Trial · NCT01991197
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 16 of 16
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Change in the Psoriasis Area and Severity Index (PASI) From Baseline to 16 Weeks in Psoriasis Patients With Type 2 Diabetes Treated With Sitagliptin Compared to Patients Treated With Gliclazide. | 16 weeks | Psoriasis area and severity index (0-72), higher scores worse outcome |
| Secondary | The Number of Patricipants in the Sitagliptin and Gliclazide Arms With Adverse Events at 32 Weeks. | 32 weeks | Dosage: Sitagliptin: 100mg daily, or 50mg daily for participants with moderate kidney disease Gliclazide: 80-320 mg daily. Secondary outcomes: the number participants with adverse events. |
| Secondary | The Change in Quality of Life Scores From Baseline to 16 Weeks in the Sitagliptin and Gliclazide Arms. | 16 weeks | Dermatology life quality index (a skin related quality of life measure) (0-10), higher score worse outcome EQ-5D Euroqol 5 item quality of life index comprising 5 dimensions mobility, self-care, usual activities, pain, anxiety. An index can be derived from these 5 dimensions by conversion with a table of scores. The maximum score of 1 indicates the best health state and minimum score indicating the worst health outcome -0.594. HADS Hospital anxiety and depression scale 0-16 for anxiety and 0-16 for depression, higher score worse outcome HAQ-8 Stanford 8 item disability scale. Scoring is from 0 (without any difficulty) to 3 (unable to do). The 8 scores from the 8 sections are summed and divided by 8. The result is the disability index (range 0-3 with 25 possible values). A |
| Secondary | The Effects of Treatment With Sitagliptin and Treatment With Gliclazide on Other Efficacy Endpoints. | 16 weeks | Secondary outcomes: d. number or participants who acheived a greater than 50% reduction in PASI from baseline (PASI-50); e. number of participants who achieved PASI-75 and PASI-90. |
| Secondary | The Change in Levels of High Sensitivity C-reactive Protein From Baseline to 16 Weeks in the Sitagliptin and Gliclazide Arms. | 16 weeks | High sensitivity C-reactive protein (range 0 - no maximum) |
| Secondary | The Effects of Treatment With Sitagliptin and Treatment With Gliclazide on the Serum Cytokine Tumour Necrosis Factor Alpha. | 16 weeks | Secondary outcomes: The change in serum concentrations of the cytokines tumour necrosis factor alpha (TNFα) Range: 0-no maximum |
| Secondary | The Change in PASI From Baseline to 32 Weeks in Psoriasis Patients With Type 2 Diabetes Treated With Sitagliptin Compared to Patients Treated With Gliclazide. | baseline and 32 weeks | Psoriasis area and severity index 0-72, higher score worse outcome |
| Secondary | The Change in Weight From Baseline to 16 Weeks in the Sitagliptin and Gliclazide Arms. | 16 weeks | The change in weight from baseline to 16 weeks measured in kg |
| Secondary | The Change in Levels of Systolic Blood Pressure From Baseline to 16 Weeks in the Sitagliptin and Gliclazide Arms. | 16 weeks | The change in systolic blood pressure from baseline to 16 weeks measured in kg |
| Secondary | The Change in Levels of Serum Glucose From Baseline to 16 Weeks in the Sitagliptin and Gliclazide Arms. | 16 weeks | The change in glucose from baseline to 16 weeks |
| Secondary | The Change in Levels of Total Cholesterol From Baseline to 16 Weeks in the Sitagliptin and Gliclazide Arms. | 16 weeks | The change in total cholesterol from baseline to 16 weeks |
| Secondary | The Effects of Treatment With Sitagliptin and Treatment With Gliclazide From Baseline to 16 Weeks on Serum Levels Interleukin-23. | 16 weeks | Secondary outcomes: The change in serum concentrations of the cytokine interleukin-23 (IL-23) Range: 0-no maximum |
| Secondary | The Effects of Treatment With Sitagliptin and Treatment With Gliclazide From Baseline to 16 Weeks on Serum Levels Interleukin-17. | 16 weeks | Secondary outcomes: The change in serum concentrations of the cytokine interleukin-17 (IL-17) Range: 0-no maximum |
| Secondary | The Effects of Treatment With Sitagliptin and Treatment With Gliclazide on the Change in Serum Leptin From Baseline to 16 Weeks. | 16 weeks | Secondary outcomes: The change in serum concentrations of the adipokine leptin Range: 0-no maximum |
| Other | The Effect of Treatment With Sitagliptin and With Gliclazide From Baseline to 16 Weeks on the Change in Interleukin-17 Levels in the Skin (in a Sub-group of Participants Willing to Undergo Skin Biopsies). | 16 weeks | Interleukin 17 levels in skin (0-no maximum) |
| Other | The Effect of Treatment With Sitagliptin and With Gliclazide From Baseline to 16 Weeks on the Change in Dipeptidyl Peptidase-4 Levels in the Skin (in a Sub-group of Participants Willing to Undergo Skin Biopsies). | 16 weeks | Dipeptidyl peptidase-4 levels levels in skin (0-no maximum) |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
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
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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