A study to investigate whether a drug called Januvia, that is licensed to lower blood glucose in diabetic patients, has an effect on psoriasis.
- Conditions
- PsoriasisMedDRA version: 17.1Level: PTClassification code 10037153Term: PsoriasisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disordersTherapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Registration Number
- EUCTR2012-005505-51-IE
- Lead Sponsor
- niversity College Dublin
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
People who satisfy all of the following may be included in the study:
1. Have a diagnosis of generalized chronic plaque and/or guttate psoriasis;
2. Are male or female aged between 18 and 75 years inclusive;
3. Have a psoriasis area and severity index (PASI) greater than 7 at screening or baseline;
4. Have a diagnosis of type 2 diabetes;
5. Have a glycated haemoglobin (HbA1c) level between 48mmol/mol and 80mmol/mol;
6. Are able and willing to stop sulphonylurea, dipeptidyl peptidase-4 [DPP-4] inhibitor and glucagon-like peptide-1 [GLP-1] analogue therapy for the duration of the study;
7. Have a negative pregnancy test at screening (women of child bearing potential only); and
8. Are willing to voluntarily sign a statement of informed consent to participate in the study.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 32
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 8
People with any of the following conditions will be excluded from the study:
1. Allergy or hypersensitivity to Januvia® or Diamicron®;
2. Current or recent (within 8 weeks) receipt of phototherapy;
3. Type 1 diabetes;
4. Severe kidney disease, as defined as an estimated glomerular filtration rate of less than <15ml/min/1.73 m2;
5. Severe heart or liver disease;
6. Any other contraindications, as stated in the SPCs for Januvia® or Diamicron®;
7. Female patients of child bearing potential who are pregnant, breastfeeding, or unwilling to practice an acceptable barrier and/or hormonal method of contraception or abstinence during participation in the study;
8. Any clinically significant chronic disease that might, in the opinion of the investigator, interfere with the evaluations or preclude completion of the trial;
9. Previous randomisation into this study;
10. Concurrent participation in another clinical trial; and
11. Participation in another clinical trial during the twelve weeks prior to study entry (i.e. screening visit).
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method