Comparison · NCT04618744-sae
ORMD-0801 (Insulin) Capsule 8 mg BD vs Placebo: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. ORMD-0801 (Insulin) Capsule 8 mg BD vs Placebo: serious adverse events. Trial comparisons, record NCT04618744-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04618744-sae
On this page
Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.0476 | 0.00846 | 0.227 | wilson | |
| Risk in group 2 | 0.0909 | 0.0162 | 0.377 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0433 | -0.332 | 0.151 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.524 | 0.0361 | 7.59 | log | |
| Odds ratio, group 1 over group 2 | 0.5 | 0.0282 | 8.85 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on ORMD-0801 (Insulin) Capsule 8 mg BD than on Placebo | 23.1 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | ORMD-0801 (Insulin) Capsule 8 mg BD | ORMD-0801 (insulin) capsule Dose: 8 mg BD Dosage Regimen: 1 capsule twice a day (once in the morning approximately 30 to 45 minutes prior to breakfast and no later than 10 AM, and once at night between 8 PM to Midnight and no sooner than 1 hour after dinner) Mode of Administration: Oral~ORMD-0801 (Insulin) capsule 8 mg BD: 8 mg ORMD-0801, 1 capsule, twice a day, once in the morning and once in the evening. | 1 | 21 | EG001 |
| Group 2 | Placebo | Fish oil~Placebo: Matching Placebo | 1 | 11 | EG000 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Placebo Run-In (Week -2) through End-of-Study (Week 16); total of 18 weeks.
Source ClinicalTrials.gov
Trial
- Title
- A Study to Assess the Safety and Efficacy of Oral Insulin in T2DM Patients With Nonalcoholic Steatohepatitis (NASH)
- NCT number
- NCT04618744
- Phases
- PHASE2
- Conditions
- Diabetes Mellitus, Type 2, NASH - Nonalcoholic Steatohepatitis
- Interventions
- ORMD-0801 (Insulin) capsule 8 mg BD, Placebo
- Lead sponsor
- Oramed, Ltd.
- Results first posted
- 2024-08-07
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04618744?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- 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
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
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
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.
For software
Read this comparison from software.
The record is JSON. No key.
GET https://conductscience.org/api/comparisons/v1/NCT04618744-sae