EFFICACY OF EARLY GLARGINE PLUS STANDARD IV INSULIN VERSUS STANDARD IV INSULIN IN PATIENTS WITH DIABETIC KETOACIDOSIS: A RANDOMISED CONTROLLED TRIAL - NIL

开始日期2024-09-30

申办/合作机构-

NCT06340854 / Recruiting临床3期

A Study to Evaluate the Efficacy and Safety of Once-weekly Insulin Icodec When Switching From Daily Basal Insulins Compared to Once-daily Insulin Glargine U100 in Adults With Type 2 Diabetes

This study compares insulin icodec, a new insulin taken once a week, to insulin glargine, an insulin taken once a day. The study medicine will be investigated in participants with type 2 diabetes. Participants will either get insulin icodec or insulin glargine. Which treatment participants get is decided by chance. Insulin icodec is the new medicine being tested, while insulin glargine is already approved and can be prescribed by doctors. Participants will get one injection of insulin icodec once a week, or one injection of insulin glargine once a day, depending on the treatment group participants are assigned into. Participants will use a pen with a small needle to inject the medicine under participants skin into participants thigh, upper arm or stomach.The study will last for about 9 months, but participants will only be taking the study medicine for 6 months.

开始日期2024-04-19

申办/合作机构

Novo Nordisk A/S

NCT06619301 / Recruiting临床3期IIT

Randomized Controlled Trial of Glargine Versus Neutral Protamine Hagedorn Insulin for the Treatment of Diabetes Mellitus in Pregnancy

We are asking you to take part in this research study because you are diagnosed with pregestational Type 2 Diabetes Mellitus or Gestational Diabetes Mellitus requiring insulin therapy in pregnancy. Currently, many hospitals differ among use of insulin for management of DM in pregnancy, with NPH, glargine and detemir being the most commonly used forms of basal insulin. Outside of pregnancy, NPH is rarely used with glargine and determir being the more common forms of insulin used due to their fewer episodes of hypoglycemia in these patients. Detemir has been well studied in pregnancy and found to be noninferior to NPH. Unfortunately, glargine has not been as well studied in pregnancy. Thus, with this study we want to compare glargine and NPH.
The purpose of this study is to compare two different forms of insulin (Glargine and NPH) that we regularly use to manage diabetes mellitus in pregnancy.

开始日期2024-04-01

申办/合作机构

Loyola University Medical Center

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100 项与甘精胰岛素相关的专利（医药）

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2,111

项与甘精胰岛素相关的文献（医药）

2024-12-01·Diabetes, Obesity and Metabolism

Efficacy and safety of once‐weekly insulin icodec versus once‐daily basal insulin in Japanese individuals with type 2 diabetes: A subgroup analysis of the ONWARDS 1, 2 and 4 trials

Article

作者: Nishimura, Rimei ; Ásbjörnsdóttir, Björg ; Nishida, Tomoyuki ; Yamamoto, Yuiko ; Kadowaki, Takashi ; Yamauchi, Toshimasa ; Watada, Hirotaka

AbstractAimTo explore the efficacy and safety of once‐weekly insulin icodec (icodec) in Japanese adults (≥20 years old) with type 2 diabetes from the global ONWARDS 1, 2 and 4 trials.Materials and MethodsInsulin‐naive (ONWARDS 1) and insulin‐experienced (ONWARDS 2 and 4) individuals were randomized to icodec or a once‐daily insulin comparator: insulin glargine U100 [ONWARDS 1 (basal insulin only) and 4 (basal–bolus regimen)] or insulin degludec [ONWARDS 2 (basal insulin only)]. The primary outcome was change in glycated haemoglobin from baseline to end of treatment (EOT) (ONWARDS 1: Week 52; ONWARDS 2 and 4: Week 26). Here, we present the Japanese subgroup results.ResultsSimilar reductions in glycated haemoglobin from baseline to EOT were observed in each trial for icodec and comparators. The proportion of time in range (blood glucose 3.9–10.0 mmol/L) at EOT was also comparable across treatment groups (time in range: 58%–68%), as was time spent with blood glucose below 3.0 mmol/L (<1.0%). Combined clinically significant (blood glucose <3.0 mmol/L) or severe (requiring external assistance for recovery) hypoglycaemia rates were low, with no severe events (ONWARDS 1 and 2) or a single severe event (ONWARDS 4; icodec group) reported. These results generally aligned with findings from the respective global populations. No new safety issues were identified.ConclusionsIcodec improved glycaemic control to a similar degree as once‐daily basal insulin comparators while maintaining low levels of clinically significant or severe hypoglycaemia. The findings support icodec use in Japanese individuals with different levels of type 2 diabetes progression.

