在 2 型糖尿病患者中，起始每日一次地特胰岛素治疗与体重增加无关：一项观察性研究的结果。
Initiation of once daily insulin detemir is not associated with weight gain in patients with type 2 diabetes mellitus: results from an observational study.
机构信息
McGill Nutrition and Food Science Centre, Royal Victoria Hospital, Montreal, Quebec, Canada.
出版信息
Diabetol Metab Syndr. 2013 Oct 2;5(1):56. doi: 10.1186/1758-5996-5-56.
BACKGROUND
Obesity is common in type 2 diabetes (T2DM) and is associated with increased risk of morbidity and all-cause mortality. This analysis describes weight changes associated with insulin detemir initiation in real-life clinical practice.
METHODS
Study of Once-Daily Levemir (SOLVE) was a 24-week international observational study of once-daily insulin detemir as add-on therapy in patients with T2DM receiving oral hypoglycaemic agents (OHAs).
RESULTS
17,374 participants were included in the analysis: mean age 62 ± 12 years; weight 80.8 ± 17.6 kg; body mass index (BMI) 29.2 ± 5.3 kg/m2; diabetes duration 10 ± 7 years; HbA1c 8.9 ± 1.6%. HbA1c decreased by 1.3 ± 1.5% during the study, with insulin doses of 0.27 ± 0.17 IU/kg. Patients with higher BMI had higher pre-insulin HbA1c, and similar reductions in HbA1c with insulin therapy. Weight decreased from 80.8 ± 17.6 kg to 80.3 ± 17.0 kg (change of -0.6 [95% CI -0.65; -0.47] kg), with 35% of patients losing >1 kg. Patients with the highest pre-insulin BMI lost the greatest amount of weight: BMI < 25: +0.8 [95% CI: 0.6; 0.9] kg, 25 ≤ BMI < 30: -0.2 [95% CI: -0.3; -0.8] kg, 30 ≤ BMI < 35: -1.0 [95% CI: -1.1; -0.8] kg; BMI ≥ 35: -1.9 [95% CI: -2.2; -1.6] kg. Minor hypoglycaemia decreased with increasing BMI: 2.3 and 1.3 events per patient year for BMI <25 and ≥ 35, respectively.
CONCLUSIONS
Overall, patients with poorly controlled T2DM achieved significant reductions in HbA1c after initiation of once-daily insulin detemir therapy, without weight gain. The favourable impact of insulin detemir on weight may not apply to other insulin preparations.
TRIAL REGISTRATIONS
ClinicalTrials.gov, NCT00825643 and NCT00740519.
背景
肥胖在 2 型糖尿病（T2DM）中很常见，与发病率和全因死亡率的增加相关。本分析描述了在真实临床实践中使用胰岛素地特胰岛素治疗时体重的变化。
方法
每日一次 Levemir（SOLVE）研究是一项为期 24 周的国际观察性研究，评估了每日一次胰岛素地特胰岛素作为口服降糖药（OHA）治疗的 T2DM 患者的附加疗法。
结果
共纳入 17374 名参与者：平均年龄 62±12 岁；体重 80.8±17.6kg；体重指数（BMI）29.2±5.3kg/m2；糖尿病病程 10±7 年；糖化血红蛋白（HbA1c）8.9±1.6%。研究期间 HbA1c 下降了 1.3±1.5%，胰岛素剂量为 0.27±0.17IU/kg。BMI 较高的患者有更高的胰岛素前 HbA1c，并且胰岛素治疗时 HbA1c 降低相似。体重从 80.8±17.6kg 降至 80.3±17.0kg（-0.6[95%CI-0.65；-0.47]kg），35%的患者体重减轻超过 1kg。胰岛素前 BMI 最高的患者体重减轻最多：BMI<25：+0.8[95%CI：0.6；0.9]kg，25≤BMI<30：-0.2[95%CI：-0.3；-0.8]kg，30≤BMI<35：-1.0[95%CI：-1.1；-0.8]kg；BMI≥35：-1.9[95%CI：-2.2；-1.6]kg。随着 BMI 的增加，低血糖事件减少：BMI<25 和 BMI≥35 的患者每年每人分别发生 2.3 和 1.3 次事件。
结论
总体而言，接受每日一次胰岛素地特胰岛素治疗的控制不佳的 T2DM 患者 HbA1c 显著降低，体重无增加。胰岛素地特胰岛素对体重的有利影响可能不适用于其他胰岛素制剂。
试验注册
ClinicalTrials.gov，NCT00825643 和 NCT00740519。
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