Comparison · NCT03106870-sae
Oral Metformin and Insulin vs Insulin Therapy Only: 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. Oral Metformin and Insulin vs Insulin Therapy Only: serious adverse events. Trial comparisons, record NCT03106870-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03106870-sae
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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 | 0 | 0.11 | wilson | |
| Risk in group 2 | 0 | 0 | 0.11 | wilson | |
| Risk difference, group 1 minus group 2 | 0 | -0.11 | 0.11 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | log | a group has no participants with the outcome | |||
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to harm | from the risk difference interval | the two groups' risks are equal |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Oral Metformin and Insulin | Intervention 'Insulin Mixtard' and Intervention 'metformin' had included~Insulin Mixtard: Insulin dose:~* 0.7 IU/Kg (at the second trimester of pregnancy).~* 0.8 IU/Kg (at the third trimester of pregnancy). Insulin dose was raised at a rate of 1 IU for every 10 mg/dl higher than the target blood glucose concentration.~Metformin: Oral metformin at a dose of 1500 mg divided into three doses, were taken with meals, in addition to insulin.~If the target blood glucose concentrations were not attained, the dose of metformin was raised to 2000 mg per day. | 0 | 31 | EG000 |
| Group 2 | Insulin Therapy Only | Intervention 'Insulin Mixtard' had included~Insulin Mixtard: Insulin dose:~* 0.7 IU/Kg (at the second trimester of pregnancy).~* 0.8 IU/Kg (at the third trimester of pregnancy). Insulin dose was raised at a rate of 1 IU for every 10 mg/dl higher than the target blood glucose concentration. | 0 | 31 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Source ClinicalTrials.gov
Trial
- Title
- Adding Metformin to Insulin in Controlling Pregestational and Gestational Diabetes Mellitus
- NCT number
- NCT03106870
- Phases
- NA
- Conditions
- Gestational Diabetes Mellitus in Pregnancy
- Interventions
- Insulin Mixtard, Metformin
- Lead sponsor
- Ain Shams University
- Results first posted
- 2017-06-14
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03106870?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.
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