NN-ExFiasp®
Research type
Research Study
Full title
A trial investigating the effect on blood glucose after the injection of fast-acting insulin aspart (Fiasp®) in comparison to insulin aspart (NovoRapid®) around exercise in participants with type 1 diabetes
IRAS ID
254422
Contact name
Othmar Moser
Contact email
Sponsor organisation
ABMU Health Board
Eudract number
2018-004092-12
ISRCTN Number
ISRCTN00000000
Clinicaltrials.gov Identifier
DRKS00015855
Duration of Study in the UK
1 years, 10 months, 0 days
Research summary
The study will compare changes in blood glucose concentrations of Fiasp® and NovoRapid® for the same pre- and post-exercise dose reduction (for both 2 x 50% and 2 x 75% reduced short-acting insulin dose) during exercise in 44 patients with type 1 diabetes (T1D) in a randomised, single-centre, double blind, four-period cross-over, twice dose trial. In this study, changes in several physiological markers, and blood markers before, during, and after exercise will be observed. The aim of this study is to help develop recommendations on how to adapt insulin therapy to achieve glucose control while exercising, in patients with type 1 diabetes. The study will recruit physically active individuals (18-65 years) with type 1 diabetes and will be based at the JCRF NHS study site in Swansea University. Participants who have been successfully screened will attend four main trial days. The trial days focus on the reduced bolus insulin doses of either Fiasp® or NovoRapid® at breakfast and lunch meals, separated by a 45 min session of moderate intensity aerobic exercise on a cycle ergometer. To compare effects of, and on, the insulins, blood tests will be taken at regular intervals (5 min, 10 min, and 15 min) throughout the visit.
REC name
Wales REC 3
REC reference
18/WA/0421
Date of REC Opinion
15 Jan 2019
REC opinion
Further Information Favourable Opinion