Comparison · NCT01453049-7c47676f
Rosiglitazone+Glimepiride FDC vs Glimepiride: Number of Participants With a Bone Fracture
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. Rosiglitazone+Glimepiride FDC vs Glimepiride: Number of Participants With a Bone Fracture. Trial comparisons, record NCT01453049-7c47676f. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01453049-7c47676f
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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 | 0 | 0.0876 | wilson | |
| Risk in group 2 | 0 | 0 | 0.082 | wilson | |
| Risk difference, group 1 minus group 2 | 0 | -0.082 | 0.0876 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | log | a group has no participants with the outcome | |||
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to treat | from the risk difference interval | the two groups' risks are equal |
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 | Rosiglitazone+Glimepiride FDC | Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (\>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1). | 0 | 40 | OG000 |
| Group 2 | Glimepiride | Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG \>=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1). | 0 | 43 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants With a Bone Fracture
- Description
- Participants with a break in the continuity (fracture) of the bone were evaluated.
- Time frame
- Week 24/EW
- Population
- Safety Population. Only those participants contributing data at the indicated time points were analyzed.
Source ClinicalTrials.gov
Trial
- Title
- An Efficacy and Safety Study of Fixed-dose Rosiglitazone/Glimepiride to Treat Chinese Type 2 Diabetes Patients
- NCT number
- NCT01453049
- Phases
- PHASE3
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- rosiglitazone/glimepiride fix dose combination, glimepiride
- Lead sponsor
- GlaxoSmithKline
- Results first posted
- 2012-01-13
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01453049?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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