Oral Semaglutide vs Placebo: Number of Participants From Randomisation to First Occurrence of a Severe Hypoglycaemic Episode
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 | 0.0158 | 0.0126 | 0.0197 | wilson | ClinicalTrials.gov | |
| Risk in group 2 | 0.0174 | 0.0141 | 0.0215 | wilson | ClinicalTrials.gov | |
| Risk difference, group 1 minus group 2 | -0.00166 | -0.00682 | 0.00348 | newcombe hybrid score | ClinicalTrials.gov | |
| Risk ratio, group 1 over group 2 | 0.905 | 0.665 | 1.23 | log | ClinicalTrials.gov | |
| Odds ratio, group 1 over group 2 | 0.903 | 0.661 | 1.24 | log | ClinicalTrials.gov | |
| Number needed to treat, for one fewer participant with the outcome on Oral Semaglutide than on Placebo | 603 | 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 | Oral Semaglutide | Participants were to receive once daily semaglutide tablets with a dose escalation every 4 weeks in doses 3 mg (week 0 to week 4), 7 mg (week 4 to week 8) until maintenance dose of 14 mg was reached and maintained till the end of treatment visit (up to week 260). | 76 | 4,825 | OG000 | ClinicalTrials.gov |
| Group 2 | Placebo | Participants were to receive once daily placebo matching oral semaglutide until end of the treatment visit (up to week 260). | 84 | 4,825 | OG001 | ClinicalTrials.gov |
Outcome 5
| Field | Value | Source |
|---|---|---|
| Type | SECONDARY | ClinicalTrials.gov |
| Title | Number of Participants From Randomisation to First Occurrence of a Severe Hypoglycaemic Episode | ClinicalTrials.gov |
| Description | The number of participants from randomisation to first occurrence of severe hypoglycaemic episodes (such as the seriousness of hypoglycaemia, contributing factors, seizures, and unconsciousness; classified by American Diabetes Association) during in-trial period were reported. In-trial observation period was defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. | ClinicalTrials.gov |
| Time frame | From randomisation (week 0) up to week 265 | ClinicalTrials.gov |
| Population | FAS included all unique randomized participants who were grouped according to the treatment assigned at randomization. | ClinicalTrials.gov |
Trial 8
| Field | Value | Source |
|---|---|---|
| Title | A Heart Disease Study of Semaglutide in Patients With Type 2 Diabetes | ClinicalTrials.gov |
| NCT number | NCT03914326 | ClinicalTrials.gov |
| Phases | PHASE3 | ClinicalTrials.gov |
| Conditions | Diabetes Mellitus, Type 2 | ClinicalTrials.gov |
| Interventions | Semaglutide, Placebo (semaglutide) | ClinicalTrials.gov |
| Lead sponsor | Novo Nordisk A/S | ClinicalTrials.gov |
| Results first posted | 2025-09-22 | ClinicalTrials.gov |
| Results on ClinicalTrials.gov | https://clinicaltrials.gov/study/NCT03914326?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.