Effects of darapladib on experimental skin blisters in type 2 diabetes
Research type
Research Study
Full title
An Open Label Study on the Effects of a Short Course of SB480848 (Darapladib) on Contents of Cantharidin-Induced Inflammatory Blisters in Subjects with Type 2 Diabetes Mellitus
IRAS ID
142102
Contact name
Sujith Madhavan
Contact email
Sponsor organisation
GlaxoSmithKline Research & Development
Eudract number
2013-004021-86
ISRCTN Number
n/a
Clinicaltrials.gov Identifier
n/a
Research summary
Darapladib is a new medicine under development by GlaxoSmithKline (GSK) as a potential treatment to reduce major cardiovascular events in patients with heart disease. Darapladib has been studied in more than 16000 participants in clinical trials, at doses up to 160mg, for up to 4 years dosing. This includes 20 to 160 mg for 3 months in 36 patients with Type 2 Diabetes.
Darapladib reduces the activity of the enzyme called Lp-PLA2, which is associated with the inflammation involved in cardiovascular events. In the body, certain cells known as macrophages react to injury or disease by encouraging further inflammation, whereas other macrophages encourage healing. It is thought that darapladib may change the proportions of these macrophages, which can be measured in blister fluid. To do this, trained professionals will induce blisters safely and in a controlled manner with the wart remover cantharidine, in the skin of the forearm, and collect fluid from it with a small needle, which is an established experimental method. This will help us better understand the mechanism of action of Darapladib in the human body especially in people with Diabetes.
The study consists of Part A in about 8 people with Type 2 Diabetes Mellitus (T2DM) and (possibly) Part B in 8 healthy volunteers. Total duration of the study will be approximately 16 weeks. Blisters will be induced, and fluid collected, prior to treatment in eligible participants. The treatment period will start approximately 4 weeks later once the previous blisters have healed). The participants will take 160 mg of darapladib daily for 11 days, and blisters will be induced on Day 10.
The study is sponsored by GlaxoSmithKline and will be conducted in the GSK Clinical Unit Cambridge, a specialist clinical research unit in the UK, with adequate safety and compliance facilities.REC name
South Central - Oxford B Research Ethics Committee
REC reference
14/SC/0021
Date of REC Opinion
6 Feb 2014
REC opinion
Further Information Favourable Opinion