Injections of Glutamic Acid Decarboxylase (GAD) for LADA Type of Diabetes

  • STATUS
    Recruiting
  • participants needed
    15
  • sponsor
    Norwegian University of Science and Technology
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Updated on 19 February 2024
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diabetes
vitamins
vitamin d
vitamin d supplementation
metformin
ergocalciferol

Summary

This study will evaluate the effects of 3 intra-nodal injections of GAD-alum (Diamyd), together with oral vitamin D supplementation. Safety and feasibility of the treatment will be evaluated and also effects on the immune system and on the preservation of endogenous insulin production.

Details
Condition Diabetes Mellitus
Age 30years - 70years
Treatment recombinant human glutamic acid dehydrogenase (rhGAD65), formulated in aluminium hydrogel, Vitamin D
Clinical Study IdentifierNCT04262479
SponsorNorwegian University of Science and Technology
Last Modified on19 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

Signed informed consent by the patient
Diagnosis of LADA within the last 12 months before inclusion. LADA should be defined by the criteria of age 30 years at the onset of diabetes, anti-GAD positivity and no clinical need for insulin treatment during the first 6 months after the diagnosis of diabetes
Fasting C-peptid levels 0.3 nmol/l
High GADA titers (>190 U/ml)
Patients must be insulin independent at baseline by clinical judgement and C-peptide criteria

Exclusion Criteria

Females must agree to avoid pregnancy, and must have a negative urine pregnancy test
Patients of childbearing potential must agree to use adequate contraception
until one (1) year after the last administration of GAD-alum. Adequate
contraception is as follows
For females of childbearing potential
oral (except lowdose gestagen (lynestrenol and norestisteron)), injectable, or implanted hormonal contraceptives
combined (estrogen and progestogen containing)
oral, intravaginal or transdermal progesterone hormonal contraception associated with inhibition of ovulation
intrauterine device
intrauterine hormone-releasing system (for example, progestinreleasing coil)
bilateral tubal occlusion
vasectomized male (with appropriate post vasectomy documentation of the absence of sperm in the ejaculate)
male partner using condom
abstinence from heterosexual intercourse
For males of childbearing potential
condom (male)
abstinence from heterosexual intercourse
Exclusion Criteria
Current or previous treatment with immunosuppressant therapy (topical or inhaled steroids are accepted)
Continuous treatment with anti-inflammatory drug (sporadic treatment e.g. because of headache or in connection with fever a few days will be accepted)
Systemic treatment with glucocorticoids
Treatment with any vaccine, including influenza vaccine, within 4 months prior to planned first study drug dose or planned treatment with any vaccine up to 4 months after the last injection with study drug
Antidiabetic medication (metformin excepted)
Significantly abnormal hematology results at screening (i.e. anemia with hemoglobin < 12 g/L)
A history of epilepsy, head trauma or cerebrovascular accident, or clinical features of continuous motor unit activity in proximal muscles
Clinically significant history of acute reaction to vaccines in the past
Renal disease (as defined by serum creatinine >150 mol/l)
Serious cardiovascular events (myocardial infarction, stroke) within the last year preceding recruitment
Participation in other clinical trials with a new chemical entity within the previous 3 months
A history of alcohol or drug abuse
Known HIV or hepatitis
Presence of associated serious disease or condition, including active skin infections that preclude intralymphatic injection, which in the opinion of the investigator makes the patient non-eligible for the study
Other serious chronic disease as judged by investigator
Females who are lactating, are pregnant or intend to become pregnant
Inability or unwillingness to comply with the provisions of this protocol
Deemed by the investigator not being able to follow instructions and/or follow the study protocol
Treatment with vitamin D, marketed or not, or unwilling to abstain from such medication during the trial
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