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首页> 外文期刊>Diabetes care >A 26-week, randomized, parallel, treat-to-target trial comparing insulin detemir with NPH insulin as add-on therapy to oral glucose-lowering drugs in insulin-naive people with type 2 diabetes.
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A 26-week, randomized, parallel, treat-to-target trial comparing insulin detemir with NPH insulin as add-on therapy to oral glucose-lowering drugs in insulin-naive people with type 2 diabetes.

机译：这项为期26周的随机，平行，以治疗为目标的试验，比较了未使用胰岛素的2型糖尿病患者中将Detemir胰岛素与NPH胰岛素作为口服降糖药的补充疗法。

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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 = 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 < or =6.0 mmol/l (< or =108 mg/dl). Outcomes assessed included A1C, percentage achieving A1C < or =7.0%, 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 < or =7.0%, but the proportion achieving this without hypoglycemia was higher with insulin detemir than with NPH insulin (26 vs. 16%, P = 0.008). Compared with NPH insulin, the risk for all hypoglycemia with insulin detemir was reduced by 47% (P < 0.001) and nocturnal hypoglycemia by 55% (P < 0.001). Mean weight gain was 1.2 kg with insulin detemir and 2.8 kg with NPH insulin (P < 0.001), and the difference in baseline-adjusted final weight was -1.58 (P < 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.
机译：目的：以治疗至目标滴定方案评估在口服治疗中添加的地特胰岛素或NPH胰岛素对2型糖尿病的疗效和耐受性。研究设计与方法：在一项平行组，多中心试验中，将HbA（1c）（A1C）7.5-10.0％的个体（n = 476）随机分配至每天两次两次加用地特米尔或NPH胰岛素。在24周内，将胰岛素剂量滴定至早餐前和晚餐前血浆葡萄糖目标值≤6.0 mmol / l（≤108 mg / dl）。评估的结果包括A1C，达到A1C≤7.0％的百分比，低血糖风险和体重。结果：在第24周时，地特米尔和NPH（NS）的A1C分别降低了1.8和1.9％（从8.6降低到6.8和从8.5降低到6.6％）。在两组中，有70％的参与者达到A1C <或= 7.0％，但是在没有低血糖的情况下，使用Detemir胰岛素的患者要高于使用NPH胰岛素的患者（26 vs. 16％，P = 0.008）。与NPH胰岛素相比，使用地特胰岛素的所有低血糖症的风险降低了47％（P <0.001），夜间低血糖症的风险降低了55％（P <0.001）。地特胰岛素组的平均体重增加为1.2千克，NPH胰岛素组的平均体重增加为2.8千克（P <0.001），基线调整后的最终体重差异为-1.58（P <0.001）。结论：在2型糖尿病控制不佳的人群中，在口服药物治疗中添加基础胰岛素可在大多数积极滴定患者中达到指南推荐的A1C值。与NPH胰岛素相比，地特胰岛素可以减少血糖过低，体重增加较少。

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