2024-11-01·Diabetes Research and Clinical Practice

A post-hoc pooled analysis to evaluate efficacy and safety of insulin glargine 300 U/mL in insulin-naïve people with type 2 diabetes with/without prior use of glucagon-like peptide-1 receptor agonist therapy

Article

作者: Al-Sofiani, Mohammed E. ; Ritzel, Robert ; Cheng, Alice Y.Y. ; Mimouni, Safia ; Cheng, Alice Y Y ; Bailey, Timothy ; Bonnemaire, Mireille ; Melas-Melt, Lydie ; Aileen Mabunay, Maria ; Al-Sofiani, Mohammed E ; Mauricio, Didac ; Davies, Melanie

AIMSTo evaluate treatment advancement with insulin glargine 300 U/mL (Gla-300), with or without prior glucagon-like peptide-1 receptor agonist (GLP-1 RA) therapy in type 2 diabetes (T2D).METHODSEfficacy and safety outcomes of insulin-naïve patients intensifying with Gla-300, with/without prior GLP-1 RA therapy, were evaluated in three analyses (N = 3562): a pooled analysis of seven interventional studies, a subanalysis comparing participants who stopped GLP-1 RA therapy and initiated Gla-300 with those who received add-on Gla-300, and an expanded analysis including two observational studies.RESULTSGlycaemic outcomes, including HbA1c improvement and fasting plasma glucose, were similar between groups with/without prior GLP-1 RA use. HbA1c least squares mean change from baseline was - 1.7 % and - 1.6 % with and without prior GLP-1 RA, respectively. Glycaemic outcomes were similar between participants who stopped GLP-1 RA therapy when initiating Gla-300 and those who received add-on Gla-300, although more participants receiving add-on Gla-300 achieved HbA1c targets. The expanded analysis yielded similar results. Incidence of hypoglycaemia was low with no clinically relevant weight changes in all analyses.CONCLUSIONSTreatment advancement with Gla-300 in patients with T2D, with/without prior GLP-1 RA therapy, improved glycaemic outcomes with no relevant impact on weight, while maintaining a low hypoglycaemia risk.

2024-11-01·The Lancet Diabetes & Endocrinology

Continuous glucose monitoring-based metrics and the duration of hypoglycaemia events with once-weekly insulin icodec versus once-daily insulin glargine U100 in insulin-naive type 2 diabetes: an exploratory analysis of ONWARDS 1

Article

作者: Ásbjörnsdóttir, Björg ; Mader, Julia K ; Nishida, Tomoyuki ; Lingvay, Ildiko ; Bergenstal, Richard M ; Watt, Sara K ; Rosenstock, Julio

BACKGROUNDContinuous glucose monitoring (CGM) can provide a comprehensive assessment of glycaemic control. This exploratory analysis of the ONWARDS 1 trial assessed CGM-based metrics and CGM-derived hypoglycaemia duration in insulin-naive individuals with type 2 diabetes treated with subcutaneous once-weekly insulin icodec (icodec) versus once-daily insulin glargine U100 (glargine U100).METHODSONWARDS 1 was a 78-week (52-week main treatment phase and a 26-week treatment extension phase plus a 5-week follow-up), randomised, open-label, treat-to-target, phase 3a trial done at 143 sites (outpatient clinics and hospital departments) across 12 countries. Adults (aged ≥18 years) with type 2 diabetes (HbA_1c: 7·0-11·0%) who had not previously received insulin were randomly assigned (1:1) via an interactive web-response system to once-weekly icodec or once-daily glargine U100. Double-masked CGM data were collected during treatment initiation (weeks 0-4), midtrial (weeks 22-26), end of main phase (weeks 48-52), end of extension phase (weeks 74-78), and follow-up (weeks 78-83). Secondary and exploratory outcomes were CGM-based metrics, including the mean percentages of time in glycaemic range (TIR; sensor glucose 3·9-10·0 mmol/L [70-180 mg/dL]), time in tight range (TITR; 3·9-7·8 mmol/L [70-140 mg/dL]), time above range (TAR; >10·0 mmol/L [>180 mg/dL]), and time below range (TBR; <3·9 mmol/L [<70 mg/dL] and <3·0 mmol/L [<54 mg/dL]), and CGM-derived hypoglycaemic episode durations (episodes defined by sensor glucose <3·9 mmol/L [<70 mg/dL for ≥15 consecutive minutes]). Analyses were done in the full analysis set (all randomly assigned participants). The ONWARDS 1 trial is registered with ClinicalTrials.gov, NCT04460885, and is complete.FINDINGSParticipants were enrolled and randomly assigned in ONWARDS 1 between Nov 25, 2020, and Dec 1, 2022 (n=492 in each treatment group). During treatment initiation, we observed no statistically significant differences in the mean percentages of TIR, TITR, TAR, and TBR with icodec versus glargine U100. During the midtrial, end of main phase, and end of extension phase periods, the mean percentages of TIR and TITR were statistically significantly greater and the mean percentages of TAR statistically significantly lower with icodec versus glargine U100. The mean percentages of TIR met the internationally recommended CGM target (>70%) with icodec but not with glargine U100 during the three periods. TBR (<3·9 mmol/L [<70 mg/dL] and <3·0 mmol/L [<54 mg/dL]) was low and below recommended targets (<4% and <1%, respectively) across all study periods in both treatment groups, with no statistically significant differences between treatment groups for the lower threshold (<3·0 mmol/L [<54 mg/dL]). During the follow-up period, mean percentages of TIR, TITR, TAR, and TBR did not statistically significantly differ with icodec versus glargine U100. The duration of overall hypoglycaemic episodes was similar between treatment groups throughout the trial (median duration ≤35 min).INTERPRETATIONThese CGM data support the long-term efficacy and safety of icodec versus glargine U100 during treatment and indicated no increase in the duration of individual hypoglycaemic episodes with icodec versus glargine U100 in insulin-naive individuals with type 2 diabetes.FUNDINGNovo Nordisk.

