Insulin, Intranasal vs Placebo, Intranasal: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
Measures 6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note | Source |
|---|---|---|---|---|---|---|
| Risk in group 1 | 0.2 | 0.0567 | 0.51 | wilson | ClinicalTrials.gov | |
| Risk in group 2 | 0.182 | 0.0514 | 0.477 | wilson | ClinicalTrials.gov | |
| Risk difference, group 1 minus group 2 | 0.0182 | -0.31 | 0.354 | newcombe hybrid score | ClinicalTrials.gov | |
| Risk ratio, group 1 over group 2 | 1.1 | 0.189 | 6.41 | log | ClinicalTrials.gov | |
| Odds ratio, group 1 over group 2 | 1.13 | 0.127 | 9.94 | log | ClinicalTrials.gov | |
| Number needed to harm, for one more participant with a serious adverse event on Insulin, Intranasal than on Placebo, Intranasal | 55 | from the risk difference interval | the interval includes no difference | ClinicalTrials.gov |
Groups 2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code | Source |
|---|---|---|---|---|---|---|
| Group 1 | Insulin, Intranasal | Regular insulin, 20 IU intranasal twice a day for 24 weeks; 0.2 mL per dose~Insulin, intranasal: Regular insulin administered by specialized, non-commercial intranasal drug delivery device | 2 | 10 | EG000 | ClinicalTrials.gov |
| Group 2 | Placebo, Intranasal | Saline solution (placebo), intranasal twice a day for 24 weeks; 0.2 mL per dose~Placebo, intranasal: Saline solution administered by specialized, non-commercial intranasal drug delivery device | 2 | 11 | EG001 | ClinicalTrials.gov |
Harm 2
| Field | Value | Source |
|---|---|---|
| What it counts | Total, serious adverse events | ClinicalTrials.gov |
| Time frame | AEs were reported monthly over the 24-week period that each participant was on study or when taken off study if he/she did not complete the trial. Participants who completed the trial were followed up to 4 weeks after taking the last dose of the investigational product. Participants who stopped the intervention early remained on study for continued follow-up, to the extent possible, through study visits, telephone communication, and medical record review for intent-to-treat analysis. | ClinicalTrials.gov |
Trial 8
| Field | Value | Source |
|---|---|---|
| Title | Intranasal Insulin for the Treatment of HAND | ClinicalTrials.gov |
| NCT number | NCT03081117 | ClinicalTrials.gov |
| Phases | PHASE1, PHASE2 | ClinicalTrials.gov |
| Conditions | HIV Dementia, HIV-Associated Cognitive Motor Complex | ClinicalTrials.gov |
| Interventions | Insulin, intranasal, Placebo, intranasal | ClinicalTrials.gov |
| Lead sponsor | Johns Hopkins University | ClinicalTrials.gov |
| Results first posted | 2021-07-07 | ClinicalTrials.gov |
| Results on ClinicalTrials.gov | https://clinicaltrials.gov/study/NCT03081117?tab=results | ClinicalTrials.gov |
Source 4
| Field | Value | Source |
|---|---|---|
| Release | trial-comparisons-2026-03-23-0.1.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57 | ClinicalTrials.gov |
| AACT copy | 2026-03-23 | ClinicalTrials.gov |
| Tables read | outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet | ClinicalTrials.gov |
Release trial-comparisons-2026-03-23-0.1.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.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.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.