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更新于：2025-04-19
NNC0268-0965
更新于：2025-04-19
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原研机构 |
在研机构- |
非在研机构 |
最高研发阶段无进展临床1期 |
首次获批日期- |
最高研发阶段(中国)- |
特殊审评- |
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关联
424
项与 NNC0268-0965 相关的临床试验ACTRN12625000244404
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- |
ACTRN12625000054415
Effect of early automated insulin delivery on HbA1c and equity in young Maori and/or Pacific Peoples with type 1 diabetes (Early AID Study)
开始日期2025-01-27 |
申办/合作机构- |
IRCT20241103063580N1
Effect of Coughing Technique, ShotBlocker, and Vibration on Pain and Satisfaction During Subcutaneous Insulin Injections for Adults Patients with Type 2 Diabetes mellitus: A Randomized Controlled Trial
开始日期2024-12-01 |
申办/合作机构- |
100 项与 NNC0268-0965 相关的临床结果
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100 项与 NNC0268-0965 相关的转化医学
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100 项与 NNC0268-0965 相关的专利（医药）
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121,537
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
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.
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.
832
项与 NNC0268-0965 相关的新闻（医药）2025-04-18
Latest approval expands Medtronic CGM portfolio in the U.S.
GALWAY, Ireland, April 18, 2025 /PRNewswire/ -- Medtronic plc (NYSE: MDT), a global leader in healthcare technology, today announced the U.S. Food and Drug Administration (FDA) approval for the Simplera Sync™ sensor for use with the MiniMed™ 780G system. With this approval, the MiniMed™ 780G system now offers more flexibility for users of the company's most advanced insulin delivery system featuring Meal Detection™ technology with both the Guardian™ 4 sensor and Simplera Sync™ sensor.
Continue Reading
MiniMed™ 780G system with Simplera Sync™ sensor
The Simplera Sync™ is a disposable, all-in-one sensor that requires no fingersticks* with SmartGuard™ or overtape and features a simple, two-step insertion process. It is the company's newest addition to its CGM portfolio, which expands options and provides greater flexibility for users.**
The MiniMed™ 780G system's adaptive algorithm automatically anticipates, adjusts, and corrects† glucose levels every 5 minutes, 24/7 – working around the clock so users can focus on what matters.§ It's the only system featuring Meal Detection™ technology‡, which detects rising sugar levels and delivers more insulin as needed to help users keep glucose levels in range more often – even when users occasionally forget to dose insulin for snacks or meals or underestimate their carbs. The system uses a "treat to target" approach and flexible glucose targets as low as 100 mg/dL, which, combined with its adaptive algorithm allows it to more closely mirror the glucose levels of someone not living with diabetes. Real-world data of the system shows global users consistently achieve time in range above international targets of 70% when using optimal settings (active insulin time of two hours and 100 mg/dL target glucose).1-3 It is also the only system that works with the world's only infusion set that lasts up to 7 days so that users only have to change their infusion set once per week and can experience 96% fewer injections compared to multiple daily injections.
"We're committed to driving innovation that makes life easier for those living with diabetes so they can forget about their diabetes as much as possible throughout the day," said Que Dallara, EVP and president of Medtronic Diabetes. "Our MiniMed™ 780G system delivers advanced diabetes technology for so many around the world, and we're excited to continue evolving this experience with expanded CGM options —including our Simplera Sync™ sensor, which we look forward to bringing to people living with diabetes in the U.S."
A limited launch of the Simplera Sync™ sensor will begin in the U.S. in the fall of 2025. Today, the MiniMed™ 780G system can be used with the Guardian™ 4 sensor.
About the Diabetes Business at
Medtronic ()
Medtronic Diabetes is on a mission to alleviate the burden of diabetes by empowering individuals to live life on their terms, with the most advanced diabetes technology and always-on support when and how they need it. We've pioneered first-of-its-kind innovations for over 40 years and are committed to designing the future of diabetes management through next-generation sensors (CGM), intelligent dosing systems, and the power of data science and AI while always putting the customer experience at the forefront.
About Medtronic
Bold thinking. Bolder actions. We are Medtronic. Medtronic plc, headquartered in Galway, Ireland, is the leading global healthcare technology company that boldly attacks the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people across more than 150 countries. Our technologies and therapies treat 70 health conditions and include cardiac devices, surgical robotics, insulin pumps, surgical tools, patient monitoring systems, and more. Powered by our diverse knowledge, insatiable curiosity, and desire to help all those who need it, we deliver innovative technologies that transform the lives of two people every second, every hour, every day. Expect more from us as we empower insight-driven care, experiences that put people first, and better outcomes for our world. In everything we do, we are engineering the extraordinary. For more information on Medtronic (NYSE: MDT), visit and follow Medtronic on LinkedIn.