312

项与甘精胰岛素相关的新闻（医药）

2024-11-19

·国际糖尿病idiabetes

中国INITIATION研究亮相ATTD-ASIA，甘精胰岛素U300显著改善dTIRs，成为升级优选！

点击“蓝字”关注我们编者按 11月18日第1届亚洲糖尿病管理创新疗法大会（ATTD-ASIA 2024）在新加坡盛大启幕，汇聚了全球内分泌领域专家学者与行业翘楚，共同探讨糖尿病领域的最新科研成果与临床进展。其中，基础胰岛素治疗领域有多项研究发布，成为备受瞩目的焦点。作为新一代超长效基础胰岛素类似物，甘精胰岛素U300因控糖疗效更持久更平稳、低血糖风险更低，成为糖尿病患者胰岛素治疗的优选方案之一[1-4]。在贴近真实世界医疗实践的环境下，甘精胰岛素U300在中国2型糖尿病（T2DM）人群中的临床应用效果获得验证：2023年，天津医科大学朱宪彝纪念医院陈莉明教授牵头开展的中国INITIATION研究及亚组分析首次发布在IDF大会上，为胰岛素初治以及从其他基础胰岛素转换的血糖控制不佳的中国T2DM患者人群，起始甘精胰岛素U300治疗提供了坚实的循证[5-6]。该研究的事后分析及亚组分析成果[7-8]于本次大会隆重揭晓，进一步提供了甘精胰岛素U300在衍生葡萄糖目标范围内时间（dTIRs）以及从其他基础胰岛素转换患者的疗效与安全性数据，为临床实践提供更为丰富的证据基础。《国际糖尿病》特别邀请到陈莉明教授为我们介绍相关结果并解读其带来的启示。 1. 中国INITIATION研究快速回顾中国INITIATION研究是一项为期24周、前瞻性、干预性、单臂、多中心、IV期研究，纳入了568例血糖控制不佳的T2DM成人患者，包括191例胰岛素初治患者和377例从其他基础胰岛素转换的患者，主要终点是从基线到第24周的糖化血红蛋白（HbA1c）变化。研究共纳入受试者568例，其中男性占57.7%，平均年龄56.2岁，平均糖尿病病程为9.87年，基线时平均HbA1c为8.49%。在血糖控制不佳的中国T2DM患者中，甘精胰岛素U300治疗24周可显著降低HbA1c水平达0.91%，且低血糖风险较低。无论胰岛素初治还是其他基础胰岛素转换的T2DM患者，甘精胰岛素U300治疗24周均可使HbA1c显著下降，分别下降1.38%和0.68%，且两组低血糖发生风险均较低。中国INITIATION研究最新数据抢“鲜”看 2. 在血糖控制不佳的中国T2DM患者中，甘精胰岛素U300治疗24周可显著改善总人群及胰岛素初治和基础胰岛素转换患者的dTIRs，分别提高16.99%、28.70%和11.47%；总人群中达到dTIR≥70%的患者比例为52.4%。在从其他基础胰岛素转换的中国T2DM患者中，甘精胰岛素U300治疗24周可降低HbA1c 0.87%，空腹血糖（FPG）和自我监测血糖（SMBG）均显著降低。在从其他基础胰岛素转换的中国T2DM患者中，甘精胰岛素U300治疗24周，低血糖风险较低，且未增加体重。大咖解读·精彩视频中国INITIATION研究最新结果重磅亮相：甘精胰岛素U300显著改善dTIRs，从其他基础胰岛素换用甘精胰岛素U300安全有效稳控为先，甘精胰岛素U300显著改善中国T2DM患者的dTIRs 近年来，新型血糖控制效果评价指标——血糖变异性（GV）越来越受到临床关注。2023年美国糖尿病协会（ADA）《糖尿病医学诊疗标准》[9]推荐通过连续血糖监测（CGM）进行血糖评估，并指出，作为血糖监测的新指标，TIR与微血管并发症的风险相关，有助于更全面评估血糖控制与患者预后。当无法使用CGM时，dTIRs可以作为评估血糖控制的重要指标。INITIATION研究事后分析评估了从基线到第24周dTIRs的变化，并计算了达到dTIR≥70%、dTIR改善≥5%和三重复合目标[dTIR≥70%、衍生低于目标范围时间（dTBR＜4%）和衍生高于目标范围时间（dTAR）＜25%]的患者比例。结果显示：在第24周时，与基线相比，总体人群的dTIR得到了显著改善，最小二乘均值（LSM）变化为16.99%，P<0.0001；在胰岛素初治组以及从其他基础胰岛素转换的群体中，dTIR均显著改善，LSM变化分别为28.70%和11.47%。 24周时，52.4%的患者实现了dTIR≥70%，35.0%达到了三重复合目标，2个亚组结果与总体人群相似。第24周时，总体人群中实现dTIR改善≥5%的比例为58.7%，其中胰岛素初治组（71.1%）高于基础胰岛素转换组（52.7%）。表1.自基线至24周的dTIRs分析研究表明，对于血糖控制不佳的中国成人T2DM患者，无论是胰岛素初治还是从其他基础胰岛素转换，甘精胰岛素U300均可有效改善dTIRs，有助于减少患者血糖波动，实现更精细的血糖管理。更胜一筹——中国T2DM患者从其他基础胰岛素转为甘精胰岛素U300，血糖控制显著改善，且安全性良好在探索中国成人T2DM患者血糖控制优化的进程中，甘精胰岛素U300脱颖而出。不仅胰岛素初治患者能够从其对dTIRs的改善中获益，同时，对于已接受其他基础胰岛素治疗但血糖控制不佳的患者而言，转为甘精胰岛素U300同样带来了积极影响。值得一提的是，中国INITIATION研究的亚组分析，聚焦于基础胰岛素治疗未达标（HbA1c 7.5%–11.0%）或低血糖频发以及低血糖高风险的患者群体，为从其他基础胰岛素转换至甘精胰岛素U300的疗效与安全性领域提供了宝贵见解。中国INITIATION研究纳入了377例使用其他基础胰岛素，血糖控制不佳或血糖控制尚可但频繁出现低血糖或低血糖风险高的T2DM患者，转为甘精胰岛素U300治疗。患者平均年龄为57.2岁，平均病程为11.02年，基线HbA1c为8.71%，基线时有302例患者HbA1c未得到控制。既往使用的基础胰岛素主要为甘精胰岛素U100（76.8%）和德谷胰岛素（18.2%）。第24周时，观察到HbA1c较基线下降0.87%，差异具有统计学意义，空腹血糖（FPG）和自我监测血糖（SMBG）均显著降低。