Simultaneous Measurement and Responsive Treatment (SMART01): A Feasibility Study of the SynerG TM CGM sensor Integrated with the Niia Essential Insulin Patch Pump System in Persons with Type 1 Diabetes.

开始日期2025-03-24

申办/合作机构-

NL-OMON57171

/ SuspendedN/A

Phoenix: Clinical evaluation of the Medtronic Implantable Insulin Pump System (MIIPS 2020) in adult subjects with Type 1 Diabetes - Phoenix

开始日期2024-11-06

申办/合作机构-

100 项与 NNC0268-0965 相关的临床结果

登录后查看更多信息

100 项与 NNC0268-0965 相关的转化医学

登录后查看更多信息

100 项与 NNC0268-0965 相关的专利（医药）

登录后查看更多信息

122,466

项与 NNC0268-0965 相关的文献（医药）

2025-12-31·ANNALS OF MEDICINE

Bioengineering and omics approaches for Type 1 diabetes practical research: advancements and constraints

Review

作者: Li, Ling ; An, Zhenmei ; Peng, Yihua ; Peng, Xi ; Zhou, Guangju

Insulin dependency arises from autoimmunity that targets the β cells of the pancreas, resulting in Type 1 diabetes (T1D). Despite the fact that T1D patients require insulin for survival, insulin does not provide a cure for this disease or prevent its complications. Despite extensive genetic, molecular, and cellular research on T1D over the years, the translation of this understanding into effective clinical therapies continues to pose a significant obstacle. It is therefore difficult to develop effective clinical treatment strategies without a thorough understanding of disease pathophysiology. Pancreatic tissue bioengineering models of human T1D offer a valuable approach to examining and controlling islet function while tackling various facets of the condition. And in recent years, due to advances in high-throughput omics analysis, the genotypic and molecular profiles of T1D have become finer tuned. The present article will examine recent progress in these areas, along with their utilization and constraints in the realm of T1D.

2025-12-31·Journal of Pharmaceutical Policy and Practice

Emergency medicine pharmacists’ interventions in the tertiary hospitals’ emergency departments in Malaysia

Article

作者: Teh, Lih Jiuan ; Tan, Shirlyn ; Tan, Sherene Su Ann ; Bhuvanendran Pillai, Anaanthan ; Sia, Rosalind Guen Lin ; Guee, Xin Nee ; Selvaratanam, Manimegahlai ; Koh, Hock Peng ; Wong, Wai Kit ; Koo, Yee Ping ; Chen, Mary Siew Yng ; Ab Jalal, Haliza

Background:

The emergency medicine (EM) pharmacist is an integrated part of the Emergency Department (ED) interdisciplinary team in many countries, including Malaysia. The presence of EM pharmacists in the ED has positively impacted patient outcomes. Data on EM pharmacists' interventions is scarce in the Asian region. In Malaysia, data on interventions done by EM pharmacists in the EDs was unavailable. This study aimed to assess the type of interventions done by EM pharmacists in the ED of tertiary public hospitals in Malaysia.

Methods:

This cross-sectional, multicenter study involved EM pharmacists from 14 tertiary hospitals in Malaysia. All accepted interventions done by EM pharmacists in the ED for patients admitted to the Red (critical) and Yellow (semi-critical) zones from January to June 2022 were extracted from the Clinical Pharmacy Report Form. All data were analyzed descriptively.

Results:

The EM pharmacists documented 1659 accepted interventions on 1584 patients during the study period. Inappropriate regimens (n = 1117, 67.3%) and incomplete prescriptions (n = 339, 20.4%) were the main categories of accepted interventions in ED. Inappropriate drug (n = 574, 34.6%), dose (n = 292, 17.6%), and frequency (n = 176, 10.6%) were the top three subcategory interventions documented under inappropriate regimens. Antimicrobials, antihypertensives, and proton pump inhibitors were the commonest drug intervened under the categories of inappropriate drug intervention. There were 272 (16.4%) accepted interventions on high-alert medications (HAMs). Insulin, enoxaparin, and noradrenaline were the most intervened HAMs.

Conclusion:

Inappropriate treatment regimens were the most common intervention category done by EM pharmacists in Malaysia. The significant number of interventions done by EM pharmacists demonstrated the importance of EM pharmacists as integral members of the EM team. This data can help improve the quality of clinical pharmacy services in the ED and is important for the future expansion of clinical pharmacy services in all EDs across Malaysia, neighbouring countries, and other developing countries.

