Safety and efficacy of switching thrice-daily treatment with NovoRapid®70Mix (BIAsp70) to BIAsp70 before breakfast and lunch and NovoRapid®30Mix (BIAsp30) before dinner in patients with type 2 diabetes: subgroup analysis of a phase III trial

摘要

NovoRapid®70Mix (BIAsp70) and NovoRapid®30Mix (BIAsp30) are biphasic insulin formulations comprising 70 and 30% rapid-acting and 30 and 70% intermediate-acting insulin, respectively. BIAsp70 given thrice daily (TID) is safe and noninferior to BIAsp30 twice daily in patients with type 2 diabetes. However, some patients may need to switch predinner insulin from BIAsp70 to BIAsp30 to achieve appropriate fasting plasma glucose (FPG) levels. In this 28-week study, patients were initially assigned to receive BIAsp70 TID (BIAsp70-70-70). At week 16, if FPG remained high (130 mg/dl), the predinner dose could be changed to BIAsp30 (BIAsp70-70-30). Overall, 96 of 144 patients (66.7%) switched their predinner insulin to BIAsp30 at week 16, while 48 patients (33.3%) remained on BIAsp70 TID. In BIAsp70-70-30 patients, the daily total insulin dose increased by 1.3 units/day from week 16 to week 28; the predinner dose increased from 17.2 to 20.2 units/day, while the prebreakfast dose decreased from 17.0 to 15.5 units/day. HbA1c in patients who switched and those who did not switch the predinner insulin was 7.65 and 7.54%, respectively, at week 16 and 7.62 and 7.42%, respectively, at week 28. Although the incidence of hypoglycemia was higher in BIAsp70-70-30 patients than in BIAsp70-70-70 patients at week 16, the incidence of hypoglycemia did not increase after switching the insulin formulation. These results suggest that the availability of different combinations of rapid- and intermediate-acting insulin formulations, such as BIAsp70 and BIAsp30, will allow clinicians to better respond to the individual patient’s requirements.