Diabetes, obesity & metabolism 2017 01 26() doi 10.1111/dom.12892
To compare the safety and efficacy of a simpler titration algorithm for insulin degludec/liraglutide (IDegLira) with that used in previous DUAL trials in insulin-naïve patients with type 2 diabetes. RESEARCH DESIGN AND METHODS This 32-week, open-label, non-inferiority trial randomized adults with type 2 diabetes uncontrolled on metformin ± pioglitazone to receive IDegLira, titrated either once weekly based on the mean of two pre-breakfast plasma glucose (PG) readings (n = 210), or twice weekly based on the mean of three pre-breakfast PG readings (n = 210).
Mean HbA1c decreased from 8.2% (65 mmol/mol) to 6.1% (43 mmol/mol) with once-weekly titration and from 8.1% (65 mmol/mol) to 6.0% (42 mmol/mol) with twice-weekly titration; non-inferiority was confirmed (estimated treatment difference: 0.12% [-0.04; 0.28]95%CI , 1.30 mmol/mol [-0.41; 3.01]95%CI ). Approximately 90% patients achieved HbA1c <7% in each arm. Mean fasting PG was similar after 32 weeks. Weight change was -1.0 kg versus -2.0 kg for once-weekly versus twice-weekly titration. Rates of severe or blood glucose-confirmed symptomatic hypoglycaemia were low in both arms: 0.16 events/patient-year of exposure (PYE) for once-weekly, 0.76 events/PYE for twice-weekly titration. Mean IDegLira dose at 32 weeks was 41 dose steps (41 U IDeg/1.48 mg Lira) for both arms. Overall adverse event rates were 207.8 and 241.3 events/100 PYE with once-weekly and twice-weekly titration. CONCLUSION
A pragmatic titration algorithm with once-weekly adjustments based on two PG readings resulted in a similar safety and glycaemic efficacy profile to that with twice-weekly adjustments based on three preceding PG values in insulin-naïve patients.