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Clinical Trial Details

Trial ID: L6941
Source ID: NCT01991197
Associated Drug: Sitagliptin
Title: Dipeptidyl Peptidase-4 Inhibition in Psoriasis Patients With Diabetes (DIP): A Randomized Clinical Trial.
Acronym: DIP
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01991197/results
Conditions: Psoriasis|Type 2 Diabetes Mellitus
Interventions: DRUG: Sitagliptin|DRUG: Gliclazide|DRUG: Sitagliptin matched placebo|DRUG: Gliclazide matched placebo capsule
Outcome Measures: 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., Psoriasis area and severity index (0-72), higher scores worse outcome, 16 weeks | Secondary: The Number of Patricipants in the Sitagliptin and Gliclazide Arms With Adverse Events at 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., 32 weeks|The Change in Quality of Life Scores From Baseline to 16 Weeks in the Sitagliptin and Gliclazide Arms., 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, 16 weeks|The Effects of Treatment With Sitagliptin and Treatment With Gliclazide on Other Efficacy Endpoints., 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., 16 weeks|The Change in Levels of High Sensitivity C-reactive Protein From Baseline to 16 Weeks in the Sitagliptin and Gliclazide Arms., High sensitivity C-reactive protein (range 0 - no maximum), 16 weeks|The Effects of Treatment With Sitagliptin and Treatment With Gliclazide on the Serum Cytokine Tumour Necrosis Factor Alpha., Secondary outcomes: The change in serum concentrations of the cytokines tumour necrosis factor alpha (TNFα) Range: 0-no maximum, 16 weeks|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., Psoriasis area and severity index 0-72, higher score worse outcome, baseline and 32 weeks|The Change in Weight From Baseline to 16 Weeks in the Sitagliptin and Gliclazide Arms., The change in weight from baseline to 16 weeks measured in kg, 16 weeks|The Change in Levels of Systolic Blood Pressure From Baseline to 16 Weeks in the Sitagliptin and Gliclazide Arms., The change in systolic blood pressure from baseline to 16 weeks measured in kg, 16 weeks|The Change in Levels of Serum Glucose From Baseline to 16 Weeks in the Sitagliptin and Gliclazide Arms., The change in glucose from baseline to 16 weeks, 16 weeks|The Change in Levels of Total Cholesterol From Baseline to 16 Weeks in the Sitagliptin and Gliclazide Arms., The change in total cholesterol from baseline to 16 weeks, 16 weeks|The Effects of Treatment With Sitagliptin and Treatment With Gliclazide From Baseline to 16 Weeks on Serum Levels Interleukin-23., Secondary outcomes: The change in serum concentrations of the cytokine interleukin-23 (IL-23) Range: 0-no maximum, 16 weeks|The Effects of Treatment With Sitagliptin and Treatment With Gliclazide From Baseline to 16 Weeks on Serum Levels Interleukin-17., Secondary outcomes: The change in serum concentrations of the cytokine interleukin-17 (IL-17) Range: 0-no maximum, 16 weeks|The Effects of Treatment With Sitagliptin and Treatment With Gliclazide on the Change in Serum Leptin From Baseline to 16 Weeks., Secondary outcomes: The change in serum concentrations of the adipokine leptin Range: 0-no maximum, 16 weeks | 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)., Interleukin 17 levels in skin (0-no maximum), 16 weeks|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)., Dipeptidyl peptidase-4 levels levels in skin (0-no maximum), 16 weeks
Sponsor/Collaborators: Sponsor: University College Dublin
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 20
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2014-04
Completion Date: 2016-01
Results First Posted: 2020-05-14
Last Update Posted: 2020-05-14
Locations: The Adelaide and Meath Hospital, Dublin 24, Ireland|UCD Clinical Research Centre, St Vincent's University Hospital,, Dublin 4, Ireland
URL: https://clinicaltrials.gov/show/NCT01991197