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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
Author(s) -
Rodbard H. W.,
Cariou B.,
Pieber T. R.,
Endahl L. A.,
Zacho J.,
Cooper J. G.
Publication year - 2016
Publication title -
diabetes, obesity and metabolism
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.445
H-Index - 128
eISSN - 1463-1326
pISSN - 1462-8902
DOI - 10.1111/dom.12609
Subject(s) - insulin degludec , medicine , endocrinology , insulin aspart , type 2 diabetes , insulin , basal (medicine) , diabetes mellitus , basal insulin
Aims 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). Methods 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). Results 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 (Δ% 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 < 0.05). Conclusions Both intensification strategies effectively improved glycaemic control. Although non‐inferiority was not confirmed, there were no significant differences between the groups that could affect clinical utility.