virgen Macarena

    Seville, 41009

  • Hospital General Universitario de Valencia

    Valencia, 46014

Other trials in Spain

Poland8 sites

  • Uniwersytecki Dziecięcy Szpital Kliniczny im. L. Zamenhofa w Białymstoku, Klinika Pediatrii, Endokrynologii, Diabetologii z Pododdziałem Kardiologii

    Bialystok, 15-274

  • Uniwersyteckie Centrum Kliniczne, Klinika Pediatrii, Diabetologii i Endokrynologii

    Gdansk, 80-952

  • SP ZOZ Szpital Uniwersytecki w Krakowie, Oddział Kliniczny Chorób Metabolicznych i Diabetologii

    Krakow, 30-688

  • NZOZ Przychodnia Specjalistyczna Medica

    Lublin, 20-538

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

    Rzeszów, 35-301

  • Instytut Diabetologii Sp. z o.o

    Warsaw, 02-117

  • Panstwowy Instytut Medyczny MSWiA Klinika Chorob Wewnetrznych, Endokrynologii i Diabetologii

    Warsaw, 02-507

  • Instytut Pomnik - Centrum Zdrowia Dziecka (IPCZD) Oddział Diabetologii

    Warsaw, 04-730

Other trials in Poland

Netherlands6 sites

  • CTU Vasculaire Geneeskunde, Locatie Academic Medical Center (AMC)

    Amsterdam, 1105 AZ

  • Albert Schweitzer Ziekenhuis

    Dordrecht, 3318 AT

  • Bethesda Diabetes Research Center te Hoogeveen

    Hoogeveen, 7909 AA

  • Dept. of Nephrology / Dept. of Endocrinology, Leiden University Medical Center (LUMC)

    Leiden, 2333 ZA

  • Vivendia

    Nijmegen, 6532 CL

  • Diabeter Nederland te Rotterdam

    Rotterdam, 3011 TA

Other trials in Netherlands

Hungary5 sites

  • Óbudai Egészségügyi Centrum

    Budapest, 1036

  • Heim Pál Országos Gyermekgyógyászati Intézet, Diabetológia

    Budapest, 1089

  • Észak-Budai Szent János Centrumkórház, Kútvölgyi Kórház, Belgyógyászat

    Budapest, 1125

  • Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi, Oktatókórház, Jósa András Oktatókórház, Gyermekosztály

    Nyíregyháza, 4400

  • Markusovszky Egyetemi Oktatókórház, Diabetológiai Szakrendelés

    Szombathely, 9700

Other trials in Hungary

Czechia4 sites

  • Nemocnice Jihlava, příspěvková organizace

    Jihlava, 586 01

  • Institut klinické a experimentální medicíny

    Prague, 140 21

  • Fakultní nemocnice v Motole

    Prague, 150 06

  • Krajská zdravotní, a.s. - Masarykova nemocnice v Ústí nad Labem, o.z.

    Ústí nad Labem, 400 13

Other trials in Czechia

Estonia4 sites

  • Liina Viitas OÜ

    Pärnu, 80018

  • North-Estonian Regional Hospital

    Tallinn, 13419

  • Tartu University Hospital

    Tartu, 50406

  • Tartu University Hospital, Children's Clinic

    Tartu, 51014

Other trials in Estonia

Germany4 sites

  • Diabetespraxis Dr. Braun

    Berlin, 131 87

  • Diabetologische Schwerpunktpraxis Dres. Klaus

    Dortmund, 441 37

  • DZDM - Diabeteszentrum Duisburg Mitte

    Duisburg, 470 51

  • Justus-Liebig-Universität Gießen

    Giessen, 353 92

Other trials in Germany

Sweden4 sites

  • H.K.H Kronprinsessan Victorias Barn-och Ungdomssjukhus, Universitetssjukhuset i Linköping