2025-12-31·Journal of Pharmaceutical Policy and Practice

Effect of statins and antihyperglycemics on chronic kidney disease in patients with type 2 diabetes mellitus: a retrospective cohort study with a 12-year follow-up

Article

作者: Mohammed, Khuloud Jamal ; El-Dahiyat, Faris ; Al Jaberi, Asma Khaled ; Shahwan, Moyad ; Al Jawamis, Dina Farhan ; Jairoun, Ammar Abdulrahman ; Ping, Chong Chee ; Ibrahim, Baharudin ; Dawoud, Tasnim

Background:

Chronic Kidney Disease (CKD) represents a significant worldwide health challenge, with far-reaching implications for both patients and healthcare systems. This study aimed to identify the incidence of CKD at stages 3-5, analyzed the impact of statin and other antihyperglycemic interventions, on the CKD progression in individuals with T2DM.

Methods:

This was a single-center retrospective cohort study based on data derived from electronic medical records (EMR) of UAE populations with diabetes mellitus, registered at outpatient clinics at Tawam Hospital in Al Ain, UAE, between January 2011 and December 2021. T2DM patients aged ≥ 18 years who had serum HbA1c level ≥ 6.5% and using one of the statin therapies were inclusion criteria. Patients with T1DM, who had undergone permanent renal replacement therapy, with under 1 year of follow-up and missing or incomplete data were excluded from the study. The collected data encompassed socio-demographics, detailed medical history, anthropometric measurements, laboratory analyses, clinical parameters, disease characteristics, and medications.

Results:

Our study included a cohort of 1,003 individuals. We observed 388 subjects developed CKD stages 3-5 across an average monitoring duration of 11.7 years. This resulted in a cumulative incidence of 38.7%, translating to an incidence rate of 38 cases per 1000 person-years. There was a statistically significant difference in the cumulative incidence of CKD stages 3 ± 5 according to statin therapy (P = 0.047). High intensity statin users are more likely to develop a CKD stage 3-5 compared to low/moderate intensity users and to no statin users respectively (44.3% vs 37.9%), (44.3% vs 30.9%). Conversely, the use of Biguanides was associated with a decreased probability of CKD progression (37.9% vs. 52.8%; P = 0.001), whereas Insulin users demonstrated a heightened risk (54.2% vs. 34.1%; P < 0.001).

Conclusion:

The findings emphasise the pivotal role of personalised treatment strategies, particularly concerning statin therapy and other medications, in populations at high risk.