平均每日基础胰岛素剂量从基线时的18.86 U（0.27 U/kg）增加到第24周时的28.83 U（0.41 U/kg）。在24周治疗期间，21例（7.0%）受试者发生了确诊的<3.0 mmol/L低血糖事件；2例（0.7%）受试者发生了严重低血糖事件。治疗24周后，未记录到显著的体重变化。表2. 24周时关键疗效与安全性结果研究表明，对于既往使用其他基础胰岛素治疗血糖控制不佳、或频繁出现低血糖或低血糖风险增加的中国T2DM患者，转为甘精胰岛素U300显著改善了血糖控制，同时低血糖风险相对较低且未出现体重增加，为这类患者的胰岛素治疗转换提供了强有力的证据支持。 Leading PI之声陈莉明教授天津医科大学朱宪彝纪念医院中国INITIATION研究是一项针对中国T2DM患者使用甘精胰岛素U300的临床研究，其独特性体现在两方面：一是研究设计，不仅覆盖了胰岛素初治患者，还纳入了基础胰岛素治疗转换人群，包括血糖控制不佳，以及血糖控制尚可但频繁出现低血糖或低血糖风险高的患者，补充了国内T2DM人群在既往其他基础胰岛素控制不佳转换为甘精胰岛素U300治疗的证据空白；二是其作为上市后研究，研究设计更加接近真实临床实践环境，为验证甘精胰岛素U300在中国患者中的有效性和安全性提供了坚实的循证证据。本次公布的中国INITIATION研究的事后分析和亚组分析结果再次证实了甘精胰岛素U300在中国T2DM患者管理中的重要作用，为临床实践提供了宝贵的参考和启示： 01 血糖控制指标dTIRs的显著改善 TIR是全面评估血糖控制与患者预后的血糖监测指标，衍生TIR（dTIR）也可作为评估TIR的重要指标。大多数T1DM或T2DM患者的TIR控制目标应>70%，低于目标范围时间（TBR）（<3.9 mmol/L）<4%、TBR（<3.0 mmol/L）<1%。中国INITIATION研究事后分析显示，无论是总人群还是胰岛素初治组或基础胰岛素转换组，甘精胰岛素U300治疗均显著提升了dTIR，且超过一半的患者在24周时达到了≥70%的dTIR目标，表明甘精胰岛素U300能够有效稳定控制血糖水平，减少血糖波动。此外，也有超过1/3的患者实现了三重复合目标，进一步验证了其全面改善血糖控制的能力。 02 基础胰岛素转换患者的显著获益对于基础胰岛素治疗控制不佳的中国T2DM患者，转换为甘精胰岛素U300后，不仅HbA1c、FPG和SMBG水平显著下降，且低血糖事件发生率低，体重无显著增加。这证明了在真实世界临床实践中，甘精胰岛素U300能够作为有效的胰岛素升级治疗选择，帮助患者克服既往基础胰岛素治疗中的不足，实现更安全、有效的血糖控制，可有效降低患者因频繁低血糖而中断治疗的风险。小结综上，中国INITIATION研究及最新数据进一步证实，甘精胰岛素U300使安全、有效、平稳的控糖真正成为现实，不仅适用于胰岛素初治患者，也是其他基础胰岛素治疗血糖控制不佳、低血糖频发或风险增加患者转换治疗的理想选择。未来，期待更多关于其长期疗效、安全性以及在不同患者群体中的应用研究，以更好地指导临床实践，提高糖尿病的整体管理水平。同时，也希望能够有更多的创新药物和治疗策略涌现，共同推动糖尿病治疗的进步和发展。聚焦前沿·快闪播报参考文献：（上下滑动查看更多） 1. Becker RH, et al. Diabetes Care 2015,38(4):637-643. 2. Bailey T, et al. Diabetes Metab 2018,44(1):15-21. 3. Ritzel R, et al. Diabetes Obes Meta 2015,17(9):859-867. 4. Rosenstock J, et al. Diabetes Care 2018,41(10):2147-2154. 5. Liming Chen, et al.Efficacy and safety of insulin glargine 300 U/mL in people with T2D in China: the INITIATION study.IDF23 - 0184. 6. Liming Chen, et al.Efficacy and safety of insulin glargine 300 U/mL in people with T2D in China: Subanalysis of the INITIATION study.IDF23 - 0185. 7. Liming Chen et al. Insulin glargine 300 U/mL improved derived time-in-ranges in people with type 2 diabetes in China: A post hoc analysis of the INITIATION study. 8. Liming Chen et al.Efficacy and safety of switching to insulin glargine 300 U/mL in people with type 2 diabetes uncontrolled on basal insulin in China. 9. ADA. Diabetes Care Volume 46, Supplement 1, January 2023. 声明：本文仅供医疗卫生专业人士了解最新医药资讯参考使用，不代表本平台观点。该等信息不能以任何方式取代专业的医疗指导，也不应被视为诊疗建议，如果该信息被用于资讯以外的目的，本站及作者不承担相关责任。 MAT-CN-2419199/V1.0/2024.11 最新《国际糖尿病》读者专属微信交流群建好了，快快加入吧！扫描左边《国际糖尿病》小助手二维码（微信号：guojitnb），回复“国际糖尿病读者”，ta会尽快拉您入群滴！（来源：《国际糖尿病》编辑部）版权声明版权属《国际糖尿病》所有。欢迎个人转发分享。其他任何媒体、网站未经授权，禁止转载。

