Comparison · NCT03371082-sae
Gan & Lee Insulin Glargine Injection 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. Gan & Lee Insulin Glargine Injection vs Lantus®: serious adverse events. Trial comparisons, record NCT03371082-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03371082-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 | 0.0348 | 0.019 | 0.0629 | wilson | |
| Risk in group 2 | 0.0484 | 0.0291 | 0.0797 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0136 | -0.0486 | 0.0205 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.719 | 0.325 | 1.59 | log | |
| Odds ratio, group 1 over group 2 | 0.709 | 0.31 | 1.62 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Gan & Lee Insulin Glargine Injection than on Lantus® | 73.5 | 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 | Gan & Lee Insulin Glargine Injection | Gan \& Lee Insulin Glargine Injection for subcutaneous injection, 100 U/mL, in the integrated, disposable 3.0-mL pre-filled Gan \& Lee injector pen. Subjects randomized to the Gan \& Lee Insulin Glargine Injection group will participate in the study for 26 weeks.~Gan \& Lee Insulin Glargine Injection: Route of administration: subcutaneous injection | 10 | 287 | EG000 |
| Group 2 | Lantus® | Lantus® (insulin glargine injection) solution for subcutaneous injection, 100 U/mL, in the SoloStar® 3.0 mL pre-filled insulin pen. Subjects randomized to the Lantus® group will participate for 26 weeks.~Lantus®: Route of administration: subcutaneous injection | 14 | 289 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- 26-weeks
Source ClinicalTrials.gov
Trial
- Title
- Gan & Lee Insulin Glargine Target Type (1) Evaluating Research
- NCT number
- NCT03371082
- Phases
- PHASE3
- Conditions
- Diabetes Mellitus, Type 1
- Interventions
- Gan & Lee Insulin Glargine Injection, Lantus®
- Lead sponsor
- Gan and Lee Pharmaceuticals, USA
- Results first posted
- 2024-05-14
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03371082?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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