978

项与 NNC0268-0965 相关的新闻（医药）

2025-07-24

·国际糖尿病idiabetes

ADA2025新视野：解锁CGM在非胰岛素治疗T2DM中的深层价值

点击“蓝字”关注我们在糖尿病管理领域，持续葡萄糖监测（CGM）技术的应用曾长期局限于胰岛素治疗人群，尤其是1型糖尿病患者及需强化胰岛素治疗的2型糖尿病（T2DM）患者。这类人群因低血糖风险高、血糖波动大，传统指尖采血监测频次难以满足临床需求，CGM的连续监测优势得以凸显。在2025年美国糖尿病协会（ADA）年会上，多项研究摘要揭示了CGM在非胰岛素治疗的T2DM患者中的应用效果，涵盖血糖控制、生活方式管理以及患者心理等多方面影响。本文将基于这些研究发现，阐述CGM在这类人群中的应用进展，以期为临床决策提供参考。CGM助力血糖精准调控：证据与发现传统的糖尿病饮食教育常面临依从性低、效果个体差异大的挑战。然而，多项研究一致证实，引入CGM可显著改善非胰岛素治疗T2DM患者的血糖控制指标。个性化饮食指导：基于CGM的血糖管理新路径一项针对124例非胰岛素治疗T2DM患者的随机对照试验，比较了在CGM启动期间，营养导向型干预（NFA，接受个性化饮食指导）与自我导向型干预（SDA，仅接受标准教育）的疗效差异。评估指标包括葡萄糖目标范围内时间（TIR）、饮食质量（HEI评分）和糖尿病痛苦量表。结果显示，两组的TIR均显著改善（NFA组：+25%，SDA组：+16%），但组间无显著差异（P=0.14）（图1）。NFA组>250 mg/dl时间减少更显著（-14% vs. -6%，P=0.047）。此外，NFA组饮食质量提高（HEI评分：+5分），而SDA组无变化。并且，NFA组对使用CGM的信心提升相较于SDA组更高（35% vs. 9%，P=0.02）[1]。图1. NFA组和SDA组的TIR改变另一项针对新诊断T2DM患者的随机对照研究显示，基于CGM数据的个性化饮食建议对患者的血糖控制与自我管理效能有显著改善作用。该研究将108例患者随机分为标准饮食教育组与CGM干预组。干预组通过可穿戴CGM设备监测1周，结合数字平台动态分析血糖波动规律，并据此提供定制化饮食反馈。3个月后，干预组糖化血红蛋白（HbA1c）降幅较对照组更显著（P=0.02），糖尿病自我管理行为量表（DSCSA）评分（P<0.001）和患者满意度显著提高（P=0.03）。亚组分析提示，年轻、高体重及基线血糖水平较高者获益更显著[2]。数字化干预的"剂量-反应"关系此外，一项对数字糖尿病自我管理教育与支持（DSMES）与CGM整合方案的随机对照试验的二次分析表明，患者对方案的参与度与HbA1c的降低幅度密切相关。具体而言，总参与度处于平均水平的受试者从基线到6个月HbA1c降低1.08%（P<0.001），葡萄糖高于目标范围时间（TAR）降低16.63%（P=0.002），TIR增加16.54%（P=0.001）。总参与度高（+1 SD）的受试者HbA1c降低1.71%（P<0.001），葡萄糖管理指标（GMI）降低1.37%（P<0.001），TAR降低32.92%（P<0.001），平均血糖降低56.41 mg/dl（P<0.001），TIR增加32.86%（P<0.001）；而参与度低（-1 SD）受试者的各指标无显著变化。由此可见，更高参与度的数字DSMES与CGM整合方案有望带来更佳长期糖尿病管理效果[3]。CGM在多元人群中的普适性获益一项纳入241例非胰岛素治疗的T2DM患者的全球注册研究的初步结果显示，在基层医疗场景中使用CGM与HbA1c改善相关。研究发现，CGM使用与3、6个月时HbA1c显著改善，3个月时体重和BMI下降，以及2~6个月TIR、TAR和平均血糖改善相关（表1）[4]。表1. 全球注册研究中基于HbA1c、体重和CGM的结果针对老年非胰岛素治疗T2DM患者的亚组分析显示，无论患者年龄如何（≥65岁或＜65岁），在糖尿病自我管理教育（DSME）基础上使用间歇扫描式CGM（isCGM）均可增加TIR（表2），为CGM在老年非胰岛素治疗T2DM患者中的应用提供了有力支持[5]。表2. 按年龄分层后isCGM+DSME的结果在探索最新技术的研究中发现，使用结合人工智能（AI）食品识别技术的isCGM方案，可使HbA1c在6个月时下降0.34%（P=0.041），且严格的葡萄糖目标范围内时间（TITR）也有改善的趋势（P=0.086）（图2）[6]。图2. isCGM+AI对HbA1c和TIR的影响这些证据表明，CGM能够助力非胰岛素治疗的糖尿病患者获得更好的整体血糖控制，有效降低HbA1c水平，这对于预防糖尿病并发症具有重要的临床意义。CGM 驱动生活方式变革：从短期洞察到长期习惯养成CGM的价值不仅体现在血糖指标的改善上，更在于其能显著提升患者对生活方式与血糖关系的认知，进而促进健康行为的长期改变。短期使用CGM的“觉醒效应”在丹麦开展的一项研究中，纳入724例非胰岛素治疗T2DM患者，为其提供14天CGM设备，并仅给予最低限度的指导。结果显示，大部分（80%）患者认为CGM非常有用且信息丰富。与病程>5年者相比，病程<5年者每日扫描频率更高（80% vs. 71%），且能更清晰识别食物种类（88% vs. 78%）、摄入量（80% vs. 60%）和运动（65% vs. 55%）对血糖的影响。3个月后，50%的患者维持了基于CGM洞察的饮食/运动习惯。这些发现表明，即使短期的CGM使用，也能促进患者理解生活方式对血糖的影响，且这一效果不受教育水平限制[7]。CGM对自我管理行为的积极影响一项针对156例非胰岛素治疗T2DM患者的真实世界观察研究显示，CGM使用3个月后，患者在饮食和运动方面的自我管理行为均有改善。