Trial · NCT01991197
Dipeptidyl Peptidase-4 Inhibition in Psoriasis Patients With Diabetes (DIP): A Randomized Clinical Trial.
NCT01991197, Phase 2, Completed, University College Dublin; results first posted 2020-05-14
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Dipeptidyl Peptidase-4 Inhibition in Psoriasis Patients With Diabetes (DIP): A Randomized Clinical Trial. Trials, record NCT01991197. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01991197
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Dipeptidyl Peptidase-4 Inhibition in Psoriasis Patients With Diabetes (DIP): A Randomized Clinical Trial.
- NCT number
- NCT01991197
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 20 participants, actual
- Lead sponsor
- University College Dublin
- Conditions
- Psoriasis, Type 2 Diabetes Mellitus
- Interventions
- Sitagliptin, Gliclazide, Sitagliptin matched placebo, Gliclazide matched placebo capsule
- First posted
- 2013-11-25
- Last updated
- 2020-05-14
- Other registries' IDs
- eudract:2012-005505-51
- Results first posted
- 2020-05-14
- Limitations and caveats
Despite a significant effort to recruit eligible patients (89 screened), we were unable to meet the required target of 40 and recruited 20 participants. Therefore the study was underpowered to achieve its endpoints.
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| 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 | score on a scale | MEDIAN | |
| SECONDARY | The Number of Patricipants in the Sitagliptin and Gliclazide Arms With Adverse Events at 32 Weeks. | 32 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | The Change in Quality of Life Scores From Baseline to 16 Weeks in the Sitagliptin and Gliclazide Arms. | 16 weeks | score on a scale | MEDIAN | |
| SECONDARY | The Effects of Treatment With Sitagliptin and Treatment With Gliclazide on Other Efficacy Endpoints. | 16 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | The Change in Levels of High Sensitivity C-reactive Protein From Baseline to 16 Weeks in the Sitagliptin and Gliclazide Arms. | 16 weeks | µg/ml | MEDIAN | |
| SECONDARY | The Effects of Treatment With Sitagliptin and Treatment With Gliclazide on the Serum Cytokine Tumour Necrosis Factor Alpha. | 16 weeks | pg/ml | MEDIAN | |
| 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 | The change in PASI at 32 weeks | score on a scale | MEDIAN |
| SECONDARY | The Change in Weight From Baseline to 16 Weeks in the Sitagliptin and Gliclazide Arms. | 16 weeks | kg | MEDIAN | |
| OTHER_PRE_SPECIFIED | 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 | Skin cytokine endpoints | dCt | MEDIAN |
| SECONDARY | The Change in Levels of Systolic Blood Pressure From Baseline to 16 Weeks in the Sitagliptin and Gliclazide Arms. | 16 weeks | mmHg | MEDIAN |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 outcomesResults by group44
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| 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. | Sitagliptin | 9.5 | Inter-Quartile Range 7.8 to 9.6 | score on a scale | |
| 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. | Gliclazide | 9.4 | Inter-Quartile Range 7.6 to 12 | score on a scale | |
| The Number of Patricipants in the Sitagliptin and Gliclazide Arms With Adverse Events at 32 Weeks. | Sitagliptin | 6 | Participants | ||
| The Number of Patricipants in the Sitagliptin and Gliclazide Arms With Adverse Events at 32 Weeks. | Gliclazide | 10 | Participants | ||
| The Change in Quality of Life Scores From Baseline to 16 Weeks in the Sitagliptin and Gliclazide Arms. | Sitagliptin | DLQI | 0.0 | Inter-Quartile Range -1.0 to 1.0 | score on a scale |
| The Change in Quality of Life Scores From Baseline to 16 Weeks in the Sitagliptin and Gliclazide Arms. | Gliclazide | DLQI | -1.0 | Inter-Quartile Range -5.0 to 1 | score on a scale |
| The Change in Quality of Life Scores From Baseline to 16 Weeks in the Sitagliptin and Gliclazide Arms. | Sitagliptin | HAQ-8 | 0.0 | Inter-Quartile Range 0.0 to 0.0 | score on a scale |
| The Change in Quality of Life Scores From Baseline to 16 Weeks in the Sitagliptin and Gliclazide Arms. | Gliclazide | HAQ-8 | 0.0 | Inter-Quartile Range 0.0 to 0.0 | score on a scale |
| The Change in Quality of Life Scores From Baseline to 16 Weeks in the Sitagliptin and Gliclazide Arms. | Sitagliptin | HADS Anxiety | -1 | Inter-Quartile Range -3 to -1 | score on a scale |
| The Change in Quality of Life Scores From Baseline to 16 Weeks in the Sitagliptin and Gliclazide Arms. | Gliclazide | HADS Anxiety | 0 | Inter-Quartile Range -3 to 0 | score on a scale |
1 to 10 of 44Source ClinicalTrials.gov
See all 44 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Sitagliptin | 9 | |
| Overall Study | STARTED | Gliclazide | 11 | |
| Overall Study | COMPLETED | Sitagliptin | 6 | |
| Overall Study | COMPLETED | Gliclazide | 8 | |
| Overall Study | NOT COMPLETED | Sitagliptin | 3 | |
| Overall Study | NOT COMPLETED | Gliclazide | 3 |
Source ClinicalTrials.gov
Adverse events16
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Hypoglycaemia | Endocrine disorders | Sitagliptin | 1 | 9 | 1 |
| other | Hypoglycaemia | Endocrine disorders | Gliclazide | 9 | 11 | 16 |
| other | Respiratory tract infections | Respiratory, thoracic and mediastinal disorders | Sitagliptin | 2 | 9 | 3 |
| other | Respiratory tract infections | Respiratory, thoracic and mediastinal disorders | Gliclazide | 3 | 11 | 5 |
| other | Nasopharyngitis | Respiratory, thoracic and mediastinal disorders | Sitagliptin | 1 | 9 | 1 |
| other | Nasopharyngitis | Respiratory, thoracic and mediastinal disorders | Gliclazide | 2 | 11 | 2 |
| other | Cellulitis | Musculoskeletal and connective tissue disorders | Sitagliptin | 1 | 9 | 1 |
| other | Cellulitis | Musculoskeletal and connective tissue disorders | Gliclazide | 1 | 11 | 2 |
| other | Hyperglycaemia | Endocrine disorders | Sitagliptin | 1 | 9 | 1 |
| other | Hyperglycaemia | Endocrine disorders | Gliclazide | 1 | 11 | 1 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Sitagliptin | 0 | 9 |
| Total, all-cause mortality | Gliclazide | 0 | 11 |
| Total, other adverse events | Sitagliptin | 6 | 9 |
| Total, other adverse events | Gliclazide | 10 | 11 |
| Total, serious adverse events | Sitagliptin | 1 | 9 |
| Total, serious adverse events | Gliclazide | 2 | 11 |
Source ClinicalTrials.gov
Papers23
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Sitagliptin vs Gliclazide: The Number of Patricipants in the Sitagliptin and Gliclazide Arms With Adverse Events at 32 Weeks. | Trial comparisons |
| Sitagliptin vs Gliclazide: deaths from any cause | Trial comparisons |
| Sitagliptin vs Gliclazide: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01991197
GET https://conductscience.org/api/trials/v1/NCT01991197/results?page=2