礼来糖尿病新药Peglispro临床III期结果优胜于来得时

礼来糖尿病新药Peglispro临床III期结果优胜于来得时

                               
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发布日期：2014-09-05  来源：RTTNews.com  

美国礼来9月4日宣布，公司新开发的糖尿病药物基础胰岛素Peglispro在两项临床III期研究都优于赛诺菲的甘精胰岛素来得时。该药物可用于I类和II类糖尿病治疗。

                               
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　　礼来公司此次进行的2项临床III期研究分别为78周和52周双盲、随机对照试验。结果全都达成预期目标。数据显示，相比甘精胰岛素，基础胰岛素Peglispro在第26周和第52周能大幅度降低I类糖尿病患者体内的血红蛋白A1c（HbA1c）水平。

　　除此之外，接受基础胰岛素Peglispro患者出现的低血糖几率也要远低于服用甘精胰岛素的患者。Peglispro在临床试验中还能降低患者体重，而甘精胰岛素的患者体重则出现上升。

　　公司表示，申报新药所需的临床试验结果已经准备就绪。公司将会在2015年一季度末之前向美国食品药品监督管理局提交申请。

Lilly's BIL Showed HbA1c Superiority Against Lantus In Phase III Trials

Eli Lilly and Co. ( LLY ) Thursday said that in the IMAGINE-1 and IMAGINE-3 Phase III clinical trials in patients with type 1 diabetes, its basal insulin peglispro or BIL demonstrated a statistically significant lower hemoglobin A1c or HbA1c compared with insulin glargine or Lantus at 26 weeks and 52 weeks, respectively.

Patients in these trials were also taking mealtime insulin. Notably, patients in IMAGINE-1 continued treatment beyond 26 weeks, and the HbA1c superiority for BIL was maintained at 52 and 78 weeks.

The Phase III trials needed for submission are now complete. The trials, in both type 1 and type 2 diabetes, showed consistent superiority of HbA1c for BIL against comparators.

Lilly is on track to file a submission with regulators by the end of the first quarter in 2015.

The primary efficacy endpoint of non-inferior HbA1c at the primary study endpoint compared with insulin glargine was met in both the IMAGINE-1 and IMAGINE-3 trials, and superiority was also shown.

In addition, significantly more patients taking BIL compared to those taking insulin glargine achieved an HbA1c of less than 7 percent, a target for glycemic control established by the American Diabetes Association.

Both trials also showed the rate of nocturnal hypoglycemia was significantly lower in patients taking BIL than in those taking insulin glargine.

Additionally, both trials showed a statistically significant difference in weight. Patients taking BIL experienced weight loss, even with lower HbA1c, compared with weight gain in patients taking insulin glargine.

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