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- Title
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.
- Authors
Riddle, M. C.; Rosenstock, J.; Vlajnic, A.; Gao, L.
- Abstract
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.
- Subjects
TYPE 2 diabetes; INSULIN; HEMOGLOBINS; HYPOGLYCEMIA; CLINICAL medicine
- Publication
Diabetes, Obesity & Metabolism, 2014, Vol 16, Issue 5, p396
- ISSN
1462-8902
- Publication type
Article
- DOI
10.1111/dom.12225