Randomisation
diabetes
DIABETES
Randomisation was carried out by the King’s Clinical Trials Unit through a web-based randomisation software utilising a minimisation algorithm. Minimisation, including a random component (0.8), was carried out to protect the balance between groups. Factors used in minimisation were centre, BMI (≤42 and >42), use of insulin and diabetes duration (≤5 and >5 years). Participants were randomised to liraglutide or placebo. Once a participant was randomised, the system automatically generated emails to key staff within the study. Unblinded e-mails sent to site pharmacies alerted them to a participant’s treatment arm. The investigational medicinal product (IMP) was packaged with a unique dispensing unit number (DUN), and the pharmacy had a copy of the Total DUN List (TDL) which detailed the identity of each DUN. The pharmacy department used email and TDL to cross-check the trial prescription to ensure that the correct medication was being dispensed to the correct participant. The TDL was not available to any other research team members who remained blinded. Apart from pharmacy staff, all other site staff were blinded to the treatment arm of the participants.