具体而言，患者报告的糖尿病相关困扰显著减少，含糖饮料、甜点和酒精的摄入量明显减少，而对健康饮食计划和运动锻炼的依从性有所提高（均P<0.05）。同时，年轻患者（<45岁）的TIR从最初10天的68%提升到最后10天的86%，血糖高于250 mg/dl的时间从13%降至2%，展现出显著的血糖改善。女性患者在佩戴CGM期间糖尿病相关困扰较基线显著降低。这些数据表明，CGM不仅提供客观的血糖信息，还能在心理层面减轻患者的负担，增强自我管理的信心和动力[8]。CGM 应用拓展：特殊人群中的突破新生儿低血糖是导致神经发育障碍的重要风险因素，但传统的床旁血糖即时检测（POC）可能遗漏25%的低血糖事件。结果表明，通过引入一种实时重校准算法，仅需在佩戴传感器的第一天使用2次POC测量值进行校准，即可将CGM的平均绝对相对误差（MARD）从40%降至12%，平均符号误差从25 mg/dl降至3.5 mg/dl，显著提升了准确性[9]。针对ICU中危重患者的研究显示，总体MARD为23%，41%的传感器数值符合15/15准则。传感器倾向于高估血糖值，平均差值为+25 mg/dl。然而，无论患者是否存在糖尿病、是否使用静脉胰岛素或是否使用血管加压药物，对CGM的准确性并无显著影响[10]。小结从胰岛素治疗患者的“刚需工具”到非胰岛素治疗患者的“预防性武器”，CGM的应用扩展标志着糖尿病管理从“反应性干预”向“前瞻性防控”的转型。其核心价值不仅在于数据采集，更在于通过实时反馈、AI分析和行为干预构建闭环管理生态。展望未来，随着技术进步和应用范围的进一步拓展，CGM有望成为全球糖尿病患者血糖管理的核心工具，为提升健康结局作出更大贡献。参考文献（上下滑动可查看）[1] Holly J. Willis, et al. 234 OR: Impact of Initiating Continuous Glucose Monitoring in People with Type 2 Diabetes Not on Insulin: A Randomized Controlled Trial. ADA 2025.[2] Heng Wan, et al. 6-OR: The Effectiveness of Personalized Dietary Advice Based on CGM Data for Newly Diagnosed Patients with Type 2 Diabetes. ADA 2025.[3] Jeanean B. Naqvi, et al. 157-OR: Higher Engagement with a Digital DSMES + CGM Program Is Associated with More Robust Improvements in Glycemic Control. ADA 2025.[4] Amir Herman, et al. 1495-P: Improved A1C in People with Non–Insulin-Treated T2D Using CGM in Primary Care—The Dexcom Global Registry. ADA 2025.[5] Caity Decara, et al. 1025-P: Effect of Intermittently Scanned Continuous Glucose Monitoring in Older Adults with Type 2 Diabetes on Noninsulin Therapy—A Post Hoc Analysis of a Randomized Clinical Trial. ADA 2025.[6] Sun Joon Moon, et al. 1029-P: Periodic Use of Intermittently Scanned CGM with AI Food Camera in Non-insulin-Treated Type 2 Diabetes—A Randomized Clinical Trial. ADA 2025.[7] Emma Munch Nielsen, et al. 8-OR: Short-Term Continuous Glucose Monitoring Reveals Insights and Promotes Behavioral Awareness in People with Non-Insulin-Treated Type 2 Diabetes, Even after Minimal Instructions. ADA 2025.[8] Margaret A. Crawford, et al. 1927-LB: Real-World Dexcom CGM Use in T2D NIT—Reduced Diabetes Distress and Improved Self-Care Behaviors. ADA 2025.[9] Francesco Prendin, et al. 230-OR: A Real-time Recalibration Algorithm To Improve The Accuracy Of CGM Sensors In Newborns. ADA 2025.[10] Jagdeesh Ullal. 231-OR: Dexcom G6 Pro Accuracy and Reproducibility in the Intensive Care Unit. ADA 2025.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。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

