随机、开放、低精蛋白锌胰岛素注射液平行对照,联合控释格列吡嗪评价重组甘精胰岛素注射液治疗口服降糖药控制不佳的2型糖尿病患者的有效性和安全性

目的:评价甘精胰岛素与控释格列吡嗪(瑞易宁)联合应用治疗2型糖尿病患者的有效性和安全性。方法:采用随机、开放、低精蛋白锌胰岛素注射液(诺和灵N)平行对照和多中心临床研究方法,对471例服用口服降糖药(OHA)至少3个月而血糖控制不佳(FBG≥7.0mmol_L)的2型糖尿病患者随机进行试验药-甘精胰岛素或对照药-诺和灵N治疗,随访5次共12周。结果:治疗12周时,甘精胰岛素组与诺和灵N组的胰岛素平均每天用量分别为19.21单位和18.68单位,平均空腹血糖分别从入选时10.63mmol_L和10.88mmol_L降至6.96mmol_L和7.20mmol_L,HbA1c分别下降了0.96%和1.25%。甘精胰岛素组和诺和灵N组分别有21.25%(75_353)和28.81%(34_118)的受试者发生低血糖(P=0.0919),其中发生夜间低血糖的受试者分别占9.07%(32_353)和16.10%(19_118)(P=0.0334)。以低血糖的发生例次作为观察指标时,甘精胰岛素组和诺和灵N组分别有174例次和75例次,其中夜间低血糖分别有54例次和44例次,两组均没有严重低血糖事件。结论:12周的临床观察显示,睡前注射一次甘精胰岛素和清晨口服5mg瑞易宁联合应用的治疗方法可使单纯使用口服降糖药而代谢控制不佳的2型糖尿病患者得到良好的血糖控制;以HbA1c和空腹血糖水平作为判断指标,甘精胰岛素和诺和灵N分别与瑞易宁联合应用两种治疗方法对2型糖尿病患者治疗效果相当,但前者夜间低血糖事件发生率低;同时,甘精胰岛素(睡前1次)与瑞易宁联合应用的治疗方法具有良好的耐受性。

A multicenter,randomized,open-labelled,NPH parallel controlled study to evaluate the efficacy and safety of once daily injection of glargine combined with glipizide GITS in the treatment of poor-controled type Ⅱ diabetes mellitus

Objective:To investigate the efficacy and safety of glipizide GITS combined with bedtime insulin glargine or bedtime neutral protamine Hagedorn(NPH)insulin in patients with type 2 diabetes.Methods:471 cases with inadequate glycemia control by sulfonylurea and/or other oral agents were randomized in two groups(3:1).In the Glarine group,patients were given Clipizide GITS 5 mg every morning and injection of Glargine at bedtime daily,while patients in the NPH group were given Clipizide GITS 5 mg every morning and injection of NPH at bedtime daily.The dosage of insulin was adjusted by FBG level,seeking a target of FBG<6.7mmol/L,and the treatment lasted for 12 weeks and 5 visits.Results:The treatment groups showed similar improvements in HbA1c from baseline to end point,and The mean change in HbA1c from baseline to end point was similar in the insulin glargine group(0.96%)and the NPH group(1.25%).Mean daily glucose profile were similar in the 2 groups.The treatments were associated with similar reductions in fasting glucose levels.Overall, mild symptomatic hypoglycemia was similar in insulin glargine subjects(21.25%)and NPH insulin subjects(28.81%),but the incidence of nocturnal hypoglycemia in the Glargine group was significantly lower than that in the NPH group(P=0.0334). Mean daily dosages of glargine and NPH at the end point were 19.21 IU and 18.68IU,respectively.Conclusion:In patients with type 2 diabetes,once-daily bedtime insulin glargine is as effective as once-daily NPH in improving and maintaining glycemic control when combined with Glipizide GITs.In addition,insulin glargine demonstrates a lower risk of nocturnal hypoglycemia and similar weight gain compared with NPH insulin.