临床结果

2024-11-15

·医药魔方Info

专利事件| 奥妥珠单抗、立他司特专利到期，罗特西普专利权获得延期

为助力医药行业专利从业者第一时间获取最新专利事件及进展，医药魔方推出了专利事件栏目，将每周对药品相关重要专利事件进行汇总，主要涉及：专利登记/声明、药品专利到期、专利复审与无效、专利PTE/PTA获批等情报。专利情报数据均来源于医药魔方NextPat数据库。本周（2024.11.04-2024.11.10）主要涉及以下内容： 1.中国上市药品专利登记及仿制药专利声明重点内容简介：本周CDE中国上市药品专利信息登记平台新增登记药品专利14件，涉及BMS的伊匹木单抗注射液、AstraZeneca的马来酸阿可替尼片、Amgen和CSL Vifor的阿伐可泮胶囊、锐康迪医药的磷酸奥唑司他片等。 2.美国FDA桔皮书、紫皮书、美国PTE专利新增重点内容简介：本周FDA桔皮书新增专利数十件，涉及品种Tosymra（舒马曲坦鼻腔喷雾剂）、Rinvoq（乌帕替尼）、Jardiance（恩格列净）等。Qtern（达格列净+沙格列汀）、Qternmet Xr（达格列净+沙格列汀+二甲双胍）、Fintepla（芬氟拉明口服液）的专利增加半年期的儿科用药期限延长（PED）。 3.中国药品专利到期精选重点内容简介：2024-11-05日，罗氏制药的奥妥珠单抗的中国序列结构核心专利CN'231B期限届满失效，该专利是奥妥珠单抗登记在CDE专利信息登记平台中的唯一专利。立他司特的两件马库什化合物专利CN'195B、CN'160B期限届满失效，立他司特的具体化合物专利CN'557A在国内未被授权，原研立他司特滴眼液并未在国内上市，国内已有两家提交仿制药上市申请。 4. 中国药品专利复审、无效情况精选重点内容简介：在药品专利复审方面，本周多件药品相关专利有复审决定/结案发文，或被驳回后提交了复审请求，涉及哌柏西利、环硅酸锆钠、舒西利单抗、米吉珠单抗、非奈利酮等。本周内有1件药品相关专利无效决定发文，多替诺雷的晶型专利CN110914246B被宣告专利权全部无效，无效宣告请求人为杭州中美华东制药有限公司（参见此前报道：呋喹替尼和多替诺雷晶型专利均被宣告全部无效）。 5. 中国药品专利PTE、PTA情况精选重点内容简介：列举了部分本周获批专利权期限补偿（PTA）的药品相关专利，例如罗特西普的序列专利CN'517B获得435天的专利权期限补偿、“甘精胰岛素+利司那肽”的制剂专利CN'442B获得40天的专利权期限补偿、恩替司他的医药用途专利CN'403B获得122天的专利权期限补偿等。药品专利事件周报的详细内容请点击阅读原文查看，或者加入文末医药魔方专利信息群获取。医药魔方专利信息群，旨在提供医药行业专利重点事件监控和解读，群内提供以下信息： 1. 及时的医药专利无效信息、复审跟踪、PTE/PTA专利补偿提醒； 2. 中国上市药品专利登记平台最新登记/声明； 3. 桔皮书专利最新登记； 4. 热点医药专利事件解读； 5. 医药专利研究报告； 6. 医药专利相关资讯。目前免费开放中（限前500人）添加左下方微信号，备注“专利-公司-职位"，拉您进群；如想申请NextPat数据库试用，可扫右侧二维码申请试用。

专利无效专利到期

2024-11-12

·PRNewswire

Gan & Lee Pharmaceuticals Announced Positive Phase 1 Results for Its Oral GLP-1 Receptor Agonist GZR18 Tablet in Healthy Participants, Demonstrating 4.16% Weight Reduction in Two Weeks

After two weeks of treatment, GZR18 tablets resulted in an average weight reduction of up to 4.16%, with continued weight loss observed even after discontinuation. The pharmacokinetic profile supports a once-daily oral dosing regimen for GZR18 tablets. The safety and tolerability of GZR18 tablets align with the known safety characteristics of GLP-1 receptor agonists, with no unexpected safety signals during the study. BEIJING, Nov. 12, 2024 /PRNewswire/ -- Gan & Lee Pharmaceuticals (Gan & Lee, Shanghai Stock Exchange: 603087) announced the positive topline results of a Phase 1 clinical trial its oral glucagon-like peptide-1 receptor agonist (GLP-1 RA) GZR18 tablets in healthy participants in China. Statement: GZR18 tablet is an ivestigational drug and has not yet been approved in China. Gan & Lee Pharmaceuticals does not recommend the use of any unapproved drugs/indications. The Phase 1 clinical trial (CTR20240663) was a randomized, open-label, first-in-human study involving 92 participants, designed to assess the bioavailability, pharmacokinetics (PK), pharmacodynamics (PD), safety, and tolerability of GZR18 tablets in healthy adult participants. The study also evaluated the effect of meal timing on the drug's PK, PD, safety, and tolerability. In this study, GZR18 tablets were safe and well-tolerated, with the most common adverse events being gastrointestinal reactions, consistent with the established safety profile of GLP-1 based therapies. PK data