2025-07-23

·Business Wire

New Study Using Aptar’s Nasal Drug Delivery System Validates Insulin Nasal Spray to Deliver Alzheimer’s Drug Directly to the Brain

CRYSTAL LAKE, Ill.--(BUSINESS WIRE)--AptarGroup, Inc. (NYSE: ATR), a global leader in drug and consumer product dosing, dispensing and protection technologies, today announced that its nasal drug delivery system was used in a recently published brain imaging study from Wake Forest University School of Medicine. According to the university’s press release, the “groundbreaking” study confirms a vital step toward new Alzheimer’s treatments: intranasal insulin, delivered via nasal spray, safely and effectively reaches key memory regions of the brain in older adults. The study also revealed that people with early cognitive decline may absorb it differently. This research, published in Alzheimer’s & Dementia: Translational Research & Clinical Interventions, describes the results of a milestone positron emission tomography (PET) imaging study. According to the Wake Forest team, the results directly show that intranasal insulin travels to 11 key brain regions associated with memory and cognition. Previously, researchers faced challenges in earlier intranasal insulin trials because they could not confirm if the treatment was reaching its brain targets. The imaging protocol used a precision nasal delivery system supplied by Aptar Pharma, and could be adapted for other intranasal therapies targeting neurological disorders. “The results of the study represent a significant step forward in medicine as they validate that our nasal delivery system was effective in delivering intranasal insulin safely and effectively to specific regions of the brain,” said Reenal Gandhi, Aptar Pharma’s Director of Business Development. “Aptar has over 30 years of experience in nasal drug delivery system, including in the area of neurodegenerative diseases, and the patient is at the center of everything we design. While we have nasally delivered medications in emergency and routine care, we believe that the nasal route holds potential for more developments. As scientific understanding and development advance, we see continued opportunities for intranasal delivery to improve how therapeutics are delivered to the central nervous system.” “This study fills a critical gap in our understanding of how intranasal insulin reaches the brain,” said Suzanne Craft, Ph.D., professor of gerontology and geriatric medicine at Wake Forest University School of Medicine and director of the Wake Forest Alzheimer’s Disease Research Center. “We needed direct evidence that the drug is able to reach key brain targets. An unexpected finding was the observation that uptake may differ in people with early cognitive decline. This means we now have a roadmap directly to the brain.” The Wake Forest study involved 16 older adults (average age 72), including seven who were cognitively normal and nine with mild cognitive impairment (MCI). Using a novel radiotracer, [68Ga]Ga-NOTA-insulin, delivered with a specialized six-spray nasal system, participants underwent a 40-minute brain PET scan followed by whole-body imaging. Participants described the nasal spray as “surprisingly easy.” The researchers found: Elevated insulin uptake in critical memory and cognition areas, including the hippocampus, olfactory cortex, amygdala and temporal lobe. Cognitively normal individuals showed higher uptake and distinct timing patterns of insulin delivery compared to those with MCI, who exhibited rapid initial uptake followed by quicker clearance. In women, insulin uptake correlated strongly with factors linked to healthy cardiovascular function and elevated ptau217 levels (a marker of brain amyloid, the sticky protein that accumulates in the brain in Alzheimer’s disease) were associated with decreased brain absorption across multiple regions. Only two participants reported mild headaches post-scan, which resolved within 24 hours, indicating the procedure was well-tolerated. “One of the biggest challenges in developing treatments for brain diseases is getting agents into the brain,” Craft said. “This study shows we can validate intranasal delivery systems effectively, an essential step before launching therapeutic trials.” Given recent concerns around the limited efficacy and side-effect profiles of some anti-amyloid drugs, this validation strategy supports a broader approach to Alzheimer’s treatment, including metabolic and delivery-focused interventions. The findings could help explain why some patients respond better to intranasal insulin therapy than others, potentially leading to personalized treatment approaches. “There’s an urgent need to identify effective and feasible ways to prevent and treat Alzheimer’s dementia,” said Craft. “These findings show that we can now validate whether treatments are actually reaching their intended brain targets, which is critical information for designing successful trials.” The Wake Forest team is now planning larger validation studies within the next 12-18 months to explore how vascular health, amyloid accumulation and sex differences influence brain insulin delivery. “While there’s still a lot to learn, these findings show that we now have the tools to validate intranasal drug delivery to the brain,” Craft said. “This is promising news for developing more effective and accessible treatments for Alzheimer’s disease.” Aptar offers a full range of Orally Inhaled and Nasal Drug Product (OINDP) systems and services to support this growing sector. Aptar offers advanced intranasal drug delivery services, including everything from manufacturing, formulation development all the way through to clinical and commercial product manufacturing. Aptar’s nasal spray systems are designed to reliably deliver precise nasal drug dosing in an easy to use, safe, and portable package for both systemic and local administration with rapid onset capabilities. About Aptar Aptar is a global leader in drug and consumer product dosing, dispensing and protection technologies. Aptar serves a number of attractive end markets including pharmaceutical, beauty, food, beverage, personal care and home care. Using market expertise, proprietary design, engineering and science to create innovative solutions for many of the world’s leading brands, Aptar in turn makes a meaningful difference in the lives, looks, health and homes of millions of patients and consumers around the world. Aptar is headquartered in Crystal Lake, Illinois and has over 13,000 dedicated employees in 20 countries. For more information, visit www.aptar.com. This press release contains forward-looking statements, including the potential outcomes of the nasal delivery system for intranasal insulin. Forward-looking statements generally can be identified by the fact that they do not relate strictly to historical or current facts and by use of words such as “expects,” “anticipates,” “believes,” “estimates,” “future,” “potential,” “continues” and other similar expressions or future or conditional verbs such as “will,” “should,” “would” and “could” are intended to identify such forward-looking statements. Forward-looking statements are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and are based on our beliefs as well as assumptions made by and information currently available to us. Accordingly, our actual results or other events may differ materially from those expressed or implied in such forward-looking statements due to known or unknown risks and uncertainties that exist in our operations and business environment including, but not limited to: the successful integration of acquisitions; the regulatory environment; and competition, including technological advances. For additional information on these and other risks and uncertainties, please see our filings with the Securities and Exchange Commission, including the discussion under “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our Form 10-K and Forms 10-Q. We undertake no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise, except as otherwise required by law.

