After 24 weeks, mean change in bodyweight from baseline
was +1.4 kg in the BIAsp BID + Sit group (difference vs. BIAsp QD + Sit: 1.51 [95% CI 0.82; 2.21], P < 0.001), +2.1 kg for BIAsp BID (difference vs. BIAsp QD + Sit: 2.19 [95% CI 1.49; 2.89], P < 0.001) and GSK1210151A supplier −0.1 kg for BIAsp QD + Sit. No significant difference was reported between the two BID groups. Final total daily dose was 0.66 U/kg, 0.72 U/kg and 0.39 U/kg, respectively, from a baseline of 0.16 U/kg. In the BID groups, the morning dose increased from 0.08 U/kg to 0.35 U/kg (BIAsp BID + Sit) and 0.39 U/kg (BIAsp BID), while the evening dose increased from 0.08 U/kg to 0.31 U/kg (BIAsp BID + Sit) and 0.34 U/kg (BIAsp BID). There were no significant differences in TRIM-D scores among the treatment groups. The overall TRIM-D score after 24 weeks was 76.64, 77.79 and 76.46 in the BIAsp BID + Sit, BIAsp QD + Sit and BIAsp BID groups, respectively, with baseline values
of 70.28, 72.40 and 69.30. Average total medicine costs in each arm (in subjects exposed ≥20 weeks) were GBP 345.7 for BIAsp BID + Sit, GBP 287.9 for BIAsp QD + Sit and GBP 160.0 for BIAsp BID. No further cost analyses were conducted. Clinicians need to balance risks, costs and benefits of different treatment approaches when choosing a suitable treatment plan for patients with diabetes. Moreover, individual circumstances should be considered, i.e. age, comorbidities, baseline HbA1c, ability to RAD001 adhere to complex regimens, to optimize outcomes when choosing an antihyperglycaemic strategy [2]. Sit2Mix included a relatively homogenous population at baseline and investigated three distinct intensification regimens in patients with T2D failing to be controlled on sitagliptin and metformin in combination with other OADs. All regimens were efficacious and well tolerated after 24 weeks of treatment, these but each presented a different profile in terms of treatment benefits
and risks. The BIAsp BID + Sit regimen showed greater improvement in glycaemic control versus BIAsp QD + Sit and BIAsp BID. Nevertheless, HbA1c change in both the BIAsp QD + Sit and BIAsp BID groups was ≥1.0% and a change of this magnitude is associated with reduced risk for microvascular and macrovascular complications [14]. The improvement observed in mean SMPG after breakfast and lunch, and before lunch and dinner, in the BID groups is likely a reflection of the different dose-administration timings with BID and QD regimens (dosing before breakfast and dinner vs. dosing before dinner only, respectively). Although a greater proportion of patients achieved the recommended HbA1c target <7.0% in the BIAsp BID + Sit group (approximately 60%) versus the other groups, this trend was not maintained upon examination of those patients who achieved target without hypoglycaemia. For this endpoint, the proportions of responders in the BIAsp BID + Sit and BIAsp QD + Sit groups were comparable (39–41.