indicated favorable absorption, supporting a once-daily oral regimen. Both single and multiple doses showed a dose-response relationship in terms of PK and PD parameters. Participants treated with the target dose of 60 mg daily for two weeks exhibited an average weight reduction of 4.16% from baseline. Furthermore, a week after stopping treatment, subjects continued to lose weight 0.51%, reaching an average total reduction of 4.67% compared to baseline. At 21 days after discontinuation, neither the participants' body weight nor BMI had returned to baseline values. About GZR18 Tablets GZR18 tablet is an investigational, once-daily oral GLP-1 receptor agonist developed by Gan & Lee Pharmaceuticals. It utilizes a small molecule absorption enhancer, SNAC (N-[8-(2-hydroxybenzoyl)amino] caprylate), to facilitate drug absorption in the stomach by resisting pepsin degradation, thus prolonging the drug's half-life and enhancing its bioavailability. GZR18 tablets are currently in global Phase 1 clinical development. Forward-looking statements Forward-looking statements are based on our expectations and assumptions as of the date of the statements. Actual results may differ materially from those expressed in these forward-looking statements due to a variety of factors, and we can give no assurance that such results will be achieved in the future. We undertake no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise. About Gan & Lee Gan & Lee Pharmaceuticals developed the first Chinese domestic insulin analog. Currently, Gan & Lee has six core insulin products, including five insulin analog varieties: long-acting glargine injection (Basalin®), fast-acting lispro injection (Prandilin™), fast-acting aspart injection (Rapilin®), mixed protamine zinc lispro injection (25R) (Prandilin™25), aspart 30 injection (Rapilin®30), and one human insulin injection - mixed protamine human insulin injection (30R) (Similin®30). The company has two approved medical devices in China, namely reusable insulin injection pen (GanleePen), and disposable pen needle (GanleeFine®). In China's 2024 National Insulin-Specific Centralized Procurement, Gan & Lee Pharmaceuticals ranked first among all selected companies in terms of procurement demand for insulin analogs. The company is also making strides in international markets, with the disposable pen needle (GanleeFine®) approved by the US Food and Drug Administration (FDA) in 2020 and received GMP inspection approval from the European Medicines Agency (EMA) in 2024. These achievements significantly boost Gan & Lee's competitiveness in both international and domestic markets. In the future, Gan & Lee will strive for comprehensive coverage in diabetes treatment. Moving forward with its mission to become a world-class pharmaceutical company, Gan & Lee will also actively develop new chemical entities and biological drugs, focusing on treatments for metabolic diseases, cardiovascular diseases, and other therapeutic areas. SOURCE Gan & Lee Pharmaceuticals WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