临床结果

2025-07-22

·国际糖尿病idiabetes

1+1＞2！GLP-1RA联合基础胰岛素，为T2DM患者提供更优治疗选择

点击“蓝字”关注我们编者按随着2型糖尿病（T2DM）治疗策略的不断演进，早期联合治疗已经成为临床管理的重要趋势[1]。GLP-1受体激动剂（GLP-1RA）与基础胰岛素的联合使用，凭借其显著的血糖控制、体重管理以及其他获益，已被证明为一种高效且安全的治疗选择[2]。近期，荟萃分析[3]和真实世界数据[4-5]进一步支持了这一方案的优势，特别是在优化基础胰岛素的选择上，二代基础胰岛素显示出更优的疗效。我们特邀广州医科大学附属第一医院陈小燕教授分享相关研究成果，探讨这一治疗策略最新进展，为临床实践提供宝贵的循证依据。1+1＞2！GLP-1RA联合基础胰岛素为T2DM患者提供更有效选择随着临床研究的持续深入，GLP-1RA与基础胰岛素的联合治疗已逐渐成为T2DM管理中的重要治疗策略。最近，Clinical Nutrition ESPEN发表的一项系统评价与荟萃分析[3]，深入探讨了司美格鲁肽联合基础胰岛素治疗T2DM患者的疗效与安全性。该研究进一步证实，GLP-1RA与基础胰岛素的联合应用能够实现“1+1＞2”的显著疗效，展现出综合治疗的优势，为T2DM患者提供了更为有效的治疗选择。这项荟萃分析共纳入了7项随机对照试验（RCT），共2354名患者。其中司美格鲁肽组1248例，对照组1106例。所有研究均采用平行组设计，其中1项为开放标签试验。样本量范围为60~1578例，干预持续时间为3~12个月。结果显示，与安慰剂或其他治疗方法相比，司美格鲁肽与基础胰岛素联合使用可显著降低糖化血红蛋白（HbA1c）[均值差（MD）：-1.17%，P<0.00001]、体重（MD -5.99 kg，P<0.00001）和空腹血糖（FPG）（MD -1.08%，P<0.00001）。此外，联合治疗还可优化血脂代谢[包括显著降低总胆固醇（TC）、甘油三酯（TG）、低密度脂蛋白（LDL），以及显著增加高密度脂蛋白（HDL）]、减少胰岛素用量。与此同时，不增加低血糖的发生风险（RR 1.36，P=0.26）。综上，该荟萃分析表明，GLP-1RA与基础胰岛素的联合治疗在血糖控制和体重减轻方面表现出显著改善，且未增加低血糖的风险。研究结果支持在T2DM患者中使用司美格鲁肽与基础胰岛素的联合治疗。择“优”联用！二代基础胰岛素是GLP-1RA控糖不佳时的更优选择在越来越多的循证证据支持下，《胰高糖素样肽-1受体激动剂联合胰岛素治疗2型糖尿病专家共识（2025版）》[6]指出，对于口服降糖药治疗血糖控制不佳的T2DM患者可起始基础胰岛素和GLP-1RA联合治疗；同时当患者通过改变生活方式、口服降糖药和 GLP-1RA无法使血糖控制达标时，需要开始使用胰岛素，这是病情发展所需。2025版《ADA糖尿病诊疗标准》[2]同样指出，当采用GLP-1RA治疗无法达到血糖目标时，需及时添加基础胰岛素治疗。真实世界研究RESTORE-G[4-5]显示，与一代基础胰岛素相比，二代基础胰岛素联合GLP-1RA治疗效果更优。RESTORE-G研究是一项真实世界、干预性、回顾性、队列研究，纳入2011至2021年期间接受GLP-1RA±口服降糖药物治疗的T2DM患者，患者改变治疗方案，起始一代基础胰岛素或二代基础胰岛素治疗，研究设计和分组情况见下图。图. RESTORE-G研究的设计情况图. RESTORE-G研究的分组情况结果显示：GLP-1RA控制不佳后，无论是联合还是转换治疗，与一代基础胰岛素相比，二代基础胰岛素均可实现更好的血糖控制。在联合治疗中，与一代基础胰岛素相比，二代基础胰岛素均可进一步降低HbA1c（估计均值差：-0.32%，P=0.04）和FPG（-1.15 mmol/L，P=0.007）。图. GLP-1 RA控制不佳的患者，联合二代基础胰岛素可实现更好的血糖控制在转换治疗中，与一代基础胰岛素相比，二代基础胰岛素同样可进一步降低HbA1c（估计均值差：-0.22%，P=0.03）和FPG（-0.56 mmol/L，P=0.03），并且体重增加更少（-0.67 kg，P=0.04）。图. GLP-1 RA控制不佳的患者，转为二代基础胰岛素可实现更好的血糖控制与固定比例组合德谷利拉相比，GLP-1RA自由联合甘精胰岛素U300对于FPG改善更显著（-1.4 mmol/L，P=0.0003），而HbA1c改善与体重变化相似。这与自由联合方案更加灵活，不同成分滴定更充分有关。图. 与固定比例组合德谷利拉相比，GLP-1RA自由联合甘精胰岛素U300治疗，FPG改善更显著综上，该真实世界研究表明，对于GLP-1RA治疗控制不佳的T2DM患者，联合或转换基础胰岛素，尤其是二代基础胰岛素是有价值的选择。总结GLP-1RA联合基础胰岛素已被证明是一种有效的T2DM治疗方案，能够显著改善血糖控制、体重管理和血脂水平，且不增加低血糖的风险。最新的系统评价与荟萃分析显示，司美格鲁肽与基础胰岛素联合使用在多个疗效指标上优于单独使用其他治疗方案。