Comparison · NCT01779375-sae
Metformin Alone vs Glargine Followed by Metformin: 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. Metformin Alone vs Glargine Followed by Metformin: serious adverse events. Trial comparisons, record NCT01779375-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01779375-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 | 0.106 | 0.0463 | 0.226 | wilson | |
| Risk in group 2 | 0.0455 | 0.0126 | 0.151 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0609 | -0.0608 | 0.185 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 2.34 | 0.478 | 11.4 | log | |
| Odds ratio, group 1 over group 2 | 2.5 | 0.459 | 13.6 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Metformin Alone than on Glargine Followed by Metformin | 16.4 | from the risk difference interval | the interval includes no difference |
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 | Metformin Alone | Metformin was titrated beginning at 500 mg/day to the maximum dose tolerated (up to 2000 mg/day). | 5 | 47 | EG000 |
| Group 2 | Glargine Followed by Metformin | Basal insulin glargine was titrated to achieve a morning fasting blood glucose of 85-95 mg/dl and continued through 3 months after which metformin was titrated as in the Metformin alone arm and continued for 9 months. | 2 | 44 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Throughout the 21 month study period
Source ClinicalTrials.gov
Trial
- Title
- RISE Pediatric Medication Study
- NCT number
- NCT01779375
- Phases
- PHASE3
- Conditions
- Prediabetes, Type 2 Diabetes
- Interventions
- Metformin, Glargine
- Lead sponsor
- RISE Study Group
- Results first posted
- 2018-10-09
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01779375?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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