临床1期临床结果上市批准

100 项与甘精胰岛素相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D03250	甘精胰岛素	A10AE04	DB00047

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
糖尿病	列支敦士登	Sanofi-Aventis Deutschland GmbH	2000-06-09
糖尿病	挪威	Sanofi-Aventis Deutschland GmbH	2000-06-09
糖尿病	冰岛	Sanofi-Aventis Deutschland GmbH	2000-06-09
糖尿病	欧盟	Sanofi-Aventis Deutschland GmbH	2000-06-09
1型糖尿病	美国	Sanofi-Aventis U.S. LLC	2000-04-20
2型糖尿病	美国	Sanofi-Aventis U.S. LLC	2000-04-20

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
急性心肌梗塞	临床3期	阿根廷	Sanofi	2008-04-01
急性心肌梗塞	临床3期	墨西哥	Sanofi	2008-04-01
高血糖	临床1期	美国	Sanofi	2005-06-01
急性心肌梗塞	临床前	巴西	Sanofi	2008-04-01
急性心肌梗塞	临床前	加拿大	Sanofi	2008-04-01
糖尿病昏迷	临床前	加拿大	Sanofi	2008-04-01
糖尿病昏迷	临床前	阿根廷	Sanofi	2008-04-01
糖尿病昏迷	临床前	墨西哥	Sanofi	2008-04-01
糖尿病昏迷	临床前	巴西	Sanofi	2008-04-01
糖尿病昏迷	临床前	美国	Sanofi	2008-04-01

