Trial Outcomes & Findings for Injections of Glutamic Acid Decarboxylase (GAD) for LADA Type of Diabetes (NCT NCT04262479)

NCT ID: NCT04262479

Last Updated: 2025-06-08

Results Overview

Injection site skin reactions 1 hour post injection, i.e., erythema, oedema, haematoa, tenderness, pain, itching or other finding.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 14 participants
• Primary outcome timeframe: 1 hour
• Results posted on: 2025-06-08

Participant Flow

Participant milestones

Measure	GAD-vaccination With Vitamin D Suppletion Each study participant will receive 3 injections of 4 µg GAD-alum (Diamyd). The first, second and third injection will be one month apart. Vitamin D (Divisun 2000 IE) will be given from one month before the first injection of GAD-alum until one month after the third injection (120 days in total). recombinant human glutamic acid dehydrogenase (rhGAD65), formulated in aluminium hydrogel: 3 intra-inguinal injections (into the lymph nodes) of GAD-alum one month apart. Supplier Diamyd Medical AB in Stockholm, Sweden Vitamin D: 1 tablet/day, total daily dose of 2000 IE given per os from day -30 through day 90. Supplier Meda, Solna, Sweden
Overall Study STARTED	14
Overall Study COMPLETED	14
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	GAD-vaccination With Vitamin D Suppletion n=14 Participants Each study participant will receive 3 injections of 4 µg GAD-alum (Diamyd). The first, second and third injection will be one month apart. Vitamin D (Divisun 2000 IE) will be given from one month before the first injection of GAD-alum until one month after the third injection (120 days in total). recombinant human glutamic acid dehydrogenase (rhGAD65), formulated in aluminium hydrogel: 3 intra-inguinal injections (into the lymph nodes) of GAD-alum one month apart. Supplier Diamyd Medical AB in Stockholm, Sweden Vitamin D: 1 tablet/day, total daily dose of 2000 IE given per os from day -30 through day 90. Supplier Meda, Solna, Sweden
Age, Categorical <=18 years	0 Participants n=14 Participants
Age, Categorical Between 18 and 65 years	14 Participants n=14 Participants
Age, Categorical >=65 years	0 Participants n=14 Participants
Age, Continuous	46 years n=14 Participants
Sex: Female, Male Female	7 Participants n=14 Participants
Sex: Female, Male Male	7 Participants n=14 Participants
Region of Enrollment Sweden	8 participants n=14 Participants
Region of Enrollment Norway	6 participants n=14 Participants
Time from diagnosis to inclusion, months	4 months n=14 Participants
BMI, kg/m^2	25.1 kg/m^2 n=14 Participants
Fasting C-peptide, nmol/L	0.55 nmol/L n=14 Participants
Fasting glucose, mmol/L	6.7 mmol/L n=14 Participants
HbA1c, mmol/mol	42 mmol/mol n=14 Participants

PRIMARY outcome

Timeframe: 1 hour

Population: All study participants received 3 injections of 4 µg GAD-alum.

Injection site skin reactions 1 hour post injection, i.e., erythema, oedema, haematoa, tenderness, pain, itching or other finding.

Outcome measures

Measure

GAD-vaccination With Vitamin D Suppletion n=14 Participants Each study participant will receive 3 injections of 4 µg GAD-alum (Diamyd). The first, second and third injection will be one month apart. Vitamin D (Divisun 2000 IE) will be given from one month before the first injection of GAD-alum until one month after the third injection (120 days in total). recombinant human glutamic acid dehydrogenase (rhGAD65), formulated in aluminium hydrogel: 3 intra-inguinal injections (into the lymph nodes) of GAD-alum one month apart. Supplier Diamyd Medical AB in Stockholm, Sweden Vitamin D: 1 tablet/day, total daily dose of 2000 IE given per os from day -30 through day 90. Supplier Meda, Solna, Sweden

Injection Site Skin Reactions

4 events

PRIMARY outcome

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

AEs were continuously monitored and registered from the baseline visit (first injection of GAD-alum) to the end of study (12 months after the baseline visit). The total number of AEs registered for all 14 participants during the first 5 months from baseline was summarized when all 14 participants had completed their 5 months study visit (i.e., 5 months after the baseline visit). At the end of study, when all 14 participants had completed their 12 months study visit, the total number of AEs registered for all 14 participants during the 12 months from baseline was summarized.

