A study comparing insulin lispro mix 25 with glargine plus lispro therapy in patients with Type 2 diabetes who have inadequate glycaemic control on oral anti-hyperglycaemic medication: results of the PARADIGM study
A study comparing insulin lispro mix 25 with glargine plus lispro therapy in patients with Type 2 diabetes who have inadequate glycaemic control on oral anti-hyperglycaemic medication: results of the PARADIGM study
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DOI：
10.1111/j.1464-5491.2012.03722.x
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发表时间：
2012-09-01
影响因子：
3.5
通讯作者：
Oliveira, J.
中科院分区：
文献类型：
--
作者：
Bowering, K.;Reed, V. A.;Oliveira, J.
迪亚贝特。地中海医院。29，e263-e272(2012)摘要目的是验证这样一种假设，即在糖化血红蛋白基础上，25%赖斯普罗胰岛素和75%赖斯普罗胰岛素鱼精蛋白混悬液(LM25)启动和强化治疗不逊于甘精+赖斯普利胰岛素启动和强化治疗。方法在这项随机、非劣势(边际为0.4%)、平行、前瞻性、多国家、为期48周的开放研究中，426名口服降糖药物未能得到充分控制的2型糖尿病患者被分成两组，一组开始治疗，每天注射一次LM25，进展到每天三次注射(完全分析组n=211；按照方案组n=177)；或者开始治疗，每天注射一次甘精精，并进展到每天三次胰岛素lispros注射(完全分析组n=212，每组方案n=184)。结果研究结束时，LM25治疗效果不逊于甘精+赖斯普利治疗(上限为95%CI和0.4)，HbA1c(LM25减去甘精+赖普利)的最小二乘均值差(95%CI)为-0.4 mmol/mol(95%CI-2.7~1.9)；-0.04%(95%CI-0.25~0.17)。在达到HbA1c目标的患者百分比或餐后血糖水平方面，治疗组之间没有发现显著的统计学差异。两组在研究过程中胰岛素剂量、注射次数和体重变化的增加是相似的。两组患者的低血糖发生率和安全性相似。结论对于口服降糖药物控制不佳的2型糖尿病患者，LM25开始和强化治疗时的血糖控制效果不亚于甘精+赖斯普利治疗。
Diabet. Med. 29, e263-e272 (2012) Abstract Aims To test the hypothesis that initiation and intensification with 25% insulin lispro, 75% insulin lispro protamine suspension (LM25), is non-inferior to initiation and intensification with glargine + insulin lispro therapy on change from baseline in HbA1c. Methods In this randomized, non-inferiority (margin of 0.4%), parallel, prospective, multi-country, 48-week, open-label study, patients (n = 426) with Type 2 diabetes inadequately controlled with oral anti-hyperglycaemic medications were assigned to either initiating therapy with one daily LM25 injection, progressing up to three daily injections (full analysis set n = 211; per protocol set n = 177) or initiating therapy with one daily glargine injection and progressing up to three daily insulin lispro injections (full analysis set n = 212; per protocol set n = 184). Results LM25 therapy was found to be non-inferior to glargine + insulin lispro therapy by study end (upper limit of 95% CI < 0.4), with a least-squares mean difference (95% CI) in HbA1c (LM25 minus glargine + insulin lispro) of -0.4 mmol/mol (95% CI -2.7 to 1.9); -0.04% (95% CI -0.25 to 0.17). No statistically significant differences between treatment groups were found in the percentage of patients achieving HbA1c targets or postprandial blood glucose levels. The increase in insulin dose, number of injections and weight change during the course of the study were similar in both groups. Patients in both groups experienced similar hypoglycaemia rates and safety profile. Conclusions For patients with Type 2 diabetes inadequately controlled with oral anti-hyperglycaemic medications, glycaemic control when initiating and intensifying with LM25 therapy was found to be non-inferior to treatment with glargine + insulin lispro therapy.