Linjawi S, et al. - The researchers compared the efficacy and safety of stepwise insulin intensification with biphasic insulin aspart 30 (BIAsp 30) relative to stepwise intensification with a basal–bolus regimen of insulin glargine (IGlar) and insulin aspart (IAsp) in insulin-naïve patients with type 2 diabetes (T2D). In glycemic control, insulin intensification with BIAsp 30 and basal–bolus demonstrated an improvement. Compared to basal–bolus, the change in HbA_1c was statistically significantly lower for BIAsp 30. A numerically greater rate of overall severe or blood glucose (BG)-confirmed hypoglycemia and a statistically significantly higher rate of severe or BG-confirmed nocturnal hypoglycemia was observed with basal–bolus compared with BIAsp 30.

Methods

• The researchers randomized adults with T2D into 1 of 2 treatment arms for 32 weeks:
  • BIAsp 30 once daily (OD), with the possibility of stepwise treatment intensification up to BIAsp 30 three times daily (TID);
  • Insulin glargine OD, with the possibility of stepwise treatment intensification with insulin aspart up to TID.
• Change from baseline in HbA_1c after 32 weeks was the primary endpoint.

Results

• The estimated mean change in HbA_1c from baseline was statistically significantly lower in the BIAsp 30 arm (- 1.18%) vs basal-bolus (- 1.36%) [estimated treatment difference 0.18%; 95% confidence interval (95% CI) 0.01; 0.36; p < 0.05] after 32 weeks.
• With BIAsp 30 (42.9%), the proportion of patients with HbA_1c below 7.0% was statistically significantly lower compared with basal-bolus (56.9%) (odds ratio 0.58; 95% CI 0.37; 0.89; p=0.01).
• For BIAsp 30, the overall rate of severe or blood glucose (BG)-confirmed hypoglycemic events was numerically lower compared with basal–bolus.
• The researchers observed a statistically significantly lower rate in nocturnal severe or BG-confirmed hypoglycemia in the BIAsp 30 arm relative to basal-bolus: estimated rate ratio 0.32 (95% CI 0.13; 0.79), p=0.0131.
• In both treatment arms, the proportion of patients with adverse events was similar.