Outcome measures

Measure

GAD-vaccination With Vitamin D Suppletion n=14 Participants Each study participant will receive 3 injections of 4 µg GAD-alum (Diamyd). The first, second and third injection will be one month apart. Vitamin D (Divisun 2000 IE) will be given from one month before the first injection of GAD-alum until one month after the third injection (120 days in total). recombinant human glutamic acid dehydrogenase (rhGAD65), formulated in aluminium hydrogel: 3 intra-inguinal injections (into the lymph nodes) of GAD-alum one month apart. Supplier Diamyd Medical AB in Stockholm, Sweden Vitamin D: 1 tablet/day, total daily dose of 2000 IE given per os from day -30 through day 90. Supplier Meda, Solna, Sweden

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

28 AEs

PRIMARY outcome

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

AEs were continuously monitored and registered from the baseline visit (first injection of GAD-alum) to the end of study (12 months after the baseline visit/first injection of GAD-alum). The total number of AEs registered for all 14 participants during the first 5 months from baseline was summarized when all 14 participants had completed their 5 months study visit (i.e., 5 months after the baseline visit). At the end of study, when all 14 participants had completed their 12 months study visit, the total number of AEs registered for all 14 participants during the 12 months from baseline was summarized.

Outcome measures

Measure

GAD-vaccination With Vitamin D Suppletion n=14 Participants Each study participant will receive 3 injections of 4 µg GAD-alum (Diamyd). The first, second and third injection will be one month apart. Vitamin D (Divisun 2000 IE) will be given from one month before the first injection of GAD-alum until one month after the third injection (120 days in total). recombinant human glutamic acid dehydrogenase (rhGAD65), formulated in aluminium hydrogel: 3 intra-inguinal injections (into the lymph nodes) of GAD-alum one month apart. Supplier Diamyd Medical AB in Stockholm, Sweden Vitamin D: 1 tablet/day, total daily dose of 2000 IE given per os from day -30 through day 90. Supplier Meda, Solna, Sweden

Occurrence of Adverse Events (AEs) During the Study.

34 AEs

PRIMARY outcome

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

Values present changes in serum GAD65A titers from baseline (first injection of GAD-alum) to 5 months after baseline.

Calculation: Value at 5 months minus value at baseline.

Outcome measures

Measure

GAD-vaccination With Vitamin D Suppletion n=14 Participants Each study participant will receive 3 injections of 4 µg GAD-alum (Diamyd). The first, second and third injection will be one month apart. Vitamin D (Divisun 2000 IE) will be given from one month before the first injection of GAD-alum until one month after the third injection (120 days in total). recombinant human glutamic acid dehydrogenase (rhGAD65), formulated in aluminium hydrogel: 3 intra-inguinal injections (into the lymph nodes) of GAD-alum one month apart. Supplier Diamyd Medical AB in Stockholm, Sweden Vitamin D: 1 tablet/day, total daily dose of 2000 IE given per os from day -30 through day 90. Supplier Meda, Solna, Sweden

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

59218 U/mL Interval -2800.0 to 1006000.0

PRIMARY outcome

Timeframe: Baseline and 12 months after baseline.

Values present changes in serum GAD65A titers from baseline (first injection of GAD-alum) to 12 months after baseline.

Calculation: Value at 12 months minus value at baseline.

Outcome measures

Measure

GAD-vaccination With Vitamin D Suppletion n=14 Participants Each study participant will receive 3 injections of 4 µg GAD-alum (Diamyd). The first, second and third injection will be one month apart. Vitamin D (Divisun 2000 IE) will be given from one month before the first injection of GAD-alum until one month after the third injection (120 days in total). recombinant human glutamic acid dehydrogenase (rhGAD65), formulated in aluminium hydrogel: 3 intra-inguinal injections (into the lymph nodes) of GAD-alum one month apart. Supplier Diamyd Medical AB in Stockholm, Sweden Vitamin D: 1 tablet/day, total daily dose of 2000 IE given per os from day -30 through day 90. Supplier Meda, Solna, Sweden

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

26082 U/mL Interval -631000.0 to 87455.0

PRIMARY outcome

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

Values present changes in serum GAD65A titers from baseline (first injection of GAD-alum) to 12 months after baseline.

Calculation: Value at 12 months minus value at baseline.

