Sit2Mix is a 24-week, randomised, controlled, open-label trial comparing efficacy and safety of twice-daily BIAsp 30 plus sitagliptin (BIAsp BID+Sit, n=195), once-daily BIAsp 30 plus sitagliptin (BIAsp QD+Sit, n=193) and twice-daily BIAsp 30 without sitagliptin (BIAsp BID, n=194), all with metformin, in patients with type 2 diabetes (T2D) inadequately controlled on sitagliptin and metformin. At baseline, age, diabetes duration, BMI, FPG and HbA1c (8.4% [68 mmol/mol]) were similar across groups. After 24 weeks, HbA1c reduction (% [mmol/mol]) was statistically superior with BIAsp BID+Sit vs. BIAsp QD+Sit (–1.51 [–16.5] vs. –1.15 [–12.6], difference: –0.36 [–3.89], 95% CI –0.54;–0.17 [–5.91;–1.88], p<0.001) and vs. BIAsp BID (vs. –1.27 [–13.8], diff: 0.24 [2.65], 95% CI 0.06;0.43 [0.62;4.68], p=0.01); BIAsp QD+Sit and BIAsp BID were not significantly different. A similar trend was seen for HbA1c responders <7.0%; 59.8% of patients achieved target with BIAsp BID+Sit, 46.5% with BIAsp QD+Sit, 49.7% with BIAsp BID. Severe or minor hypoglycaemia (PG <56 mg/dL ± symptoms) was significantly different with BIAsp QD+Sit vs. BIAsp BID (p=0.015); rates: 1.17 events/patient-year with BIAsp QD+Sit, 1.50 with BIAsp BID+Sit, 2.24 with BIAsp BID. Other adverse events were similar across groups. Treatment difference in body weight change significantly favoured BIAsp QD+Sit vs. both BID groups (vs. BIAsp BID+Sit 1.51 kg [0.82;2.21], p<0.001; vs. BIAsp BID 2.19 kg [1.49;2.89], p<0.001). Final total daily insulin dose was 0.39, 0.66 and 0.72 U/kg, respectively (baseline 0.16 U/kg). In conclusion, adding BIAsp 30 to patients with T2D inadequately controlled with sitagliptin and metformin is efficacious and has a good tolerability profile; however, while BIAsp BID+Sit was superior in glycaemic control, BIAsp QD+Sit had a lower risk of hypoglycaemia vs. BIAsp BID and less weight gain vs. both BID groups.
Acknowledgements: Novo Nordisk sponsored the Sit2Mix trial and abstract submission.