Phase 2 N=14 Treatment

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

Latent Autoimmune Diabetes in Adults

Bottom Line

View on ClinicalTrials.gov: NCT04262479 ↗

Enrolled (actual)

Serious AEs

14.3%

Results posted

Jun 2025

Primary outcome: Primary: Injection Site Skin Reactions — 4 events

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: recombinant human glutamic acid dehydrogenase (rhGAD65), formulated in aluminium hydrogel (Drug); Vitamin D (Drug)
Age: Adult, Older Adult · 30+ yrs
Sex: All
Sponsor: Norwegian University of Science and Technology
Primary completion: May 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Injection Site Skin Reactions	4	—
PRIMARY Occurrence of Adverse Events (AEs) During 5 Months From Baseline.	28	—
PRIMARY Occurrence of Adverse Events (AEs) During the Study.	34	—
PRIMARY Serum GAD65A Titers, Change From Baseline at 5 Months After Baseline.	59218	<0.001 sig
PRIMARY Serum GAD65A Titers, Change From Baseline at 12 Months After Baseline.	26082	—
PRIMARY Serum GAD65A Titers, Change From Baseline at 12 Months After Baseline.	26082	—
SECONDARY Insulin Secretion, Change From Baseline to 5 Months After Baseline.	0.00	<0.61
SECONDARY Insulin Secretion, Change From Baseline to 12 Months After Baseline.	-0.10	<0.30
SECONDARY Change in HbA1c	3.0	<0.002 sig
SECONDARY Change in Fasting Glucose	-0.05	<0.72
SECONDARY Change in Fasting C-peptide	-0.03	<0.03 sig
SECONDARY Change in Maximum C-peptide During Mixed Meal Tolerance Test (MMTT)	-0.30	<0.044 sig

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.

Eligibility Criteria

Inclusion Criteria

Signed informed consent by the patient.
Diagnosis of LADA and diabetes debut within the last 18 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 permanent insulin treatment during the first 3 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
Antidiabetic medication in the form of metformin is acceptable for inclusion as well as medications not mentioned under 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 low-dose 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, progestin-releasing 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 1 month prior to planned first study drug dose or planned treatment with any vaccine up to 1 month after the last injection with study drug
Antidiabetic medication (metformin excepted)
Significantly abnormal hematology results at screening (i.e. anemia with hemoglobin 150 µmol/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 any other supplementation of with vitamin D, marketed or not, or unwilling to abstain from such medication during the trial 120 days daily intake of Divisun (non-investigational medicinal product)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04262479). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.