De‐intensification of basal‐bolus therapy by replacing prandial insulin with once‐weekly subcutaneous semaglutide in individuals with well‐controlled type 2 diabetes: A single‐centre, open‐label randomised trial (TRANSITION‐T2D)

Abstract Aims The study aims to examine the outcome of replacement of prandial insulin with once‐weekly subcutaneous semaglutide in people with type 2 diabetes reasonably controlled on multiple daily insulin injections (MDI). Materials and Methods This single‐centre, randomised, open‐label trial enrolled a statistically predetermined sample of 60 adults with HbA1c ≤7.5% (58 mmol/mol) receiving MDI, with a total daily dose (TDD) ≤120 units/day. Participants were assigned 2:1 to subcutaneous semaglutide 1.0 mg plus insulin degludec, or to continue MDI. The primary outcome was percentage of subjects maintaining HbA1c ≤7.5% (58 mmol/mol) at Week 26. Results At Week 26, 90% of semaglutide and 75% of MDI subjects maintained HbA 1c ≤7.5% (≤58 mmol/mol) ( p = 0.18). Mean changes (95% CI) in HbA 1c , weight and percentage body weight for semaglutide versus MDI, respectively, were −0.5% (−0.7, −0.3) versus 0.0% (−0.3, 0.3; p = 0.009); −8.9 kg (−9.9, −7.8) versus 1.5 kg (−0.1, 3.1; p < 0.001); and −8.6% (−9.6, −7.6) versus 1.4% (0.0, 2.8; p < 0.001). Insulin TDD decreased 56.0% (−62.3, −49.7) with semaglutide and increased 6.7% (−2.5, 16.0) with MDI ( p < 0.001). Among semaglutide subjects, 58% reduced insulin TDD > 50%, 97.5% stopped prandial insulin and 45% lost >10% body weight. Participant treatment satisfaction scores trended higher with semaglutide. Hypoglycaemia frequency was similar between groups. Conclusions In people with type 2 diabetes well controlled (HbA 1c ≤7.5% [≤58 mmol/mol]) on MDI ≤120 units/day, replacing multiple daily injections of prandial insulin with once‐weekly subcutaneous semaglutide can maintain and even improve HbA 1c , lower body weight and lessen the burden of management.