Dipeptidyl Peptidase-4 Inhibition in Psoriasis Patients With Diabetes (DIP): A Randomized Clinical Trial.
Status:
Completed
Trial end date:
2016-01-01
Target enrollment:
Participant gender:
Summary
The primary purpose of this study is to determine if sitagliptin (Januvia®) improves
psoriasis severity after 16 weeks of treatment in 20 participants with both psoriasis and
type 2 diabetes mellitus. We will compare the change in psoriasis severity in 20 participants
treated with Januvia® to 20 participants treated with 16 weeks of a comparator drug
(gliclazide, Diamicron®). Participants will be recruited from two centres and after a 4 week
washout period will be followed prospectively for 36 weeks. Participants will be stratified
by centre, psoriasis severity and obesity status after which they will be randomly allocated
to Arm A or Arm B. Participants will be treated with either Januvia® and Diamicron® matched
placebo capsules (Arm A), or Diamicron® and Januvia® matched placebo tablets (Arm B) for 16
weeks and then proceed to an open-label phase where all participants will receive Januvia®
for a further 16 weeks.
Both the research participants and the investigators will be unaware of the trial arm to
which the research participant has been allocated (double-blind study). Research participants
will be prohibited from making any changes to the dose of medications used to treat
psoriasis. If a participant's plasma glycated haemoglobin level (HbA1c) (reflects a
participant's glucose control over the previous 3 months) is above 64mmol/mol eight weeks
after commencing one of the study investigational medicinal products (IMPs) insulin therapy
will be used to improve glycaemic control.
Participants will be assessed at 9 study visits over 40 weeks. Participants will complete
questionnaires, have a medical history recorded and physical examination, blood sampling and
skin biopsies taken (in a small number of willing participants at 3 visits).
The following endpoints will be analysed:
Changes in psoriasis severity at 16 and 32 weeks; changes in validated quality of life
scores; incidence of adverse events; incidence of discontinuation of one of the study IMPs,
time to relapse of psoriasis; changes in cardiovascular disease risk factor profiles; changes
in cytokines, hormones, expression of immune proteins in blood and skin biopsies; and genetic
profiles that predicts best response to sitagliptin therapy.
We hypothesize that sitagliptin therapy decreases psoriasis severity.