Outcome measures

Measure

GAD-vaccination With Vitamin D Suppletion n=14 Participants Each study participant will receive 3 injections of 4 µg GAD-alum (Diamyd). The first, second and third injection will be one month apart. Vitamin D (Divisun 2000 IE) will be given from one month before the first injection of GAD-alum until one month after the third injection (120 days in total). recombinant human glutamic acid dehydrogenase (rhGAD65), formulated in aluminium hydrogel: 3 intra-inguinal injections (into the lymph nodes) of GAD-alum one month apart. Supplier Diamyd Medical AB in Stockholm, Sweden Vitamin D: 1 tablet/day, total daily dose of 2000 IE given per os from day -30 through day 90. Supplier Meda, Solna, Sweden

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

26082 U/mL Interval -631000.0 to 87455.0

SECONDARY outcome

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

Values present changes in serum values of glucagon-stimulated C-peptide from baseline (first injection of GAD-alum) to 5 months after baseline.

Calculation: Value at 5 months minus value at baseline.

Outcome measures

Measure

GAD-vaccination With Vitamin D Suppletion n=14 Participants Each study participant will receive 3 injections of 4 µg GAD-alum (Diamyd). The first, second and third injection will be one month apart. Vitamin D (Divisun 2000 IE) will be given from one month before the first injection of GAD-alum until one month after the third injection (120 days in total). recombinant human glutamic acid dehydrogenase (rhGAD65), formulated in aluminium hydrogel: 3 intra-inguinal injections (into the lymph nodes) of GAD-alum one month apart. Supplier Diamyd Medical AB in Stockholm, Sweden Vitamin D: 1 tablet/day, total daily dose of 2000 IE given per os from day -30 through day 90. Supplier Meda, Solna, Sweden

Insulin Secretion, Change From Baseline to 5 Months After Baseline.

0.00 nmol/L Interval -0.5 to 0.7

SECONDARY outcome

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

Values present changes in serum values of glucagon-stimulated C-peptide from baseline (first injection of GAD-alum) to 12 months after baseline.

Calculation: Value at 12 months minus value at baseline.

Outcome measures

Measure

GAD-vaccination With Vitamin D Suppletion n=14 Participants Each study participant will receive 3 injections of 4 µg GAD-alum (Diamyd). The first, second and third injection will be one month apart. Vitamin D (Divisun 2000 IE) will be given from one month before the first injection of GAD-alum until one month after the third injection (120 days in total). recombinant human glutamic acid dehydrogenase (rhGAD65), formulated in aluminium hydrogel: 3 intra-inguinal injections (into the lymph nodes) of GAD-alum one month apart. Supplier Diamyd Medical AB in Stockholm, Sweden Vitamin D: 1 tablet/day, total daily dose of 2000 IE given per os from day -30 through day 90. Supplier Meda, Solna, Sweden

Insulin Secretion, Change From Baseline to 12 Months After Baseline.

-0.10 nmol/L Interval -0.6 to 0.7

SECONDARY outcome

Timeframe: from baseline to 12 months after the first injection

HbA1c at 12 months vs. baseline (first injection)

Outcome measures

Measure

GAD-vaccination With Vitamin D Suppletion n=14 Participants Each study participant will receive 3 injections of 4 µg GAD-alum (Diamyd). The first, second and third injection will be one month apart. Vitamin D (Divisun 2000 IE) will be given from one month before the first injection of GAD-alum until one month after the third injection (120 days in total). recombinant human glutamic acid dehydrogenase (rhGAD65), formulated in aluminium hydrogel: 3 intra-inguinal injections (into the lymph nodes) of GAD-alum one month apart. Supplier Diamyd Medical AB in Stockholm, Sweden Vitamin D: 1 tablet/day, total daily dose of 2000 IE given per os from day -30 through day 90. Supplier Meda, Solna, Sweden

Change in HbA1c

3.0 mmol/mol Interval -1.0 to 28.0

SECONDARY outcome

Timeframe: From baseline to 12 months after the first injection

Change in fasting glucose at 12 months vs baseline (first injection)