    Linköping, Östergötland County, 581 85

  • Skånes universitetssjukhus

    Malmö, Skåne County, 20502

  • Akademiskt Specialistcentrum, Centrum for Diabetes

    Stockholm, Stockholm County, 102 35

  • Barn-och Ungdomscentrum Västerbotten, Norrlands Universitetssjukhus

    Umeå, Västerbotten County, 901 85

Other trials in Sweden

About this study

Official title: A Phase III, Randomized, Double-blind, Placebo-controlled, Multicenter Trial to Evaluate the Efficacy and Safety of Diamyd® to Preserve Endogenous Beta Cell Function in Adolescents and Adults With Recently Diagnosed Type 1 Diabetes, Carrying the Genetic HLA DR3-DQ2 Haplotype

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.

Read the detailed description

The study is a 2-arm, randomized, double-blind, placebo-controlled, multicenter, clinical trial. Patients will have the HLA genotyping performed at the first Screening visit (Visit 1A). If the results indicate the patient is carrying the HLA DR3-DQ2 haplotype, then the patient will attend the second Screening visit (Visit 1B) to perform the remaining screening procedures. Eligible patients will receive injections of Diamyd (also known as retogatein) or placebo into an inguinal lymph gland at three occasions, with one month intervals along with oral Vitamin D supplementation. All patients will continue to receive intensive insulin treatment from their personal physicians during the whole study period. Patients will be followed in a blinded manner for a total of 24 months.

Being tested
Recombinant human glutamic acid decarboxylase (rhGAD65) formulated in Alhydrogel®, Colecalciferol 2000 IU, Placebo
Keywords
Diabetes Mellitus, residual beta cell function, HLA DR3-DQ2, Diabetes Mellitus, Type 1, Autoimmune Diseases, Metabolic Disease, Autoimmune Diabetes, Vitamin D, Immune System Diseases, Insulin Dependent Diabetes, rhGAD65, GAD65, GAD-alum, residual c-peptide, T1D, recent-onset T1D, Type 1 Diabetes, HLA, Diamyd, Diabetes
Medical subject headings
Diabetes Mellitus, Type 1, Diabetes Mellitus, 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.

  • Recombinant human glutamic acid decarboxylase (rhGAD65) formulated in Alhydrogel®Biological

    Also called Diamyd

    Recombinant human glutamic acid decarboxylase (rhGAD65) formulated in Alhydrogel®

  • Colecalciferol 2000 IUDietary supplement

    Also called Divisun 2000 IU

    Colecalciferol (vitamin D3) 2000 IU (equivalent to 50 microgram vitamin D3).

  • PlaceboBiological

    Placebo for Diamyd, Alhydrogel® only

Study groups in NCT05018585
Study groupRoleWhat they receive
DiamydExperimentalPatients will be assigned to receive i) three (3) intralymphatic injections with 4µg Diamyd (rhGAD65) on Days 0, 30, and 60 and; ii) oral vitamin D 2000 IU/daily for 4 months (from Day -30 through Day 90)
Receives: Biological: Recombinant human glutamic acid decarboxylase (rhGAD65) formulated in Alhydrogel®; Dietary Supplement: Colecalciferol 2000 IU
PlaceboPlacebo comparatorPatients will be assigned to receive i) three (3) intralymphatic injections of Placebo on Days 0, 30, and 60 and; ii) oral vitamin D 2000 IU/daily for 4 months (from Day -30 through Day 90)
Receives: Dietary Supplement: Colecalciferol 2000 IU; Biological: Placebo

What is being measured

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

  1. Beta cell function

    Change from baseline to Month 15 in C-peptide area under the curve (AUC) mean 0-120 min during a 2-hour mixed meal tolerance test (MMTT)

    Measured: Baseline to 15 months

  2. Glycemic control

    Change from baseline to Month 15 in hemoglobin A1c (HbA1c).

