Comparison · NCT00377676-0dfac83e
Cycloset vs Placebo: Subjects Experiencing 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. Cycloset vs Placebo: Subjects Experiencing Serious Adverse Events. Trial comparisons, record NCT00377676-0dfac83e. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00377676-0dfac83e
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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 the outcome 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 | OG000 |
| 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 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Subjects Experiencing Serious Adverse Events
- Description
- Number of subjects reporting all-cause Serious Adverse Events (SAEs) for usual drug therapy plus Cycloset vs. that for usual drug therapy (UDT) plus placebo from baseline to week 52.
- Time frame
- From baseline to week 52.
- Population
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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