Outcome measures

Measure

GAD-vaccination With Vitamin D Suppletion n=14 Participants Each study participant will receive 3 injections of 4 µg GAD-alum (Diamyd). The first, second and third injection will be one month apart. Vitamin D (Divisun 2000 IE) will be given from one month before the first injection of GAD-alum until one month after the third injection (120 days in total). recombinant human glutamic acid dehydrogenase (rhGAD65), formulated in aluminium hydrogel: 3 intra-inguinal injections (into the lymph nodes) of GAD-alum one month apart. Supplier Diamyd Medical AB in Stockholm, Sweden Vitamin D: 1 tablet/day, total daily dose of 2000 IE given per os from day -30 through day 90. Supplier Meda, Solna, Sweden

Change in Fasting Glucose

-0.05 mmol/L Interval -1.0 to 3.1

SECONDARY outcome

Timeframe: Between baseline and 12 months after the first injection

Change in fasting glucose at 12 months vs baseline (first injection)

Outcome measures

Measure

GAD-vaccination With Vitamin D Suppletion n=14 Participants Each study participant will receive 3 injections of 4 µg GAD-alum (Diamyd). The first, second and third injection will be one month apart. Vitamin D (Divisun 2000 IE) will be given from one month before the first injection of GAD-alum until one month after the third injection (120 days in total). recombinant human glutamic acid dehydrogenase (rhGAD65), formulated in aluminium hydrogel: 3 intra-inguinal injections (into the lymph nodes) of GAD-alum one month apart. Supplier Diamyd Medical AB in Stockholm, Sweden Vitamin D: 1 tablet/day, total daily dose of 2000 IE given per os from day -30 through day 90. Supplier Meda, Solna, Sweden

Change in Fasting C-peptide

-0.03 nmol/L Interval -0.25 to 0.05

SECONDARY outcome

Timeframe: between baseline 12 months after the first injection

Change in maximum C-peptide value at 12 months vs baseline (first injection)

Outcome measures

Measure

GAD-vaccination With Vitamin D Suppletion n=14 Participants Each study participant will receive 3 injections of 4 µg GAD-alum (Diamyd). The first, second and third injection will be one month apart. Vitamin D (Divisun 2000 IE) will be given from one month before the first injection of GAD-alum until one month after the third injection (120 days in total). recombinant human glutamic acid dehydrogenase (rhGAD65), formulated in aluminium hydrogel: 3 intra-inguinal injections (into the lymph nodes) of GAD-alum one month apart. Supplier Diamyd Medical AB in Stockholm, Sweden Vitamin D: 1 tablet/day, total daily dose of 2000 IE given per os from day -30 through day 90. Supplier Meda, Solna, Sweden

Change in Maximum C-peptide During Mixed Meal Tolerance Test (MMTT)

-0.30 nmol/L Interval -0.9 to 0.5

Adverse Events

GAD-vaccination With Vitamin D Suppletion

Serious events: 2 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Measure	GAD-vaccination With Vitamin D Suppletion n=14 participants at risk Each study participant will receive 3 injections of 4 µg GAD-alum (Diamyd). The first, second and third injection will be one month apart. Vitamin D (Divisun 2000 IE) will be given from one month before the first injection of GAD-alum until one month after the third injection (120 days in total). recombinant human glutamic acid dehydrogenase (rhGAD65), formulated in aluminium hydrogel: 3 intra-inguinal injections (into the lymph nodes) of GAD-alum one month apart. Supplier Diamyd Medical AB in Stockholm, Sweden Vitamin D: 1 tablet/day, total daily dose of 2000 IE given per os from day -30 through day 90. Supplier Meda, Solna, Sweden
Cardiac disorders Angina unstable	7.1% 1/14 • Number of events 1 • One year. AEs were continuously monitored and registered from the baseline visit (first injection of GAD-alum) to the end of study (12 months after the baseline visit/first injection of GAD-alum).
Injury, poisoning and procedural complications Muscle rupture	7.1% 1/14 • Number of events 1 • One year. AEs were continuously monitored and registered from the baseline visit (first injection of GAD-alum) to the end of study (12 months after the baseline visit/first injection of GAD-alum).

