Randomization and study treatment
Participants were randomized in a 1:1 ratio to either active treatment with exenatide (Byetta) or placebo using a computer-generated randomization list generated by the Birmingham Clinical Trials Unit. Treatment allocation was blinded to patient and investigators. A double check of allocation was performed by an unblinded nurse and pharmacist. The first dose was a loading dose of subcutaneous exenatide 20 μg or equivalent volume of subcutaneous 0.9% saline placebo. Subjects were then dosed for 12 weeks (self-administered at home) with either subcutaneous exenatide 10 μg or equivalent volume of placebo twice daily. There was no provision for access to treatment after the study concluded.