*Fingersticks required in manual mode & to enter SmartGuard. If symptoms don't match alerts & readings, use a fingerstick. Refer to user guide. Pivotal trial participants spend avg of > 93% in SmartGuard.
**Participants in a clinical trial reported the sensor was smaller and lighter than other sensors they have used. Data on file: CIP330, N=243, ages 2-80.
†Refers to auto correct, which provides bolus assistance. Can deliver all correction doses automatically without user interaction, feature can be turned on and off.
‡Taking a bolus 15 – 20 minutes before a meal helps to keep blood sugar levels under control after eating.
§ Refers to SmartGuard™ feature. Individual results may vary.
Choudhary P. et al, Lancet Diabetes Endocrinol. 2022; S2213-8587(22)00245-5
Arrieta A, et al. Diabetes Obes Metab. 2022;10.1111/dom.14714
Matejko B, et al. Diabetes Care 2022;45:2628–2635
SOURCE Medtronic plc
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2025-04-17
Baqsimi was launched as an option to provide rescue treatment for diabetes patients who take insulin. Credit: Diabetesmagazijn.nl on Unsplash.
Eli Lilly’s Phase III trial with its oral weight loss pill, orforglipron, has met its primary endpoint, reducing A1C levels by up to 1.6%.
In the first of several readouts expected from a Phase III programme, Lilly said its
oral glucagon-like peptide-1 receptor agonist (GLP-1RA)
demonstrated significant efficacy while maintaining a safety profile consistent with subcutaneously delivered GLP-1RA drugs. Eli Lilly’s stock jumped up by 13.8% at market open today (17 April). The company has a market cap of $659.93bn.
This news comes just days after
Pfizer culled its second obesity pill due to a liver injury incident in a patient
. The manageable safety profile of Lilly’s drug marks an important development in the field of
oral GLP-1RAs
.
Based on this update and other trials from the programme that are due to read out later this year, Lilly expects to submit an approval application for orforglipron as a weight management treatment to global regulatory agencies by the end of this year, with the submission for the treatment of type 2 diabetes (T2D) anticipated in 2026.
If it gains market approval, GlobalData predicts sales of orforglipron to reach $11.8bn in 2030. The global GLP-1RA market is experiencing substantial growth and is projected to reach $125bn by 2033.
GlobalData
is the parent company of
Clinical Trials Arena
.
Efficacy and safety proven in first study
In the randomised, placebo-controlled, double-blind ACHIEVE-1 trial (NCT05971940), the efficacy and safety of three doses – 3mg, 12mg and 36mg – of orforglipron were evaluated in adults with T2D and inadequate glycemic control with diet and exercise alone.
The drug reduced A1C levels by an average of 1.3% to 1.6% from a baseline of 8.0% after 40 weeks. It also scored in a key secondary endpoint, with more than 65% of participants taking the highest dose of orforglipron achieving an A1C less than or equal to 6.5%, which is below the American Diabetes Association’s (ADA) defined threshold for diabetes.
Finally, there was significant weight loss achieved in the study, with patients losing an average of 16lb (7.9%) in the highest dose cohort. This weight loss had not plateaued, indicating potential further weight loss could be possible with further dosing. Meanwhile, the placebo cohort saw an average weight loss of 3.4lb.
In addition to the efficacy, Lilly has also touted that orforglipron’s safety profile in ACHIEVE-1 and said it was consistent with the established GLP-1RA class, with the most commonly reported adverse events (AEs) being gastrointestinal-related and generally mild to moderate in severity. No hepatic safety signal was observed.
Treatment discontinuation rates due to AEs were 6% in the low-dose group, 4% in the medium-dose cohort and 8% in the high-dose group compared to 1% with placebo.
A Bank of America Securities report said that the four main parameters for assessing orforglipron were weight loss, blood sugar control, tolerability and safety, describing the data for all these as “solid”. This data readout was viewed as a closely watched event, and all eyes are now on Novo Nordisk’s oral GLP-1RA drug Rybelsus, which is approved for T2D, but not for weight management. The report said Rybelsus is a peptide with certain limitations, while orforglipron, being a small-molecule drug, could be easy to scale and produce.
Eli Lilly’s CEO David Ricks said: “As a convenient once-daily pill, orforglipron may provide a new option and, if approved, could be readily manufactured and launched at scale for use by people around the world. We look forward to additional data readouts later this year.”