Other adverse events

Measure	GAD-vaccination With Vitamin D Suppletion n=14 participants at risk Each study participant will receive 3 injections of 4 µg GAD-alum (Diamyd). The first, second and third injection will be one month apart. Vitamin D (Divisun 2000 IE) will be given from one month before the first injection of GAD-alum until one month after the third injection (120 days in total). recombinant human glutamic acid dehydrogenase (rhGAD65), formulated in aluminium hydrogel: 3 intra-inguinal injections (into the lymph nodes) of GAD-alum one month apart. Supplier Diamyd Medical AB in Stockholm, Sweden Vitamin D: 1 tablet/day, total daily dose of 2000 IE given per os from day -30 through day 90. Supplier Meda, Solna, Sweden
Blood and lymphatic system disorders Lymphadenopathy	7.1% 1/14 • Number of events 1 • One year. AEs were continuously monitored and registered from the baseline visit (first injection of GAD-alum) to the end of study (12 months after the baseline visit/first injection of GAD-alum).
Cardiac disorders Tachycardia	7.1% 1/14 • Number of events 1 • One year. AEs were continuously monitored and registered from the baseline visit (first injection of GAD-alum) to the end of study (12 months after the baseline visit/first injection of GAD-alum).
Ear and labyrinth disorders Vertigo or vertigo positional	14.3% 2/14 • Number of events 2 • One year. AEs were continuously monitored and registered from the baseline visit (first injection of GAD-alum) to the end of study (12 months after the baseline visit/first injection of GAD-alum).
Gastrointestinal disorders diarrhoea	14.3% 2/14 • Number of events 2 • One year. AEs were continuously monitored and registered from the baseline visit (first injection of GAD-alum) to the end of study (12 months after the baseline visit/first injection of GAD-alum).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic cystadenoma	7.1% 1/14 • Number of events 1 • One year. AEs were continuously monitored and registered from the baseline visit (first injection of GAD-alum) to the end of study (12 months after the baseline visit/first injection of GAD-alum).
General disorders General disorders and administration site conditions	42.9% 6/14 • Number of events 8 • One year. AEs were continuously monitored and registered from the baseline visit (first injection of GAD-alum) to the end of study (12 months after the baseline visit/first injection of GAD-alum).
Hepatobiliary disorders Biliary colic	7.1% 1/14 • Number of events 1 • One year. AEs were continuously monitored and registered from the baseline visit (first injection of GAD-alum) to the end of study (12 months after the baseline visit/first injection of GAD-alum).
Infections and infestations COVID-19, nasopharyngitis, upper respiratory tract infection	42.9% 6/14 • Number of events 6 • One year. AEs were continuously monitored and registered from the baseline visit (first injection of GAD-alum) to the end of study (12 months after the baseline visit/first injection of GAD-alum).
Injury, poisoning and procedural complications Procedural dizziness	7.1% 1/14 • Number of events 1 • One year. AEs were continuously monitored and registered from the baseline visit (first injection of GAD-alum) to the end of study (12 months after the baseline visit/first injection of GAD-alum).
Injury, poisoning and procedural complications Wrong product administered	7.1% 1/14 • Number of events 1 • One year. AEs were continuously monitored and registered from the baseline visit (first injection of GAD-alum) to the end of study (12 months after the baseline visit/first injection of GAD-alum).
Investigations Blood glucose increased	7.1% 1/14 • Number of events 1 • One year. AEs were continuously monitored and registered from the baseline visit (first injection of GAD-alum) to the end of study (12 months after the baseline visit/first injection of GAD-alum).
Investigations Blood urine present	7.1% 1/14 • Number of events 1 • One year. AEs were continuously monitored and registered from the baseline visit (first injection of GAD-alum) to the end of study (12 months after the baseline visit/first injection of GAD-alum).
Psychiatric disorders Nightmare	7.1% 1/14 • Number of events 3 • One year. AEs were continuously monitored and registered from the baseline visit (first injection of GAD-alum) to the end of study (12 months after the baseline visit/first injection of GAD-alum).
Respiratory, thoracic and mediastinal disorders Nasal congestion and throat irritation	14.3% 2/14 • Number of events 2 • One year. AEs were continuously monitored and registered from the baseline visit (first injection of GAD-alum) to the end of study (12 months after the baseline visit/first injection of GAD-alum).
Social circumstances Menopause	7.1% 1/14 • Number of events 1 • One year. AEs were continuously monitored and registered from the baseline visit (first injection of GAD-alum) to the end of study (12 months after the baseline visit/first injection of GAD-alum).

Additional Information

Ingrid K Hals

NTNU

Phone: +47 73412207

Email: ingrid.hals@ntnu.no

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place