Schiel R, Müller Ulrich A
Department of Internal Medicine III, University of Jena Medical School, Jena, Germany.
Exp Clin Endocrinol Diabetes. 2007 Nov;115(10):627-33. doi: 10.1055/s-2007-984445.
Addition of the long-acting basal human insulin analogue insulin glargine (LANTUS) to the treatment regimen of patients with inadequate glycaemic control on oral antidiabetic drugs (OADs) alone has previously been evaluated as effective, safe and convenient. This pilot study aimed to establish whether insulin glargine plus OADs is effective in Type 2 diabetes patients previously poorly controlled on premixed insulin therapy.
In an open, controlled, randomized, parallel-group, single-centre, 16-week pilot study, 52 patients (age 65.6+/-9.2 years; diabetes duration 15.3+/-7.6 years; insulin therapy duration 4.2+/-1.7 years, body mass index 31.4+/-2.9 kg/m2) with Type 2 diabetes (HbA1c>or=8.0%) on premixed human insulin (75/25 or 70/30) were randomized to once-daily morning insulin glargine plus glimepiride (Group A; n=17), insulin glargine plus glimepiride and metformin (Group B; n=18) or premixed insulin (Group C; n=17). Glycaemic control and incidence of hypoglycaemia were evaluated.
HbA1c decreased significantly from baseline in Groups A and B, but not in Group C; (Group A: 7.87+/-0.66%, -0.35%, p=0.013; Group B: 7.44+/-0.92%, -0.69%, p=0.0057; Group C: 7.83+/-1.13%, -0.25%, p=0.32). There were no between-treatment differences at endpoint in HbA1c, fasting blood glucose, mean daily blood glucose or symptomatic hypoglycaemia (mean events/patient: Group A, 2.2; Group B, 2.3; Group C, 2.0). At endpoint, 88% of patients in Group A, 81% in Group B and 94% in Group C opted to continue with their assigned regimen.
This pilot study is the first prospective study to show that switching from premixed insulin to insulin glargine plus OAD treatment resulted in similar glycaemic control and treatment satisfaction. The results support the need for prospective examination in a larger-scale clinical study in patients with long-standing Type 2 diabetes and sub-optimal glycaemic control previously using a conventional premixed insulin regimen.
对于仅接受口服抗糖尿病药物（OADs）治疗但血糖控制不佳的患者，在其治疗方案中添加长效基础人胰岛素类似物甘精胰岛素（来得时），此前已被评估为有效、安全且方便。这项前瞻性研究旨在确定甘精胰岛素联合OADs对于先前使用预混胰岛素治疗但控制不佳的2型糖尿病患者是否有效。
在一项开放、对照、随机、平行组、单中心、为期16周的前瞻性研究中，52例2型糖尿病患者（年龄65.6±9.2岁；糖尿病病程15.3±7.6年；胰岛素治疗病程4.2±1.7年，体重指数31.4±2.9kg/m2），糖化血红蛋白（HbA1c）≥8.0%，正在使用预混人胰岛素（75/25或70/30），被随机分为每日一次晨起甘精胰岛素联合格列美脲组（A组；n = 17）、甘精胰岛素联合格列美脲及二甲双胍组（B组；n = 18）或预混胰岛素组（C组；n = 17）。评估血糖控制情况及低血糖发生率。
A组和B组糖化血红蛋白较基线水平显著下降，C组则未下降；（A组：7.87±0.66%，下降0.35%，p = 0.013；B组：7.44±0.92%，下降0.69%，p = 0.0057；C组：7.83±1.13%，下降0.25%，p = 0.32）。终点时，A组、B组和C组之间在糖化血红蛋白、空腹血糖、日均血糖或有症状低血糖方面（平均事件/患者：A组2.2；B组2.3；C组2.0）无治疗差异。终点时，A组88%的患者、B组81%的患者和C组94%的患者选择继续使用其分配的治疗方案。
这项前瞻性研究是首个表明从预混胰岛素转换为甘精胰岛素联合OADs治疗可实现相似血糖控制和治疗满意度的研究。这些结果支持有必要在更大规模的临床研究中对长期患有2型糖尿病且先前使用传统预混胰岛素方案血糖控制欠佳的患者进行前瞻性研究。
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