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT03798080 (LixiLan-L-CN, Pubmed \| Diabetes Obes Metab) 人工标引	临床3期	2型糖尿病 \| 高血糖	124	iGlarLixi	蓋齋獵製淵遞選積艱壓(餘積淵醖餘膚鹽窪獵齋) = 獵顧衊艱構獵願鑰遞遞顧簾築簾鹹選遞齋獵鬱 (廠糧鬱餘餘鹽鏇鹽蓋憲 ) 更多	积极	2024-10-03
				iGlar	蓋齋獵製淵遞選積艱壓(餘積淵醖餘膚鹽窪獵齋) = 夢衊鬱鬱襯觸觸鹽壓蓋顧簾築簾鹹選遞齋獵鬱 (廠糧鬱餘餘鹽鏇鹽蓋憲 ) 更多
NCT01524705 (FLAT-SUGAR, CTgov)	临床4期	2型糖尿病	102	Insulin Glargine+Exenatide+Metformin	襯憲鬱衊構淵遞鹽構夢(鑰顧築鑰選獵餘糧繭蓋) = 窪範簾膚夢廠醖齋鹽夢鹹餘夢網醖選蓋廠築夢 (範築繭憲鏇鑰網憲獵齋, 蓋觸衊顧壓糧鹽夢夢觸 ~ 顧窪製襯範遞觸淵鏇積) 更多	-	2023-12-29
ORIGIN (ESC2023)	N/A	Sex hormone-binding globulin (SHBG) \| testosterone	-	Glargine	積夢網鑰獵鏇網顧觸鹽(簾鏇鏇膚齋壓鏇網範製) = 憲鹽鏇餘醖蓋網鏇廠願醖選廠築積鏇膚夢鹹鬱 (願齋鑰窪淵鹹鬱遞齋鬱 )	-	2023-08-26
				Glargine	積夢網鑰獵鏇網顧觸鹽(簾鏇鏇膚齋壓鏇網範製) = 網簾廠積鑰廠鹹構願鹽醖選廠築積鏇膚夢鹹鬱 (願齋鑰窪淵鹹鬱遞齋鬱 )
NCT03874715 (GEMELLI X, CTgov)	临床3期	1型糖尿病	210	Insulin Aspart+Insulin glargine U100+Insulin Aspart SAR341402 (Switching: NovoLog/SAR341402)	醖遞膚衊襯糧願齋齋餘(艱鑰製獵鹹鑰獵鹹壓廠) = 憲顧鬱顧糧鑰繭構糧積繭糧網餘製膚窪簾繭窪 (蓋糧鏇獵蓋醖夢糧襯壓, 廠顧築繭憲壓壓鏇鏇鹹 ~ 選鹽繭淵衊顧齋願遞繭) 更多	-	2023-07-21
				Insulin Aspart+Insulin glargine U100 (Non-switching: NovoLog)	醖遞膚衊襯糧願齋齋餘(艱鑰製獵鹹鑰獵鹹壓廠) = 壓齋簾夢夢餘積顧簾簾繭糧網餘製膚窪簾繭窪 (蓋糧鏇獵蓋醖夢糧襯壓, 鬱蓋窪製鬱繭鬱構鹽築 ~ 鬱廠鬱淵襯鹹蓋願構襯) 更多
RESTORE-G (ADA2023)	N/A	-	-	Glargine 300 U/mL	(窪餘願範獵廠膚簾獵鏇) = 膚壓鬱壓鬱願鬱選窪鹹網廠鑰襯衊簾衊網膚憲 (窪構憲製網遞遞構壓製 )	-	2023-06-23
Pubmed	临床3期	2型糖尿病	-	iGlarLixi	簾繭遞範網膚鹹積鹹鏇(鏇憲範壓築願鹽醖製餘): P-Value = 11.45	-	2023-03-30
				Glargine 100 U/mL
EASD2022	N/A	2型糖尿病	-	Tirzepatide 5 mg	壓鹽鬱糧齋淵獵衊鬱鹹(鹽鹹遞遞製鏇觸衊醖艱) = The most frequent adverse events were gastrointestinal-related events that were mild to moderate in severity and occurred during the dose-escalation period 選願夢簾廠壓鑰積蓋窪 (壓觸淵網齋壓獵艱壓積 )	-	2022-09-21
				Tirzepatide 10 mg
NCT04567225 (CTgov)	临床4期	糖尿病酮症酸中毒 \| 2型糖尿病 \| 1型糖尿病	39	IV insulin infusion+Early Glargine (Early Glargine)	獵壓構築壓鹹衊鹹鹽衊(憲壓範衊選遞襯範鬱淵) = 糧網夢觸襯糧顧繭廠鹽鏇獵膚繭夢繭築願憲膚 (願範膚積網糧網繭蓋膚, 願齋鑰糧醖糧夢蓋繭膚 ~ 遞廠憲糧淵廠網糧壓網) 更多	-	2022-08-25
				IV insulin infusion+Late Glargine (Standard Practice (Late Glargine))	獵壓構築壓鹹衊鹹鹽衊(憲壓範衊選遞襯範鬱淵) = 衊鏇積艱範鹽構構簾艱鏇獵膚繭夢繭築願憲膚 (願範膚積網糧網繭蓋膚, 製鬱廠構網鑰構簾範衊 ~ 範糧餘製繭窪獵鏇願製) 更多
ADA2022	N/A	2型糖尿病	-	Continued treatment with Gla-300	繭鏇廠築壓網艱選願壓(憲鬱廠築鬱鏇製蓋構糧) = 繭製淵構積顧積網襯蓋觸製夢淵醖餘憲簾膚顧 (觸觸鹽顧獵獵簾構遞顧 ) 更多	-	2022-06-01
				Switched to 1st-gen BI analog (Gla-100 or IDet)	繭鏇廠築壓網艱選願壓(憲鬱廠築鬱鏇製蓋構糧) = 齋構淵鏇艱獵醖鑰製窪觸製夢淵醖餘憲簾膚顧 (觸觸鹽顧獵獵簾構遞顧 ) 更多
ADA2022	N/A	-	-	Insulin Glargine 100 U/mL (Gla-100)	(餘壓製構鏇範觸壓餘簾) = 築襯製膚範憲夢觸壓餘繭襯選觸憲築鹹窪膚繭 (醖範顧齋鬱憲繭憲簾鏇 )	积极	2022-06-01
				Insulin Glargine 300 U/mL (Gla-300)	(餘壓製構鏇範觸壓餘簾) = 遞鹽鹽遞齋顧醖製壓壓繭襯選觸憲築鹹窪膚繭 (醖範顧齋鬱憲繭憲簾鏇 )