Treatment intensification with an insulin degludec (IDeg)/insulin aspart (IAsp) co-formulation twice daily compared with basal IDeg and prandial IAsp in type 2 diabetes: a randomized, controlled phase III trial.

ABSTRACT: To evaluate the efficacy and safety of two insulin intensification strategies for patients with type 2 diabetes previously treated with basal insulin--insulin degludec (IDeg) and insulin aspart (IAsp)--administered as a co-formulation (IDegAsp) or as a basal-bolus regimen (IDeg and IAsp in separate injections).This 26-week, open-label, treat-to-target, phase IIIb, non-inferiority trial randomized patients (1?:?1) to IDegAsp twice daily with main meals (n?=?138; IDegAsp group) or IDeg once daily and IAsp 2-4?times daily (n?=?136; IDeg+IAsp group).After 26 weeks, the mean glycated haemoglobin (HbA1c) level was 7.0% (53?mmol/mol) for the IDegAsp group and 6.8% (51?mmol/mol) for the IDeg+IAsp group (?%HbA1c from baseline -1.31 and -1.50%, respectively). The non-inferiority of IDegAsp versus IDeg+IAsp was not confirmed for mean change in HbA1c [estimated treatment difference (ETD) 0.18, 95% confidence interval (CI) -0.04, 0.41; p?=?non-significant]. No significant differences were observed in the proportion of patients achieving HbA1c <7.0% (56.5 and 59.6%, respectively). IDegAsp treatment resulted in a significantly lower total daily insulin dose, a smaller change in body weight, numerically lower rates of confirmed hypoglycaemia (self-reported plasma glucose <3.1?mmol/l; rate ratio 0.81; p?=?non-significant), and nocturnal confirmed hypoglycaemic episodes (rate ratio 0.80; p?=?non-significant) versus IDeg+IAsp. Patient-reported outcome scores for social functioning were significantly higher for IDegAsp versus IDeg+IAsp (ETD 2.2; 95% CI 0.3, 4.1; p?

SUBMITTER: Rodbard HW 

PROVIDER: S-EPMC5066701 | biostudies-literature | 2016 Mar

REPOSITORIES: biostudies-literature