Comparison · NCT01991197-sae
Sitagliptin vs Gliclazide: 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. Sitagliptin vs Gliclazide: serious adverse events. Trial comparisons, record NCT01991197-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01991197-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 | 0.111 | 0.0199 | 0.435 | wilson | |
| Risk in group 2 | 0.182 | 0.0514 | 0.477 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0707 | -0.38 | 0.278 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.611 | 0.0655 | 5.7 | log | |
| Odds ratio, group 1 over group 2 | 0.563 | 0.0425 | 7.44 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Sitagliptin than on Gliclazide | 14.1 | 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 | Sitagliptin | Double blind phase (week 0-16):~Sitagliptin two 50mg tablets (or one 50mg in participants with moderate kidney disease) once daily for 16 weeks.~Placebo Comparator: Gliclazide matched placebo One gliclazide matched placebo capsule daily for 4 weeks. If no severe hypoglycaemic episodes one gliclazide matched placebo capsule twice daily for 4 weeks. If no severe hypoglycaemic episodes two gliclazide matched placebo capsules twice daily for 8 weeks.~Open-label phase (week 16-32):~Sitagliptin two 50mg tablets (or one 50mg in participants with moderate kidney disease) once daily for 16 weeks. | 1 | 9 | EG000 |
| Group 2 | Gliclazide | Double-blind phase (week 0-16):~Gliclazide 80mg once daily for 4 weeks Then if no severe hypoglycaemic episodes increase to Gliclazide 80mg twice daily for 4 weeks.~Then if no severe hypoglycaemic episodes increase to Gliclazide 160mg twice daily for 8 weeks Placebo Comparator: Sitagliptin matched placebo Two tablets (or one tablet in participants with moderate kidney disease) once daily for 16 weeks.~Open-label phase (week 16-32):~Sitagliptin two 50mg tablets (or one 50mg in participants with moderate kidney disease) once daily for 16 weeks. | 2 | 11 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Participants attended the clinical research centre 9 times over the course of 40 weeks and adverse event data was collected at each visit after the baseline visit.
Source ClinicalTrials.gov
Trial
- Title
- Dipeptidyl Peptidase-4 Inhibition in Psoriasis Patients With Diabetes (DIP): A Randomized Clinical Trial.
- NCT number
- NCT01991197
- Phases
- PHASE2
- Conditions
- Psoriasis, Type 2 Diabetes Mellitus
- Interventions
- Sitagliptin, Gliclazide, Sitagliptin matched placebo, Gliclazide matched placebo capsule
- Lead sponsor
- University College Dublin
- Results first posted
- 2020-05-14
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01991197?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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