    Measured: Baseline to 15 months

Secondary outcomes (10)

  1. 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) [evaluated from continuous glucose monitoring (CGM) data] between baseline and Month 15.

    Measured: Baseline and 15 months

  2. Proportion of patients with a stimulated 90 min C-peptide level above 0.2 nmol/L (0.6 ng/ml) at Month 15

    Proportion of patients with a stimulated 90 min C-peptide level above 0.2 nmol/L (0.6 ng/ml) at Month 15.

    Measured: Baseline to Month 15

  3. Proportion of patients with HbA1c <7 % (53 mmol/mol)

    Proportion of patients with HbA1c <7 % (53 mmol/mol) at Month 15.

    Measured: Baseline to Month 15

  4. Change in exogenous insulin requirements

    Change from baseline to Month 15 in exogenous insulin requirements based on total number of units of insulin per kilogram body weight per day.

    Measured: Baseline to Month 15

  5. Change in hypoglycemic episodes per day

    Change in number of hypoglycemic <3.0 mmol/L (<54 mg/dL) episodes per day [evaluated from CGM data] between baseline and Month 15.

    Measured: Baseline to Month 15

  6. Area Under the Curve Change from Baseline in HbA1c

    Area Under the Curve for Change from Baseline to Month 15 in HbA1c.

    Measured: Baseline to Month 15

  7. Severe hypoglycemic episodes per patient

    Number of episodes per patient of severe hypoglycemia between baseline and Month 15.

    Measured: Baseline and 15 months

  8. Diabetic ketoacidosis episodes per patient

    Number of episodes per patient of diabetic ketoacidosis (DKA) between baseline and Month 15

    Measured: Baseline and 15 months

  9. Beta cell function Month 24

    Change from baseline to Month 24 in C-peptide area under the curve (AUC)mean 0-120 min during a 2-hour mixed meal tolerance test (MMTT)

    Measured: Baseline to Month 24

  10. Glycemic control Month 24

    Change from baseline to Month 24 in hemoglobin A1c (HbA1c).

    Measured: Baseline to Month 24

Timeline

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

  1. First posted24 Aug 2021
  2. Study start19 May 2022
  3. Primary completion24 Jun 2026
  4. Study completion24 Jun 2026

Why it stopped: Stopped for futility.

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
The study is a 2-arm, randomized, double-blind, placebo-controlled, multicenter, clinical trial.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
321 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05018585
Sponsor's protocol ID
DIAGNODE-3 (D/P3/21/7)
Other IDs
2024-513304-33-00
Acronym
DIAGNODE-3
Status last verified
Aug 2026
First submitted
18 Aug 2021
Last updated
26 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Ludvigsson J, Eriksson L, Nowak C, Teixeira PF, Widman M, Lindqvist A, Casas R, Lind M, Hannelius U. Phase III, randomised, double-blind, placebo-controlled, multicentre trial to evaluate the efficacy and safety of rhGAD65 to preserve endogenous beta cell function in adolescents and adults with recently diagnosed type 1 diabetes, carrying the genetic HLA DR3-DQ2 haplotype: the DIAGNODE-3 study protocol. BMJ Open. 2022 Oct 31;12(10):e061776. doi: 10.1136/bmjopen-2022-061776.

    PubMed 36316084

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Recombinant human glutamic acid decarboxylase (rhGAD65) formulated in Alhydrogel® and Colecalciferol 2000 IU in people with Type 1 Diabetes Mellitus, run by Diamyd Medical AB at 60 sites in 9 countries.

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 29 inclusion and 41 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: stopped early, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 60 sites in United States, Spain, Poland, Netherlands, Hungary and 4 more countries. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

The study was stopped early (reason given: Stopped for futility.). Results are not available in the source record.

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?

Beta cell function (time frame: Baseline to 15 months). The study lists 2 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 NCT05018585, which also lists 1 linked publication.

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 26 Aug 2026; AzTrials last refreshed its copy on 2 Nov 2026.

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