Dipeptidyl peptidase-4 Inhibition in Psoriasis patients with diabetes (DIP): A Randomized Clinical Trial.

niversity College Dublin0 个研究点开始时间: 2013年2月15日最近更新: 2016年4月25日

适应症

试验速览

暂无简介。

•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).

发起方

niversity College Dublin