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首页> 外文期刊>BMC Endocrine Disorders >A prospective randomised cross-over study of the effect of insulin analogues and human insulin on the frequency of severe hypoglycaemia in patients with type 1 diabetes and recurrent hypoglycaemia (the HypoAna trial): study rationale and design
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A prospective randomised cross-over study of the effect of insulin analogues and human insulin on the frequency of severe hypoglycaemia in patients with type 1 diabetes and recurrent hypoglycaemia (the HypoAna trial): study rationale and design

机译：胰岛素类似物和人胰岛素对1型糖尿病和复发性低血糖患者严重低血糖发生频率的影响的前瞻性随机交叉研究（HypoAna试验）：研究原理和设计

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Background Severe hypoglycaemia still represents a significant problem in insulin-treated diabetes. Most patients do not experience severe hypoglycaemia often. However, 20% of patients with type 1 diabetes experience recurrent severe hypoglycaemia corresponding to at least two episodes per year. The effect of insulin analogues on glycaemic control has been documented in large trials, while their effect on the frequency of severe hypoglycaemia is less clear, especially in patients with recurrent severe hypoglycaemia. The HypoAna Trial is designed to investigate whether short-acting and long-acting insulin analogues in comparison with human insulin are superior in reducing the occurrence of severe hypoglycaemic episodes in patients with recurrent hypoglycaemia. This paper reports the study design of the HypoAna Trial. Methods/design The study is a Danish two-year investigator-initiated, prospective, randomised, open, blinded endpoint (PROBE), multicentre, cross-over trial investigating the effect of insulin analogues versus human insulin on the frequency of severe hypoglycaemia in subjects with type 1 diabetes. Patients are randomised to treatment with basal-bolus therapy with insulin detemir / insulin aspart or human NPH insulin / human regular insulin in random order. The major inclusion criterion is history of two or more episodes of severe hypoglycaemia in the preceding year. Discussion In contrast to almost all other studies in this field the HypoAna Trial includes only patients with major problems with hypoglycaemia. The HypoAna Trial will elucidate whether basal-bolus regimen with short-acting and long-acting insulin analogues in comparison with human insulin are superior in reducing occurrence of severe hypoglycaemic episodes in hypoglycaemia prone patients with type 1 diabetes. http://www.clinicaltrials.gov webcite : NCT00346996.
机译：背景技术严重的低血糖症仍然代表着胰岛素治疗的糖尿病的重大问题。大多数患者通常不会出现严重的低血糖症。但是，20％的1型糖尿病患者会反复发作严重的低血糖症，每年至少发生两次。胰岛素类似物对血糖控制的作用已在大型试验中得到证实，但它们对严重低血糖发生频率的影响尚不清楚，特别是在复发性严重低血糖患者中。 HypoAna试验旨在研究与人胰岛素相比，短效和长效胰岛素类似物在减少复发性低血糖患者中严重降血糖发作的发生方面是否更优越。本文报告了HypoAna试验的研究设计。方法/设计本研究是丹麦研究人员发起的一项为期两年的前瞻性，随机，开放，盲目的终点（PROBE）多中心交叉试验，研究了胰岛素类似物与人胰岛素对受试者严重低血糖发生率的影响1型糖尿病。患者被随机分配接受以地特胰岛素/门冬胰岛素或人NPH胰岛素/人常规胰岛素的基础推注治疗。主要纳入标准是前一年两次或多次严重低血糖的病史。讨论与该领域几乎所有其他研究相反，HypoAna试验仅包括严重低血糖症患者。 HypoAna试验将阐明与人胰岛素相比，短效和长效胰岛素类似物的基础推注方案在减少易发生低血糖的1型糖尿病患者中严重降血糖事件的发生方面是否更为优越。 http://www.clinicaltrials.gov网站：NCT00346996。

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