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Randomized, 1‐year comparison of three ways to initiate and advance insulin for type 2 diabetes: twice‐daily premixed insulin versus basal insulin with either basal‐plus one prandial insulin or basal‐bolus up to three prandial injections
Author(s) -
Riddle M. C.,
Rosenstock J.,
Vlajnic A.,
Gao L.
Publication year - 2014
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.12225
Subject(s) - insulin aspart , medicine , insulin , insulin glargine , endocrinology , discontinuation , basal (medicine) , diabetes mellitus , insulin detemir , type 2 diabetes , nph insulin , type 2 diabetes mellitus , hypoglycemia
Aim Many patients with type 2 diabetes mellitus ( T2DM ) initiate insulin therapy when other treatments fail; how best to do this is poorly defined. Methods People with T2DM [n = 588; glycated haemoglobin A1C ( A1C ) >7.0%, mean baseline 9.4%] were randomized to twice‐daily premixed protamine‐aspart/aspart insulin ( PM − 2), once‐daily insulin glargine plus zero to one prandial insulin glulisine injection (G + 1), or insulin glargine plus zero to three prandial injections (G + 3). Insulin was titrated for 60 weeks. Efficacy and safety outcomes were assessed. Results Discontinuation rates were 53 of the 194 (27%), 44 of the 194 (23%) and 38 of the 194 (20%), for PM − 2, G + 1 and G + 3. Glycaemic control improved in all groups ( A1C 7.2 ± 1.37, 7.1 ± 1.68 and 7.0 ± 1.21% at 60 weeks; 7.5 ± 1.29, 7.2 ± 1.62 and 7.2 ± 1.63% at endpoint). G + 1 was statistically non‐inferior to PM − 2 in reducing A1C . G + 3 was slightly superior to PM − 2 in attaining <7.0% at 60 weeks, but only when the analysis included Good Clinical Practice non‐adherent sites. Hypoglycaemia with plasma glucose <2.8 mmol/l was more frequent with PM − 2 versus G + 1 and G + 3; [adjusted incidence: 46 (p = 0.0087) vs. 33 (p = 0.0045) and 31.5%; events per patient‐year: 1.9 vs. 0.8 and 0.9, p ≤ 0.0001]. Insulin dosage and weight‐gain were similar. Conclusion Basal insulin plus a single prandial injection is as effective in improving glycaemic control as premixed insulin. Full basal‐prandial therapy is only slightly more effective than premixed insulin. Stepwise basal‐prandial regimens improve glycaemic control with less hypoglycaemia than twice‐daily premixed insulin.