Comparison · NCT00377676-sae
Cycloset vs Placebo: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. Cycloset vs Placebo: serious adverse events. Trial comparisons, record NCT00377676-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00377676-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 | 0.0857 | 0.0743 | 0.0986 | wilson | |
| Risk in group 2 | 0.0965 | 0.0798 | 0.116 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0108 | -0.0335 | 0.0103 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.888 | 0.702 | 1.12 | log | |
| Odds ratio, group 1 over group 2 | 0.878 | 0.677 | 1.14 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Cycloset than on Placebo | 92.8 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Cycloset | During the first week of the dose titration period, subjects were instructed to take 1 tablet of study drug daily (0.8 mg Cycloset). If the dose was tolerated, subjects were to have their dose of study drug increased to 2 tablets of study drug per day. The daily dose of study drug was to be increased at a rate of 1 tablet per week, up to a target dose level of 6 tablets per day at Week 6. | 176 | 2,054 | EG000 |
| Group 2 | Placebo | During the first week of the dose titration period, subjects were instructed to take 1 tablet of study drug daily (1 placebo tablet). If the dose was tolerated, subjects were to have their dose of study drug increased to 2 tablets of study drug per day. The daily dose of study drug was to be increased at a rate of 1 tablet per week, up to a target dose level of 6 tablets per day at Week 6. | 98 | 1,016 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Expected study duration was 52 weeks. Adverse event data were collected from the day of first treatment dose to within 30 days of the last course of treatment or the date of the last contact (whichever was earlier).
Source ClinicalTrials.gov
Trial
- Title
- Safety and Tolerability Study of Cycloset in Treatment of Type 2 Diabetes
- NCT number
- NCT00377676
- Phases
- PHASE3
- Conditions
- Type 2 Diabetes Mellitus
- Interventions
- Cycloset, Usual Diabetes Therapy plus placebo
- Lead sponsor
- VeroScience
- Results first posted
- 2011-10-28
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00377676?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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