Lilly's ultra rapid lispro provided similar A1C reductions compared to Humalog® , with superior post-meal blood glucose reductions

礼来公司超速效胰岛素URLi疗效媲美Humalog,餐后血糖控制效果更优

2019-06-09 23:30:00 PR Newswire

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Two phase 3 studies show that Eli Lilly and Company's (LLY) ultra rapid lispro (URLi) provided non-inferior A1C reductions compared to Humalog® (insulin lispro) at 26 weeks in people with type 1 and type 2 diabetes. The data from these treat-to-target studies showed URLi also significantly reduced the rise in blood glucose one hour and two hours after a test meal compared to Humalog.1,2 Additional data from the study in people with type 1 diabetes demonstrated URLi significantly improved glucose time in range during the day.3 URLi is an investigational novel mealtime insulin formulation being developed to better manage blood glucose levels. These data and several other studies were presented at the American Diabetes Association's® 79th Scientific Sessions®.  The two phase 3 studies, PRONTO-T1D and PRONTO-T2D, evaluated the safety and efficacy of URLi compared to Humalog in adults with type 1 and type 2 diabetes, respectively. Both studies met the primary endpoint of non-inferior A1C reduction from baseline compared to Humalog at 26 weeks, when the insulins were dosed at mealtime. Further, URLi demonstrated superior reduction in blood glucose spikes at both one hour (-27.9 mg/dL [T1D], -11.8 mg/dL [T2D]) and two hours (-31.2 mg/dL [T1D] and -17.4 mg/dL [T2D]) after a test meal compared to Humalog.1,2 Hypoglycemia is the most common adverse reaction associated with insulin. The studies showed no significant difference in severe, nocturnal or overall hypoglycemia rates reported by study participants.1,2 "Many people taking mealtime insulin are not meeting their A1C goals while also experiencing high blood glucose levels after eating. This may create worry about their ability to achieve good control," said Bruce Bode, MD, FACE, diabetes specialist at Atlanta Diabetes Associates.4 "The results from these two studies suggest that URLi may help control blood glucose after meals, as well as help people reach A1C goals." The PRONTO studies were designed as treat-to-target, which enables clinicians to determine differences in other important treatment effects – such as rates of hypoglycemia, post-meal glucose control and glucose time in range – at the same level of glycemic control. A sub-set of participants in PRONTO-T1D were evaluated using blinded continuous glucose monitoring to provide more complete information on daily blood glucose patterns. At 26 weeks, URLi demonstrated a significantly better blood glucose profile up to four hours after breakfast compared to Humalog. The study further showed that URLi had significantly longer (+43.6 minutes) time in range (71-180 mg/dL) during the day and similar time in range during the night compared to Humalog.3  Data from a phase 1 clinical pharmacology study in people with type 1 diabetes also demonstrated URLi's effect on post-meal blood glucose control. Results showed URLi was absorbed significantly faster into the blood stream compared to Humalog, insulin aspart and fast-acting insulin aspart. URLi also showed lower blood glucose spikes after a test meal compared to the insulins tested, which was significant compared to Humalog and insulin aspart. Additionally, the early blood glucose profile with URLi closely matched that of participants without diabetes.5 "We're developing URLi to provide a mealtime insulin option that more closely mirrors the way insulin works in people without diabetes," said Tom Hardy, MD, PhD, senior medical director at Lilly. "If approved, URLi will offer a new mealtime insulin option that, in clinical trials, showed similar A1C reductions to Humalog with significant improvements in post-meal blood glucose after a test meal." Lilly submitted applications for URLi with regulatory authorities in Europe and Japan and plans to submit in the U.S. later this year.
两个阶段3的研究表明,礼来(Eli Lilly)和 Company ( LLY )超快速赖脯( URLi )在1型和2型糖尿病患者中,与 Humulog ®(胰岛素赖脯)在26周时相比,提供了非劣质的 A1C 降低。这些以治疗为目标的研究数据显示, URLi 与 Humalog 相比,在试餐一小时两小时后显著降低了血糖的升高。1,2来自1型糖尿病患者研究的额外数据显示, URLi 显著改善了白天的血糖时间范围。3 URLi 是一种研究新型的肉类胰岛素制剂,正在开发中,以更好地管理血糖水平。这些数据和其他几项研究发表在美国糖尿病协会的第79届科学会议上。 这两个第三阶段的研究,即 PRONTO-T1D 和 PRONTO-T2D ,分别评估了 URLi 相对于1型和2型糖尿病患者的安全性和有效性。这两项研究都达到了非劣质 A1C 降低的主要终点,与26周时的 Humanlog 相比,当时在吃饭时间服用胰岛素。此外,与 Humalog 相比, URLi 在一顿试餐后1小时(-27.9 mg / dL [ T1D ]、-11.8 mg / dL [ T2D ])和2小时(-31.2 mg / dL [ T1D ]和-17.4 mg / dL [ T2D ])的血糖峰值均有显著降低。1,2 低血糖是最常见的与胰岛素相关的不良反应。研究显示,研究参与者报告的严重、夜间或整体低血糖发生率没有显著差异。1,2 “许多人吃肉时胰岛素不能达到他们的 A1C 目标,同时也经历了高血糖后吃。亚特兰大糖尿病协会糖尿病专家 BruceBode 医学博士说:“这可能会引起人们对他们实现良好控制的能力的担忧。”“这两项研究的结果表明, URLi 可能有助于控制饭后的血糖,并帮助人们达到 A1C 的目标。” PRONTO 研究设计为以治疗为目标,使临床医生能够在血糖控制水平相同的情况下,确定其他重要治疗效果的差异——如低血糖率、餐后血糖控制和血糖范围内的时间。对一组参与 PRONTO-T1D 的人进行了评估,采用盲持续性血糖监测,以提供关于每日血糖模式的更完整信息。在26周时,与 Humalog 相比, URLi 显示早餐后4小时血糖状况明显好于 Humalog 。研究进一步表明, URLi 白天的范围(71-180 mg / dL )时间明显长(+43.6分钟),夜间的范围与 Humanlog 相似。3. 来自1型糖尿病患者1期临床药理研究的数据也显示了 URLi 对餐后血糖控制的影响。结果显示,与人源学、门冬胰岛素和快速作用的门冬胰岛素相比, URLi 在血液中的吸收速度要快得多。与检测的胰岛素相比, URLi 检测餐后血糖峰值也较低,这与人源学和门冬胰岛素相比具有显著性意义。此外,早期血糖与尿嘧啶密切匹配的参与者没有糖尿病。5、5 “我们正在开发 URLi ,以提供一种肉类胰岛素选择,更密切地反映胰岛素在糖尿病患者中的作用,”汤姆·哈迪博士说,医学博士,礼来(Lilly)公司的高级医学主任。如果获得批准, URLi 将提供一种新的肉类胰岛素选择,在临床试验中,在餐后血糖明显改善的情况下,该选择与 Humanlog 的 A1C 降低相似。 礼来(Lilly)向欧洲和日本的监管机构提交了 URLi 的申请,并计划今年晚些时候在美国提交。

以上中文文本为机器翻译,存在不同程度偏差和错误,请理解并参考英文原文阅读。

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