赛诺菲新数据支持Lyxumia给药时间的灵活性

赛诺菲（Sanofi）12月5日宣布，有关降糖药Lyxumia（lixisenatide）的一项IIIb期研究达到了非劣性的主要终点。该项研究为期24周，在451例经二甲双胍单药治疗未能良好控制的2型糖尿病患者中开展，研究中，患者随机分组接受主餐前或早餐前接受Lyxumia治疗。午餐（经询问患者确定）是53%的患者一天中的主餐。

研究的主要终点是，证明主餐前注射 vs 早餐前注射Lyxumia，在24周时糖化血红蛋白（HbA1c）从基线水平下降的非劣效性。

研究结果表明，主餐前注射Lyxumia和早餐前注射Lyxumia分别使HbA1c平均下降了0.65%和0.74%，达到了非劣效性主要终点。此外，主餐组和早餐组患者分别有43.6%和42.8%的患者HbA1c水平低于7%，体重平均变化分别为2.6公斤和2.8公斤，2组患者胃肠道耐受性相当，低血糖发生率均很低，无重症病例。

这些结果表明，Lyxumia在2个时间点（主餐前和早餐前）给药均能够有效降低血糖。

关于Lyxumia：

Lyxumia是一种胰高血糖素样肽1受体激动剂（GLP-1 RA），用于2型糖尿病患者的治疗。GLP-1是一种自然产生的肽类激素，在餐后的几分钟内被释放，能够抑制胰岛α细胞分泌胰高血糖素，并刺激胰腺β细胞的葡萄糖依赖性胰岛素分泌。

目前，Lyxumia已获欧盟批准，与口服降糖药或基础胰岛素联合用药，并结合饮食及运动，用于2型糖尿病患者的血糖控制。

英文原文：New Data Support Flexibility in Timing of Administration for Sanofi's Lyxumia®

- Similar glucose lowering effect when once-daily Lyxumia is administered before breakfast or the main meal -

PARIS , Dec. 5, 2013 /CNW/ - Sanofi (EURONEXT : SAN and NYSE : SNY) announced today the results of a 24-week Phase IIIb clinical study showing that Lyxumia® (lixisenatide) met the primary endpoint of non-inferiority in blood sugar lowering (HbA1c) when administered either before breakfast or the main meal of the day. These results indicate that lixisenatide can effectively lower blood sugar at either time of administration.

"Helping patients reach their HbA1c goal is the main objective of type 2 diabetes treatment," said Professor Bo Ahren , Faculty of Medicine, Lund University, Sweden . "Flexibility in timing of administration is also an important attribute, especially for injectable diabetes therapies. This study shows that once-daily lixisenatide meets these criteria, which is significant for an agent that is prescribed for use in combination with existing treatment regimens."

The results also showed that a comparable reduction in body weight, regardless of the meal before which lixisenatide was administered, was achieved. In addition, gastrointestinal tolerability was comparable regardless of time of administration, with no cases of severe hypoglycemia in either arm. The data were shared during an oral presentation at the World Diabetes Congress 2013 in Melbourne, Australia .

Results of Analysis

The 24-week Phase IIIb study examined 451 patients with type 2 diabetes, uncontrolled on metformin alone, randomized to lixisenatide either prior to the main meal or prior to breakfast. Lunch (as defined by questioning patients) was the main meal of the day for 53% of patients.

The primary endpoint of the study, demonstrating non-inferiority in HbA1c decrease at 24 weeks from baseline when lixisenatide was injected prior to the main meal of the day vs. breakfast, was successfully achieved with mean HbA1c reductions of 0.65% and 0.74% respectively. In addition, 43.6% of patients in the main meal group and 42.8% in the breakfast group achieved HbA1c below 7%. The mean change in body weight was -2.6kg in the main meal group and -2.8kg in the breakfast group. Gastrointestinal tolerability was comparable between the two groups (nausea 14.7% and 15.5% and vomiting 2.7% and 3.5%, respectively) and the incidence of symptomatic hypoglycemia was low in both groups, with no severe cases.

This study abstract is entitled: 'Flexibility in timing of lixisenatide administration prior to either the main meal of the day or the breakfast in T2DM patients' (Ahren B, et al. Oral presentation December 5, 2013 , 10:45−12:45 [ABS OP-0454]).

About Lyxumia® (lixisenatide)

Lyxumia® (lixisenatide) is a once-daily prandial glucagon-like peptide-1 receptor agonist (GLP-1 RA) for the treatment of patients with type 2 diabetes mellitus. GLP-1 is a naturally-occurring peptide hormone that is released within minutes after eating a meal. It is known to suppress glucagon secretion from pancreatic alpha cells and stimulate glucose-dependent insulin secretion by pancreatic beta cells.

Lyxumia was in-licensed from Zealand Pharma A/S , and is approved in Europe for the treatment of adults with type 2 diabetes mellitus to achieve glycemic control in combination with oral glucose-lowering medicinal products and/or basal insulin when these, together with diet and exercise, do not provide adequate glycemic control. Lyxumia is also approved in Mexico , Australia , Japan , Brazil , Colombia and Chile for the treatment of adults with type 2 diabetes. Sanofi plans to resubmit the New Drug Application for lixisenatide in the United States in 2015, after completion of the ELIXA cardiovascular outcomes study. Lyxumia is the proprietary name approved by the European Medicines Agency and other health authorities for the GLP-1 RA lixisenatide.

The Lyxumia pen is the winner of a number of innovative design awards, including the Good Design Award 2012 and the iF Product Design Award. The variant of the Lyxumia pen used in Japan won the Good Design Award (G Mark) 2013.

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