Trial · NCT04262479
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| 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) |
| Secondary | Change in Fasting C-peptide | Between baseline and 12 months after the first injection | Change in fasting glucose at 12 months vs baseline (first injection) |
| Secondary | Change in Maximum C-peptide During Mixed Meal Tolerance Test (MMTT) | between baseline 12 months after the first injection | Change in maximum C-peptide value at 12 months vs baseline (first injection) |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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 list from software.
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GET https://conductscience.org/api/trials/v1/NCT04262479/registered