Diamyd Administered Into Lymph Nodes in Individuals Recently Diagnosed With Type 1 Diabetes, Carrying the HLA DR3-DQ2 Haplotype (DIAGNODE-3)

  • STATUS
    Recruiting
  • End date
    Dec 31, 2025
  • participants needed
    330
  • sponsor
    Diamyd Medical AB
Updated on 27 July 2022
diabetes
insulin
fasting
vitamin d
treatment regimen
hemoglobin a1c
c-peptide

Summary

The objective of DIAGNODE-3 is to evaluate the efficacy and safety of three intranodal injections of 4 μg of Diamyd 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.

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/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.

Details
Condition Diabetes Mellitus, Type 1, Diabetes Mellitus, Autoimmune Diseases, Immune System Disease, Diabetes, Juvenile Diabetes, Endocrine System Diseases, Insulin Dependent Diabetes Mellitus 1, Glucose Metabolism Disorders, Metabolic Disease, Autoimmune Diabetes
Treatment Recombinant human glutamic acid decarboxylase (rhGAD65) formulated in Alhydrogel®, Colecalciferol 2000 IU, Placebo for recombinant human glutamic acid decarboxylase (rhGAD65) formulated in Alhydrogel®
Clinical Study IdentifierNCT05018585
SponsorDiamyd Medical AB
Last Modified on27 July 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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
Diagnosed with T1D (according to the American Diabetes Association [ADA]
classification) ≤6 months at the time of Screening
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 (maximum two
tests on different days during the Screening period)
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 (maximum one additional test within one month from Visit 1B)
Be on a stable insulin dose or insulin dosing regimen for one month prior to inclusion
with limited fluctuation of daily insulin requirement based on investigator's
assessment. For example, if the average insulin dose/kg/24h over a 7-day period
compared to the previous 7-day period does not vary more than approximately 15% and/or
if the daily 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)
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
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 within
months prior to Screening
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)
History of DKA or severe hypoglycemia requiring hospitalization within one month
before Screening, or severe episodes of hypoglycemia requiring third party
assistance within one month before Screening
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
Treatment with marketed or over-the-counter Vitamin D at the time of Screening
and unwilling to abstain from such medication during the 120 days when the
patient will be supplemented with the study-provided Vitamin D. A patient
currently taking Vitamin D at the time of Screening must be willing to switch to
the study-provided Vitamin D treatment and to administer it per the study
requirements
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 study dose of study drug; or planned treatment with any vaccine up to 4
weeks after the last injection with study drug
Any acute or chronic skin infection or condition that would preclude
intralymphatic injection
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
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 Screening or within 2 weeks prior to Screening. After confirmed recent
COVID-19 infection, a negative polymerase chain reaction test will be required
before 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 with adequate
diet before diagnosis or discovered by increased autoantibodies at Screening will
be permitted
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 old, and by the Schwartz
equation for those 12 to 18 years old, <90 mL/min per 1.73 m or rapidly
progressing renal disease
Patients with hypothyroidism or hyperthyroidism must be on stable treatment for
at least 3 months prior to Screening (with normal free thyroxine [T4] levels if
hypothyroid)
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
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
Current or previous participation in a trial of Diamyd
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 study 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 study 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
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