Department of Endocrinology-Diabetology-Nutrition, Jean Verdier Hospital, Paris Nord University, Bondy, France.
Curr Med Res Opin. 2013 Jun;29(6):601-9. doi: 10.1185/03007995.2013.786692. Epub 2013 Apr 12.
Early initiation of insulin therapy has widely been associated with numerous benefits, including improved glycaemic control and reduced long-term risk of developing microvascular diseases. Biphasic insulins offer a convenient option for insulin initiation, addressing both basal and postprandial insulin requirements with one injection, making them relatively simple for patients to dose. Development of biphasic insulin aspart (BIAsp) has further offered improved postprandial glycaemic control and lower rates of nocturnal and major hypoglycaemia than biphasic human insulin.
The safety and efficacy of the 30/70 rapid-acting/intermediate-acting formulation of BIAsp (BIAsp 30) in patients with type 2 diabetes was examined in the IMPROVE study, a 26-week, international, observational trial. In this subanalysis, baseline clinical factors that predicted treatment success, defined as HbA1c <7% (<53 mmol/mol) without experiencing hypoglycaemia after 26 weeks on BIAsp 30 therapy, were assessed.
The composite endpoint was defined for 44,010 (77%) patients from the total cohort of 57,478, and 28,696 of these were included in the statistical examination. The results of the analysis suggest that those with lower baseline HbA1c of ≤8% (≤64 mmol/mol), shorter duration of diabetes at baseline (<5 years) and no incidence of major hypoglycaemia at 13 weeks, or minor hypoglycaemia at 4 weeks, before the beginning of the trial were more likely to achieve treatment success.
Lower baseline HbA1c, shorter duration of diabetes and no incidence of hypoglycaemia up to 13 weeks prior to initiation are predictors of achieving HbA1c <7% without hypoglycaemia with a BIAsp 30 regimen. These results suggest that it is easier to reach target without hypoglycaemia with BIAsp 30 when prescribed earlier. As this was an observational study, lack of control groups or randomisation, as well as varying clinical practices in study countries, potentially introduced bias.
ClinicalTrials.gov NCT00659282.
早期起始胰岛素治疗与许多益处广泛相关，包括改善血糖控制和降低微血管疾病的长期风险。双相胰岛素提供了一种方便的起始胰岛素的选择，通过一次注射满足基础和餐后胰岛素的需求，使患者相对容易进行剂量调整。双相门冬胰岛素（BIAsp）的开发进一步提供了改善餐后血糖控制和降低夜间和主要低血糖发生率的效果，优于双相人胰岛素。
在一项 26 周的国际观察性试验 IMPROVE 研究中，检查了 2 型糖尿病患者使用 30/70 速效/中效制剂 BIAsp（BIAsp 30）的安全性和疗效。在这项亚分析中，评估了预测治疗成功的基线临床因素，治疗成功定义为在接受 BIAsp 30 治疗 26 周后，HbA1c<7%（<53mmol/mol）且无低血糖发生。
根据总队列 57478 例中的 44010 例（77%）患者定义了复合终点，其中 28696 例患者纳入了统计分析。分析结果表明，那些基线 HbA1c 较低（≤8%[≤64mmol/mol]）、基线糖尿病病程较短（<5 年）、试验开始前 13 周无重大低血糖发作或 4 周内无轻度低血糖发作的患者，更有可能实现治疗成功。
较低的基线 HbA1c、较短的糖尿病病程以及在开始使用 BIAsp 30 方案之前 13 周内无低血糖发生，是实现 HbA1c<7%且无低血糖的预测因素。这些结果表明，当更早地开具 BIAsp 30 处方时，达到无低血糖的目标更容易。由于这是一项观察性研究，缺乏对照组或随机分组，以及研究国家的临床实践存在差异，可能引入了偏倚。
ClinicalTrials.gov NCT00659282。
