Рабочая группа по диабету, предиабету и сердечно-сосудистым заболеваниям европейского общества кардиологов (ESC) в сотрудничестве с европейской ассоциацией по изучению диабета (EASD).

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OBJECTIVE -To assess efficacy and tolerability of insulin detemir or NPH insulin added to oral therapy for type 2 diabetes in a treat-to-target titration protocol.RESEARCH DESIGN AND METHODS -Individuals (n ϭ 476) with HbA 1c (A1C) 7.5-10.0% were randomized to addition of twice-daily insulin detemir or NPH insulin in a parallel-group, multicenter trial. Over 24 weeks, insulin doses were titrated toward prebreakfast and predinner plasma glucose targets of Յ6.0 mmol/l (Յ108 mg/dl). Outcomes assessed included A1C, percentage achieving A1C Յ7.0%, risk of hypoglycemia, and body weight.RESULTS -At 24 weeks, A1C had decreased by 1.8 and 1.9% (from 8.6 to 6.8 and from 8.5 to 6.6%) for detemir and NPH, respectively (NS). In both groups, 70% of participants achieved an A1C Յ7.0%, but the proportion achieving this without hypoglycemia was higher with insulin detemir than with NPH insulin (26 vs. 16%, P ϭ 0.008). Compared with NPH insulin, the risk for all hypoglycemia with insulin detemir was reduced by 47% (P Ͻ 0.001) and nocturnal hypoglycemia by 55% (P Ͻ 0.001). Mean weight gain was 1.2 kg with insulin detemir and 2.8 kg with NPH insulin (P Ͻ 0.001), and the difference in baseline-adjusted final weight was Ϫ1.58 (P Ͻ 0.001).CONCLUSIONS -Addition of basal insulin to oral drug therapy in people with suboptimal control of type 2 diabetes achieves guideline-recommended A1C values in most people with aggressive titration. Insulin detemir compared with NPH insulin achieves this with reduced hypoglycemia and less weight gain. Diabetes Care 29:1269 -1274, 2006I mproved glycemic control reduces incidence and delays progression of complications in type 2 diabetes (1-4). Treatment guidelines generally advocate HbA 1c (A1C) targets of 6.5% (5), but clinical audits/studies suggest that many have difficulty achieving and maintaining such goals (6 -8). An important contributory factor is a resistance to initiate insulin on the part of people with diabetes and caregivers. Insulin is usually added only after oral glucose-lowering drugs (OGLDs) fail to curtail hyperglycemia over extended periods, often when A1C exceeds 9.0% (9).Delays in insulin initiation arise from fear of injections, psychological issues such as nonacceptance of treatment failure, and concerns about hypoglycemia and weight gain (10 -12). However, blood glucose control is improved by introduction of insulin therapy (13). Insulin analogs have favorably shifted the achievable balance between glucose control and tolerability. In a recent study in which insulin glargine or NPH insulin was added to OGLDs with intensive titration, mean A1C was reduced from ϳ8.6% to just under 7.0% during 24 weeks, with 60% of patients achieving A1C Ͻ7.0% (14). The analog recipients benefited from reduced hypoglycemia, but there was no between-treatment difference in weight gain.The present study used a similar treat-to-target design. Insulin detemir is an acylated insulin analog achieving extended action through self-association and reversible albumin binding (15). This and its solubility un...

AimsTo compare the efficacy and safety of new insulin glargine 300 U/ml (Gla-300) with that of glargine 100 U/ml (Gla-100) in insulin-naïve people with type 2 diabetes using oral glucose-lowering drugs.MethodsThe EDITION 3 study was a multicentre, open-label, parallel-group study. Participants were randomized to Gla-300 or Gla-100 once daily for 6 months, discontinuing sulphonylureas and glinides, with a dose titration aimed at achieving pre-breakfast plasma glucose concentrations of 4.4–5.6 mmol/l (80–100 mg/dl). The primary endpoint was change in glycated haemoglobin (HbA1c) from baseline to month 6. The main secondary endpoint was percentage of participants with ≥1 nocturnal confirmed [≤3.9 mmol/l (≤70 mg/dl)] or severe hypoglycaemia from week 9 to month 6. Other measures of glycaemia and hypoglycaemia, weight change and insulin dose were assessed.ResultsRandomized participants (n = 878) had a mean (standard deviation) age of 57.7 (10.1) years, diabetes duration 9.8 (6.4) years, body mass index 33.0 (6.7) kg/m2 and HbA1c 8.54 (1.06) % [69.8 (11.6) mmol/mol]. HbA1c levels decreased by equivalent amounts with the two treatments; the least squares mean difference in change from baseline was 0.04 [95% confidence interval (CI) −0.09 to 0.17] % or 0.4 (−1.0 to 1.9) mmol/mol. Numerically fewer participants reported ≥1 nocturnal confirmed (≤3.9 mmol/l) or severe hypoglycaemia from week 9 to month 6 [relative risk (RR) 0.89 (95% CI 0.66 to 1.20)] with Gla-300 versus Gla-100; a significantly lower risk of hypoglycaemia with this definition was found over the 6-month treatment period [RR 0.76 (95% CI 0.59 to 0.99)]. No between-treatment differences in adverse events were identified.ConclusionsGla-300 is as effective as Gla-100 in reducing HbA1c in insulin-naïve people with type 2 diabetes, with lower hypoglycaemia risk.