在基础胰岛素的选择上，二代基础胰岛素具有显著优势。真实世界RESTORE-G研究表明，与一代基础胰岛素相比，联合或转换二代基础胰岛素能更有效降低HbA1c和FPG。这些研究结果表明，GLP-1RA与基础胰岛素的联合治疗，尤其是与二代基础胰岛素联用，为T2DM患者提供了更为优效的治疗方案。专家简介陈小燕教授广州医科大学附属第一医院三级主任医师、医学博士、硕士生导师、博士后合作导师广州医科大学附属第一医院内分泌科科主任南山学院内分泌模块教研室负责人第三届“羊城好医生”、“岭南名医”广州市医学会内分泌分会副主委广东省保健协会糖尿病分会主委中国民族卫生协会糖尿病分会常委广东省营养学会公共营养专委会副主委广东省保健协会甲状腺保健分会副主委广东省健康管理学会代谢与内分泌分会副主委广东省精准医学应用学会更年期健康分会副主委广东省医学会内分泌分会常委广东省药理学会内分泌代谢药理专委会副主委中国老年医学学会骨质疏松分会妇产科学专委会委员参考文献：（上下滑动查看更多）[1]中华医学会糖尿病学分会. 中国糖尿病防治指南（2024版）. 中华糖尿病杂志，2025，17(01):16-139. DOI:10.3760/cma.j.cn115791-20241203-00705.[2]American Diabetes Association Professional Practice Committee. 9. Pharmacologic Approaches to Glycemic Treatment: Standards of Care in Diabetes-2025. Diabetes Care. 2025 Jan 1;48(1 Suppl 1):S181-S206. doi: 10.2337/dc25-S009. PMID: 39651989; PMCID: PMC11635045.[3]Chen B, Tao L, Tian M, et al. Efficacy and safety of combination of semaglutide and basal insulin in patients with of type 2 diabetes mellitus: A systematic review and meta-analysis. Clin Nutr ESPEN. 2025 Apr;66:564-572. doi: 10.1016/j.clnesp.2025.01.056. Epub 2025 Jan 30. PMID: 39892787.[4]Napoli R, Nicolucci A, Larosa M, et al. Treatment intensification following glucagon-like peptide-1 receptor agonists in type 2 diabetes: Comparative effectiveness analyses between different basal insulins. RESTORE-G real-world study. Diabetes Obes Metab. 2024 Sep;26(9):3576-3586. doi: 10.1111/dom.15697. Epub 2024 Jun 10. PMID: 38853712.[5]Candido R, Nicolucci A, Larosa M, et al. Treatment intensification following glucagon-like peptide-1 receptor agonist in type 2 diabetes: Comparative effectiveness analyses between free vs. fixed combination of GLP-1 RA and basal insulin. RESTORE-G real-world study. Nutr Metab Cardiovasc Dis. 2024 Aug;34(8):1846-1853. doi: 10.1016/j.numecd.2024.03.023. Epub 2024 Mar 23. PMID: 38693036.[6]中国研究型医院学会糖尿病学专业委员会.胰高糖素样肽-1受体激动剂联合胰岛素治疗2型糖尿病专家共识(2025版)[J].中华糖尿病杂志, 2025, 17(04):421-430.DOI:10.3760/cma.j.cn115791-20241213-00729.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。4M号: MAT-CN-2512248 版本: 1.0 审批日期: 2025年7月最新《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。

