ORLANDO (EGMN) –An investigational rapid-acting human insulin formulation provided similar glucose control to regular human insulin but with a twofold reduction in hypoglycemia and significantly less weight gain in a 6-month, multicenter, open-label study of 471 patients with type 2 diabetes.
The insulin formulation, called VIAject(R), is absorbed more rapidly after subcutaneous injection than either insulin lispro or regular human insulin. Findings from Biodel Corp.’s phase III study of VIAject were presented at the annual scientific sessions of the American Diabetes Association by Dr. Helena Rodbard, an endocrinologist in private practice in Rockville, Maryland, and a past president of the American College of Endocrinology and the American Association of Clinical Endocrinologists.
The subjects had a mean age of about 56 years, slightly more than half were male, and the mean body mass index was 33 kg/m2. At baseline, they had a mean hemoglobin A1c value of 8%. They were randomized to either preprandial VIAject or human regular insulin in combination with previously prescribed insulin glargine, metformin, and/or thiazolidinedione therapy. Because of the difference in action time, regular human insulin was injected 30-40 minutes before meals, while VIAject was given immediately before eating.
At 6 months, the mean reduction in A1c was similar in the two groups, with the VIAject group dropping by 0.56 percentage points and the regular human insulin group by 0.70 points. But nonsevere hypoglycemic event rates were significantly reduced in the patients taking VIAject, at just 0.33 events/month, compared with 0.66 events/month with regular human insulin, Dr. Rodbard reported.
Patients taking VIAject also gained significantly less weight, an average of 0.46 kg vs. 1.35 kg with regular human insulin.
Insulin antibody levels and other laboratory tests monitoring safety were similar for both groups. Injection site pain or irritation was greater with VIAject, but this declined during the course of the study. Moreover, the proposed U-100 pH-neutral commercial formulation of VIAject is associated with less injection site discomfort than the U-25 pH 4 version used in this study, she pointed out.
Biodel is seeking U.S. Food and Drug Administration clearance to market VIAject(R) based on two pivotal 6-month phase III clinical trials in patients with type 1 and type 2 diabetes, as well as results from long-term, 18-month safety extension trials for patients who completed the two pivotal phase III clinical trials. The Prescription Drug User Fee Act action date for Biodel’s new drug application is expected to be Oct. 30, 2010, the company said in a statement.
In addition to receiving research grant support from Biodel and serving on the company’s advisory board, Dr. Rodbard also has received consultant honoraria, speaker honoraria, and/or research grant support from Abbott Laboratories, AstraZeneca Pharmaceuticals, Biodel, GlaxoSmithKline, MannKind, Merck, Novo Nordisk, Sanofi-Aventis US, Takeda Pharmaceuticals North America, Amylin Pharmaceuticals, Bristol-Myers Squibb Co., Eli Lilly, and MacroGenics.
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奥兰多(EGMN)—— 一项在471例2型糖尿病患者中开展的6个月、多中心、开放性试验表明，一种在研速效人胰岛素制剂所产生的血糖控制效果与常规人胰岛素相似，但低血糖事件的发生率却减少了一半，并且体重增幅也显著缩小。
这种名为VIAject (R)的胰岛素制剂经皮下注射后可被人体迅速吸收，其吸收速度快于赖脯胰岛素或常规人胰岛素。美国内分泌学院和美国临床内分泌学家协会前任主席，现为马里兰州洛克威尔一家私人诊所的内分泌科医生Helena Rodbard 博士在美国糖尿病学会2010年科学年会上报告了Biodel公司主办的VIAject III期试验的结果。
受试者的平均年龄约为56岁，男性占一半多一点，平均体重指数为33 kg/m2。基线时，受试者的平均血红蛋白A1c测值为8%。将受试者随机分组，分别在其原有甘精胰岛素、二甲双胍和(或)噻唑烷二酮类药物的基础上加用餐前VIAject或人常规胰岛素。由于作用时间有所不同，因此常规人胰岛素是在餐前30~40 min注射，而VIAject则是在用餐前即刻注射。
Rodbard 博士报告称，第6个月时两组患者的A1c平均下降幅度相似，VIAject组下降了0.56个百分点，常规人胰岛素组下降了0.70个百分点。但VIAject组患者的非重度低血糖事件的发生率显著降低，仅为0.33例事件/月，而常规人胰岛素组为0.66例事件/月。
VIAject组患者的体重增幅也显著缩小，仅平均增加了0.46 kg，而常规人胰岛素组增加了1.35 kg。
两组患者的胰岛素抗体水平以及监测药物安全性的其他实验室检查的结果均相似。在VIAject组中，注射部位疼痛或刺激更明显，但随着试验的开展这种情况逐渐减少。Rodbard 博士指出，而且，VIAject上市后将采用的U-100 pH中性制剂所产生的注射部位不适感会低于该试验所采用的VIAject U-25 pH 4制剂。
Biodel目前正基于两项在1型糖尿病和2型糖尿病患者中开展的为期6个月的关键性III期临床试验以及在完成了这两项关键性III期临床试验的患者中开展的长期、18个月安全性拓展试验的结果，向美国食品药品管理局提出VIAject(R)的上市申请。Biodel在一份声明中表示，预计Biodel新药上市申请的处方药使用者手续费规定的执行日期为2010年10月30日。
Rodbard 博士声明接受了Biodel公司提供的研究经费，也是该公司顾问委员会成员。此外，还接受了雅培实验室、阿斯利康制药公司、Biodel、葛兰素史克、MannKind、默克、诺和诺德、赛诺菲-安万特美国公司、武田制药北美公司、Amylin制药公司、百时美-施贵宝、礼来以及MacroGenics公司提供的咨询费、讲课费和(或)研究经费。
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