CompletedPhase 2

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

Norway, Sweden14 participantsStarted 2020-03-02

Plain-language 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.

Who can participate

Age range

30 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Exclusion criteria

. Females must agree to avoid pregnancy, and must have a negative urine pregnancy test.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Injection Site Skin Reactions

Timeframe: 1 hour

Occurrence of Adverse Events (AEs) During 5 Months From Baseline.

Timeframe: From baseline (first injection of GAD-alum) to 5 months after baseline.

Occurrence of Adverse Events (AEs) During the Study.

Timeframe: From baseline (first injection of GAD-alum) to 12 months after baseline.

Serum GAD65A Titers, Change From Baseline at 5 Months After Baseline.

Timeframe: Baseline (first injection of GAD-alum) and 5 months after baseline.

Serum GAD65A Titers, Change From Baseline at 12 Months After Baseline.

Timeframe: Baseline and 12 months after baseline.

Serum GAD65A Titers, Change From Baseline at 12 Months After Baseline.

Timeframe: Baseline (first injection of GAD-alum) and 12 months after baseline.

Trial details

NCT IDNCT04262479

SponsorNorwegian University of Science and Technology

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-05-05

Results submitted2024-09-09

View on ClinicalTrials.gov More Latent Autoimmune Diabetes in Adults trials

Who can participate

Age range

30 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Exclusion criteria

. Females must agree to avoid pregnancy, and must have a negative urine pregnancy test.

What they're measuring

Injection Site Skin Reactions

Timeframe: 1 hour

Occurrence of Adverse Events (AEs) During 5 Months From Baseline.

Timeframe: From baseline (first injection of GAD-alum) to 5 months after baseline.

Occurrence of Adverse Events (AEs) During the Study.

Timeframe: From baseline (first injection of GAD-alum) to 12 months after baseline.

Serum GAD65A Titers, Change From Baseline at 5 Months After Baseline.

Timeframe: Baseline (first injection of GAD-alum) and 5 months after baseline.

Serum GAD65A Titers, Change From Baseline at 12 Months After Baseline.

Timeframe: Baseline and 12 months after baseline.

Serum GAD65A Titers, Change From Baseline at 12 Months After Baseline.

Timeframe: Baseline (first injection of GAD-alum) and 12 months after baseline.