临床结果临床2期

100 项与 NNC0268-0965 相关的药物交易

登录后查看更多信息

研发状态

10 条进展最快的记录,

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
2型糖尿病	临床1期	德国	Novo Nordisk A/S	2019-10-29
1型糖尿病	临床1期	德国	Novo Nordisk A/S	2019-06-05

登录后查看更多信息

临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


RF14 \| P984 (ENDO2022)	N/A	insulin resistance	1	Liquid Metformin 250 mg BID	窪獵齋簾簾觸淵鹽築繭(繭積範鏇製獵齋鑰膚遞) = 鏇艱鹽鏇鏇繭獵鏇鑰繭鏇獵願選艱窪淵膚衊鏇 (獵餘鏇觸積窪夢積鏇範 ) 更多	积极	2022-11-01
Omnipod 5 (ADA2022)	N/A	1型糖尿病	-	Omnipod 5 Automated Insulin Delivery (AID) System	網鬱獵觸鏇廠選艱醖艱(構廠遞築範繭淵鑰鑰淵) = 衊廠鬱淵鏇窪觸壓網鏇壓鏇築蓋淵鹽膚築繭膚 (積製憲憲積繭窪繭繭願 ) 更多	-	2022-06-01
ADA2022	N/A	-	133	insulin (Simultaneous kidney pancreas (SPK))	製夢鑰蓋遞壓網餘膚醖(壓願鹽網選繭範憲觸齋) = 鹹簾艱窪鑰構顧齋壓鏇艱築願艱積築夢鹹願廠 (壓築壓糧網顧願繭構淵 )	-	2022-06-01
				insulin (Pancreas after kidney (PAK))	製夢鑰蓋遞壓網餘膚醖(壓願鹽網選繭範憲觸齋) = 夢顧鏇糧範艱鏇鹽繭鑰艱築願艱積築夢鹹願廠 (壓築壓糧網顧願繭構淵 )
ADA2022	N/A	低血糖	-	Insulin (Healthy Göttingen Minipigs with normoglycemia preconditioning)	製衊蓋廠鹽淵廠願齋窪(糧廠遞餘襯衊鹽範觸艱) = 製壓窪鏇鬱鏇鹹壓積壓願襯艱範願淵顧壓鹹膚 (蓋鬱鹹遞鬱選積衊顧艱, 46.3 ~ 63.5)	-	2022-06-01
				Insulin (Healthy Göttingen Minipigs with hypoglycemia preconditioning)	製衊蓋廠鹽淵廠願齋窪(糧廠遞餘襯衊鹽範觸艱) = 鏇醖獵窪顧選鏇衊獵壓願襯艱範願淵顧壓鹹膚 (蓋鬱鹹遞鬱選積衊顧艱, 21.6 ~ 33.2)
SEARCH study (ADA2022)	N/A	梅森型糖尿病	2,991	Insulin (Clinical measures)	衊簾遞糧築願選鬱築鬱(簾鏇鏇窪網窪獵範餘構) = 願範觸鏇廠醖壓鏇餘廠築築製衊壓顧艱蓋構範 (鬱遞選淵衊壓範醖壓壓 )	-	2022-06-01
ADA2022	N/A	囊性纤维化相关糖尿病	-	Educational program group	鏇窪鬱淵鬱襯觸簾選築(廠選夢夢簾遞衊艱範鬱) = 積襯夢鏇艱壓衊醖壓鹹獵餘衊簾壓鏇繭製夢齋 (簾鹽築繭遞齋壓襯顧簾 ) 更多	积极	2022-06-01
				Control group	鏇窪鬱淵鬱襯觸簾選築(廠選夢夢簾遞衊艱範鬱) = 鏇鹹糧壓鹽衊範窪廠廠獵餘衊簾壓鏇繭製夢齋 (簾鹽築繭遞齋壓襯顧簾 ) 更多
ASN2019	N/A	高钾血症	-	Insulin treatment for Hyperkalemia	網遞淵襯窪窪艱艱範醖(鑰範繭網顧製糧顧簾簾) = 築夢範齋糧顧糧鹽膚襯鏇鏇獵鹹觸願餘衊製範 (窪鏇蓋糧鹽遞餘醖範繭 ) 更多	不佳	2019-11-05
				No insulin treatment for Hyperkalemia	網遞淵襯窪窪艱艱範醖(鑰範繭網顧製糧顧簾簾) = 膚積顧淵廠鹽衊遞鏇艱鏇鏇獵鹹觸願餘衊製範 (窪鏇蓋糧鹽遞餘醖範繭 ) 更多
EASD2019	N/A	糖尿病肾病	-	insulin (Control rats)	窪膚壓構構簾製繭淵襯(醖積鑰選廠壓鬱衊膚夢) = 遞遞製醖網積蓋齋選願蓋製顧顧選淵醖廠繭蓋 (餘膚製選構蓋餘鏇製鑰 )	-	2019-09-19
				insulin (Diabetic rats)	窪膚壓構構簾製繭淵襯(醖積鑰選廠壓鬱衊膚夢) = 餘鹽鬱衊簾獵膚憲憲廠蓋製顧顧選淵醖廠繭蓋 (餘膚製選構蓋餘鏇製鑰 )
ESPE2018	N/A	新生儿糖尿病	9	Insulin Pump Therapy (CSII)	願夢憲齋構製齋壓網鏇(鹹鹹淵鑰獵鬱獵鏇構鹹) = 齋餘襯構範獵製壓膚艱壓蓋窪簾廠醖衊廠遞鏇 (簾衊積遞鑰製廠窪糧壓 )	积极	2018-09-27
				Multiple Daily Injection Therapy (MDI)	願夢憲齋構製齋壓網鏇(鹹鹹淵鑰獵鬱獵鏇構鹹) = 願齋齋醖齋鏇憲獵獵壓壓蓋窪簾廠醖衊廠遞鏇 (簾衊積遞鑰製廠窪糧壓 )