Injections of Glutamic Acid Decarboxylase (GAD) for LADA Type of Diabetes (NCT04262479) | Clinical Trial Compass
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 range30 Years – 70 Years
SexALL
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.
✕. 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
✕
What they're measuring
1
Injection Site Skin Reactions
Timeframe: 1 hour
2
Occurrence of Adverse Events (AEs) During 5 Months From Baseline.
Timeframe: From baseline (first injection of GAD-alum) to 5 months after baseline.
3
Occurrence of Adverse Events (AEs) During the Study.
Timeframe: From baseline (first injection of GAD-alum) to 12 months after baseline.
4
Serum GAD65A Titers, Change From Baseline at 5 Months After Baseline.
Timeframe: Baseline (first injection of GAD-alum) and 5 months after baseline.
5
Serum GAD65A Titers, Change From Baseline at 12 Months After Baseline.
Timeframe: Baseline and 12 months after baseline.
6
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