Comparison · NCT02227862-sae
Mylan's Insulin Glargine vs Lantus®: 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. Mylan's Insulin Glargine vs Lantus®: serious adverse events. Trial comparisons, record NCT02227862-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02227862-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 | 0.0643 | 0.041 | 0.0993 | wilson | |
| Risk in group 2 | 0.0791 | 0.0528 | 0.117 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0149 | -0.0592 | 0.029 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.812 | 0.446 | 1.48 | log | |
| Odds ratio, group 1 over group 2 | 0.799 | 0.419 | 1.53 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Mylan's Insulin Glargine than on Lantus® | 67.3 | 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 | Mylan's Insulin Glargine | Receive Mylan's Insulin Glargine plus insulin lispro.~Mylan's insulin glargine: All patients will be shifted from their current mealtime insulin to insulin lispro at the start of the run-in period, and will continue on this for the complete trial. During the 6 week run-in period the doses of Lantus® and insulin lispro will be titrated (if required) to ensure diabetes control. After the run-in period, patients will be randomized to receive either Mylan's insulin glargine (in place of Lantus®), or to continue on Lantus®. During the period from 12 to 24 weeks dose titration will be kept to a minimum. | 18 | 280 | EG000 |
| Group 2 | Lantus® | Receive Lantus® plus insulin lispro~Lantus®: All patients will be shifted from their current mealtime insulin to insulin lispro at the start of the run-in period; and will continue on this for the complete trial. During the 6week run-in period the doses of Lantus® and insulin lispro will be titrated (if required) to ensure diabetes control. After the run-in period, patients will be randomized to receive either Mylan's insulin glargine (in place of Lantus®), or to continue on Lantus®. During the period from 12 to 24 weeks dose titration will be kept to a minimum. | 22 | 278 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- 56 Weeks
Source ClinicalTrials.gov
Trial
- Title
- Non-inferiority Study to Compare the Efficacy and Safety of Mylan's Insulin Glargine With Lantus® in Type 1 Diabetes Mellitus Patients (INSTRIDE 1)
- NCT number
- NCT02227862
- Phases
- PHASE3
- Conditions
- Type 1 Diabetes
- Interventions
- Mylan's insulin glargine, Lantus®
- Lead sponsor
- Mylan Inc.
- Results first posted
- 2020-03-09
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02227862?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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