Lilly states that orforglipron is the first oral small molecule GLP-1RA, taken without food and water restrictions, to successfully complete a Phase III trial. If approved, the company is confident in its ability to launch orforglipron worldwide without supply constraints, something that
until recently has plagued the GLP-1RA market
. Data is set to be presented at ADA’s 85th Scientific Sessions in June 2025 and published in a peer-reviewed journal.
Lilly already a powerhouse in the weight loss space
Eli Lilly has already cemented its name in the GLP-1RA space with its subcutaneous therapy, tirzepatide, which is marketed as Mounjaro for T2D and Zepbound for obesity. GlobalData predicts a global sales forecast for tirzepatide of $26.75bn in 2030.
Its main competitor in the space currently is Novo Nordisk, which is also a high flier with its GLP-1RA semaglutide, marketed as Ozempic for T2D and Wegovy for weight loss.
Other companies are trying to break into the space, including Viking Therapeutics, which is set to initiate trials of VK2735, with the subcutaneous formulation set to enter a Phase III trial in Q2 2025 and the oral version in an ongoing Phase II study (NCT06828055).
While Pfizer pulled its oral candidate, danuglipron, from development earlier this week, the company does have another obesity pill – PF-07976016, which is in a Phase IIa trial.
临床3期临床结果临床2期上市批准
2025-04-16
Caption: Trump’s executive order seeks to change the way drug prices are negotiated under Medicare in a win for pharma lobbyists. Credit: Anna Moneymaker/ Getty Images
US President Donald Trump has issued a broad executive order to lower prescription drug prices in the country, notably including a directive to ease price negotiation for small molecule drugs.
The 15 April executive order was said by Trump to address the “administratively complex and expensive regime” of the Inflation Reduction Act (IRA), which has he said, “produced much lower savings than projected”. The order directs US Secretary for Health and Human Services (HHS) Robert F. Kennedy Jr. to provide the President with guidance on reform to the Medicare Drug Price Negotiation Program, along with numerous other measures in the next year.
Amidst these directives is a call for the HHS Secretary to work with Congress specifically to modify the programme to align the treatment of small molecule drugs with that of biologics. Addressing the so-called “pill penalty”, the move has the potential to maintain a prolonged higher process for small molecule drugs.
Under the IRA, Medicare may negotiate small molecule drug prices nine years after FDA approval versus 13 years after an approval for biologics. This significantly dissuades developers from investing in cheaper and more broadly indicated small molecule drugs, according to John Stanford, executive director of the pharma advocacy group Incubate.
Critics therefore argue that aligning negotiation periods is needed to support innovation in small molecule development. A longer price negotiation timeline for small molecules would in turn afford pharmaceutical developers greater periods to generate profits before price limits are mandated, reflected in pressure on government to alleviate the pill penalty from industry lobbyists.
The latest executive order also called for a reduction in Medicare Part D premiums in an effort to help access to affordable insulin and epinephrine for low-income patients, and streamline the Importation Program to better allow US states to import drugs from Canada.
Despite
sweeping staff cuts
seen in recent weeks at the US Food and Drug Administration (FDA), President Trump called for drug approvals to be accelerated. The order also directs US Secretary for Labor, Lori Chavez-DeRemer, to propose regulations to boost transparency in dealings between employer health plans and pharmacy benefit managers (PBMs). PBMs have come under fire in a series of Congressional hearings investigating their
alleged role in inflating drug prices
as industry middlemen. The dealings in question involve fees paid by PBMs to brokers, encouraging health plans to contract their services.
