Trial · NCT04262479
Injections of Glutamic Acid Decarboxylase (GAD) for LADA Type of Diabetes
NCT04262479, Phase 2, Completed, Norwegian University of Science and Technology; results first posted 2025-06-08
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Injections of Glutamic Acid Decarboxylase (GAD) for LADA Type of Diabetes. Trials, record NCT04262479. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04262479
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Injections of Glutamic Acid Decarboxylase (GAD) for LADA Type of Diabetes
- NCT number
- NCT04262479
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 14 participants, actual
- Lead sponsor
- Norwegian University of Science and Technology
- Conditions
- Latent Autoimmune Diabetes in Adults
- Interventions
- recombinant human glutamic acid dehydrogenase (rhGAD65), formulated in aluminium hydrogel, Vitamin D
- First posted
- 2020-02-10
- Last updated
- 2025-06-08
- Other registries' IDs
- eudract:2019-002692-34
- Results first posted
- 2025-06-08
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Injection Site Skin Reactions | 1 hour | Injection site skin reactions 1 hour post injection, i.e., erythema, oedema, haematoa, tenderness, pain, itching or other finding. |
| Primary | Occurrence of Adverse Events (AEs) During 5 Months From Baseline. | 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. |
| Primary | Occurrence of Adverse Events (AEs) During the Study. | 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. |
| Primary | Serum GAD65A Titers, Change From Baseline at 5 Months After Baseline. | 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. |
| Primary | Serum GAD65A Titers, Change From Baseline at 12 Months After Baseline. | 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. |
| Primary | Serum GAD65A Titers, Change From Baseline at 12 Months After Baseline. | 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. |
| Secondary | Insulin Secretion, Change From Baseline to 5 Months After Baseline. | 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. |
| Secondary | Insulin Secretion, Change From Baseline to 12 Months After Baseline. | 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. |
| Secondary | Change in HbA1c | from baseline to 12 months after the first injection | HbA1c at 12 months vs. baseline (first injection) |
| Secondary | Change in Fasting Glucose | From baseline to 12 months after the first injection | Change in fasting glucose at 12 months vs baseline (first injection) |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Injection Site Skin Reactions | 1 hour | All study participants received 3 injections of 4 µg GAD-alum. | events | NUMBER |
| PRIMARY | Occurrence of Adverse Events (AEs) During 5 Months From Baseline. | From baseline (first injection of GAD-alum) to 5 months after baseline. | AEs | NUMBER | |
| PRIMARY | Occurrence of Adverse Events (AEs) During the Study. | From baseline (first injection of GAD-alum) to 12 months after baseline. | AEs | NUMBER | |
| PRIMARY | Serum GAD65A Titers, Change From Baseline at 5 Months After Baseline. | Baseline (first injection of GAD-alum) and 5 months after baseline. | U/mL | MEDIAN | |
| PRIMARY | Serum GAD65A Titers, Change From Baseline at 12 Months After Baseline. | Baseline and 12 months after baseline. | U/mL | MEDIAN | |
| SECONDARY | Insulin Secretion, Change From Baseline to 5 Months After Baseline. | Baseline (first injection of GAD-alum) and 5 months after baseline. | nmol/L | MEDIAN | |
| SECONDARY | Insulin Secretion, Change From Baseline to 12 Months After Baseline. | Baseline (first injection of GAD-alum) and 12 months after baseline. | nmol/L | MEDIAN | |
| SECONDARY | Change in HbA1c | from baseline to 12 months after the first injection | mmol/mol | MEDIAN | |
| SECONDARY | Change in Fasting Glucose | From baseline to 12 months after the first injection | mmol/L | MEDIAN | |
| SECONDARY | Change in Fasting C-peptide | Between baseline and 12 months after the first injection | nmol/L | MEDIAN |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Injection Site Skin Reactions | GAD-vaccination With Vitamin D Suppletion | 4 | events | ||
| Occurrence of Adverse Events (AEs) During 5 Months From Baseline. | GAD-vaccination With Vitamin D Suppletion | 28 | AEs | ||
| Occurrence of Adverse Events (AEs) During the Study. | GAD-vaccination With Vitamin D Suppletion | 34 | AEs | ||
| Serum GAD65A Titers, Change From Baseline at 5 Months After Baseline. | GAD-vaccination With Vitamin D Suppletion | 59218 | Full Range -2800 to 1006000 | U/mL | |
| Serum GAD65A Titers, Change From Baseline at 12 Months After Baseline. | GAD-vaccination With Vitamin D Suppletion | 26082 | Full Range -631000 to 87455 | U/mL | |
| Insulin Secretion, Change From Baseline to 5 Months After Baseline. | GAD-vaccination With Vitamin D Suppletion | 0.00 | Full Range -0.50 to 0.70 | nmol/L | |
| Insulin Secretion, Change From Baseline to 12 Months After Baseline. | GAD-vaccination With Vitamin D Suppletion | -0.10 | Full Range -0.60 to 0.70 | nmol/L | |
| Change in HbA1c | GAD-vaccination With Vitamin D Suppletion | 3.0 | Full Range -1.0 to 28.0 | mmol/mol | |
| Change in Fasting Glucose | GAD-vaccination With Vitamin D Suppletion | -0.05 | Full Range -1.00 to 3.10 | mmol/L | |
| Change in Fasting C-peptide | GAD-vaccination With Vitamin D Suppletion | -0.03 | Full Range -0.25 to 0.05 | nmol/L |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | GAD-vaccination With Vitamin D Suppletion | 14 | |
| Overall Study | COMPLETED | GAD-vaccination With Vitamin D Suppletion | 14 | |
| Overall Study | NOT COMPLETED | GAD-vaccination With Vitamin D Suppletion | 0 |
Source ClinicalTrials.gov
Adverse events17
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Lymphadenopathy | Blood and lymphatic system disorders | GAD-vaccination With Vitamin D Suppletion | 1 | 14 | 1 |
| other | Tachycardia | Cardiac disorders | GAD-vaccination With Vitamin D Suppletion | 1 | 14 | 1 |
| other | Vertigo or vertigo positional | Ear and labyrinth disorders | GAD-vaccination With Vitamin D Suppletion | 2 | 14 | 2 |
| other | diarrhoea | Gastrointestinal disorders | GAD-vaccination With Vitamin D Suppletion | 2 | 14 | 2 |
| other | Pancreatic cystadenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | GAD-vaccination With Vitamin D Suppletion | 1 | 14 | 1 |
| other | General disorders and administration site conditions | General disorders | GAD-vaccination With Vitamin D Suppletion | 6 | 14 | 8 |
| other | Biliary colic | Hepatobiliary disorders | GAD-vaccination With Vitamin D Suppletion | 1 | 14 | 1 |
| other | COVID-19, nasopharyngitis, upper respiratory tract infection | Infections and infestations | GAD-vaccination With Vitamin D Suppletion | 6 | 14 | 6 |
| other | Procedural dizziness | Injury, poisoning and procedural complications | GAD-vaccination With Vitamin D Suppletion | 1 | 14 | 1 |
| other | Wrong product administered | Injury, poisoning and procedural complications | GAD-vaccination With Vitamin D Suppletion | 1 | 14 | 1 |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | GAD-vaccination With Vitamin D Suppletion | 0 | 14 |
| Total, other adverse events | GAD-vaccination With Vitamin D Suppletion | 12 | 14 |
| Total, serious adverse events | GAD-vaccination With Vitamin D Suppletion | 2 | 14 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 31148332 | BACKGROUND |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04262479
GET https://conductscience.org/api/trials/v1/NCT04262479/registered