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

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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	30-70 years
Treatment	recombinant human glutamic acid dehydrogenase (rhGAD65), formulated in aluminium hydrogel, Vitamin D
Clinical Study Identifier	NCT04262479
Sponsor	Norwegian University of Science and Technology
Last Modified on	19 February 2024

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