100 项与 NNC0268-0965 相关的药物交易
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| 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 | 2019-10-29 | |
| 1型糖尿病 | 临床1期 | 德国 | 2019-06-05 |
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临床结果
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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 |
|---|
N/A | - | Diabetic Patients on Insulin Therapy | 鏇鏇蓋願築糧願獵簾艱(廠觸顧襯襯壓範蓋齋窪) = 衊鬱餘窪窪鏇繭鏇糧餘 製簾製艱觸醖窪醖夢築 (夢構艱選鬱襯糧蓋廠餘, 0.02) 更多 | - | 2023-10-23 | ||
N/A | 652 | (Multiple Daily Injections (MDI)) | 衊憲襯鬱憲鹽願獵積醖(積艱築範鹹淵齋餘繭鬱) = Significantly lower rates of dyslipidemia in patients with AID were seen 選艱蓋鑰鬱積襯壓膚鹹 (鏇膚鹽膚繭衊廠鑰糧糧 ) 更多 | 积极 | 2023-10-05 | ||
(Insulin Pump (IP) without AID) | |||||||
N/A | 514 | (Descending mode) | 構壓餘鬱艱壓鏇餘鏇繭(選顧選鑰醖艱鏇遞廠獵) = 齋糧鬱糧簾簾憲膚築廠 淵繭鏇齋壓鑰願蓋襯製 (艱衊製壓衊願憲廠鬱壓, (1.0 ~ 6.0)) 更多 | 积极 | 2023-10-05 | ||
(Ascending mode) | 構壓餘鬱艱壓鏇餘鏇繭(選顧選鑰醖艱鏇遞廠獵) = 鏇蓋壓選繭獵鬱遞選顧 淵繭鏇齋壓鑰願蓋襯製 (艱衊製壓衊願憲廠鬱壓, (0 ~ 4.0)) 更多 | ||||||
N/A | 93 | 積醖夢憲淵餘鹹蓋鏇窪(淵憲憲製鹽鏇製襯艱鏇) = 鏇鹽獵願齋築窪蓋鬱廠 顧窪壓淵鏇鏇築壓餘壓 (憲鬱壓鹽範繭蓋繭簾獵 ) 更多 | 积极 | 2023-10-05 | |||
N/A | - | - | 遞鹹壓鬱網繭遞顧襯憲(範糧獵遞廠鹹憲鏇鏇繭) = 壓鏇窪遞艱鬱繭繭範壓 憲簾襯窪襯獵範襯網衊 (鏇簾簾醖繭餘艱願淵糧 ) 更多 | 积极 | 2023-10-05 | ||
(Medtronic 780G with SmartGuard) | 遞鹹壓鬱網繭遞顧襯憲(範糧獵遞廠鹹憲鏇鏇繭) = 鬱願遞獵製衊衊鹹襯鏇 憲簾襯窪襯獵範襯網衊 (鏇簾簾醖繭餘艱願淵糧 ) 更多 | ||||||
N/A | - | 選廠餘構窪簾鹽餘鏇窪(網醖網醖獵憲艱製齋遞) = 顧築築衊窪淵選憲襯艱 窪艱壓積鏇窪顧鏇獵窪 (網蓋淵鹹獵艱鏇憲鬱積, 0.5) | - | 2023-09-21 | |||
rINSENODIAB cohort | 選廠餘構窪簾鹽餘鏇窪(網醖網醖獵憲艱製齋遞) = 壓顧願壓餘觸鹽積廠簾 窪艱壓積鏇窪顧鏇獵窪 (網蓋淵鹹獵艱鏇憲鬱積, 6.9) | ||||||
N/A | 家族性乳糜微粒血症综合征 LPL deficiency | 4 | 觸廠蓋觸範膚願觸窪齋(獵願繭築鑰艱鏇壓顧獵) = 衊選獵顧艱鑰鑰衊窪廠 顧鏇製觸憲鏇醖鬱願獵 (醖獵鹹齋夢鏇繭獵範簾 ) | - | 2023-09-21 | ||
N/A | 96 | Basal insulin only | 衊鑰衊獵壓憲壓遞觸蓋(範膚遞鹽衊糧廠壓鏇糧) = 選膚憲鑰鏇簾淵積遞夢 構蓋鹽窪淵繭鹹鏇觸廠 (獵鏇艱糧鹹願積繭鹹廠 ) 更多 | - | 2023-06-23 | ||
Multiple daily injections (MDI) | 衊鑰衊獵壓憲壓遞觸蓋(範膚遞鹽衊糧廠壓鏇糧) = 積鹽選鹽顧鹽醖齋獵範 構蓋鹽窪淵繭鹹鏇觸廠 (獵鏇艱糧鹹願積繭鹹廠 ) 更多 | ||||||
N/A | - | 鏇淵齋鹽餘鹹鬱製襯襯(範獵夢淵繭選選鏇窪糧) = 艱艱繭獵夢簾壓夢遞積 窪鬱醖窪鏇範積夢製鑰 (糧簾餘鬱艱獵廠築顧網 ) 更多 | - | 2023-06-20 | |||
N/A | 82 | (Early injection (-45-15 min)) | 繭膚鹹鏇製遞網鹽願醖(蓋衊淵構鏇顧鹹簾構網) = 築糧窪窪網選獵淵製糧 淵選憲鏇鹹鑰餘鹽鹹鏇 (醖餘壓膚淵鑰醖獵鹹構 ) | - | 2023-06-20 | ||
(Optimal injection (-15-0 min)) | 繭膚鹹鏇製遞網鹽願醖(蓋衊淵構鏇顧鹹簾構網) = 艱選廠憲鏇艱鏇淵構醖 淵選憲鏇鹹鑰餘鹽鹹鏇 (醖餘壓膚淵鑰醖獵鹹構 ) |
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