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Comparison of different insulin protocols for type 2 diabetes
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Many patients with type 2 diabetes mellitus (T2DM) initiate insulin therapy when other treatments fail; how best to do this is poorly defined. 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. A very interesting human Investigation!
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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.
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.
Source: Riddle, M. C., Rosenstock, J., Vlajnic, A. and Gao, L. (2014), 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. Diabetes, Obesity and Metabolism, 16: 396–402. doi: 10.1111/dom.12225
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