A Clinical Study to Evaluate the Pharmacokinetic and Pharmacodynamics Properties of of SHR-3167 Injection at Steady State in Subjects With Type 2 Diabetes

The objective of this study is to evaluate the pharmacokinetics and pharmacodynamics of SHR-3167 at steady state in subjects with type 2 diabetes.

开始日期2025-08-11

申办/合作机构

江苏恒瑞医药股份有限公司

ChiCTR2500105275

/ Not yet recruiting临床4期

Clinical Study Insulin Degludec and Liraglutide Injection of in the Treatment of Obese Type 2 diabetes with Poor Blood Glucose Control

开始日期2025-07-01

申办/合作机构-

ChiCTR2500105623

/ Not yet recruiting临床1期IIT

A phase I clinical trial evaluating the pharmacokinetics, pharmacodynamics and safety of multiple-dose SHR-3167 injection in type 2 diabetic subjects at steady state.

开始日期2025-06-30

申办/合作机构

江苏恒瑞医药股份有限公司

100 项与德谷胰岛素相关的临床结果

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100 项与德谷胰岛素相关的转化医学

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100 项与德谷胰岛素相关的专利（医药）

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941

项与德谷胰岛素相关的文献（医药）

2025-12-31·JOURNAL OF MEDICAL ECONOMICS

Cost-effectiveness of insulin icodec for the treatment of type 2 diabetes in Canada

Article

作者: Mau, Godfrey ; Garcia, David A. ; Singh, Sumeet ; Spence, Michaela ; Goldenberg, Ronald ; Jensen, Morten Sall

AIM:

Patients with type 2 diabetes (T2D) with poor glycemic control despite use of non-insulin agents can experience delay in initiating insulin therapy and poor adherence to insulin therapy, predominantly due to the burden of multiple injections^1-3. This study aimed to determine the cost-effectiveness of insulin icodec, first once-weekly basal insulin, compared with long-acting basal insulins for improving glycemic control in adults with T2D in Canada.

MATERIALS AND METHODS:

The Swedish Institute of Health Economics T2D Cohort Model was used to analyse three T2D groups: insulin naïve (IN), basal insulin experienced (BIE), and basal-bolus insulin experienced (BBIE). Comparators included insulin glargine, insulin detemir, and insulin degludec. Comparative efficacy was informed by the phase 3 ONWARDS trials of insulin icodec and network meta-analyses (NMA). Time horizon was 40 years. Analyses considered disutilities resulting from vascular complications, age, gender, diabetes duration, hypoglycemia, and injection burden. A 1.5% annual discount rate was used for costs and effects. The average cost per unit for each treatment, accounting for the market share of available formats and biosimilars was calculated. Outcomes were expressed as quality-adjusted life-years (QALYs) and cost-effectiveness as incremental cost utility ratios (ICUR [cost/QALY]).

RESULTS:

In all analyses, insulin icodec dominated insulin degludec and insulin detemir. Compared to insulin glargine U100 and U300, insulin icodec was associated with ICURs of $17,876, $20,844, and $73,253; and $6,439, $8,623, and $45,433 in the IN, BIE, and BBIE populations, respectively.

LIMITATIONS:

Limitations of this economic evaluation include the lack of data for some treatments in certain NMAs, uncertainty regarding the use of the NMA results for a 40-year time horizon, heterogeneous sources of disutilities, and uncertainty regarding the HRQoL benefits of reduced injection frequency.

CONCLUSIONS:

Insulin icodec is a cost-effective treatment option for adult patients with T2D versus once daily basal insulin-analogues publicly reimbursed in Canada.

2025-10-01·JOURNAL OF DIABETES AND ITS COMPLICATIONS

Degludec insulin versus efsitora insulin in diabetes mellitus management: A systematic review and meta-analysis

Review

作者: Gallo Ruelas, Mariano ; Flávio-Reis, Victor Hugo Palhares ; Queiroz, Ivo ; Barbosa, Lucas Mendes ; de Oliveira, Helen Michaela ; Zamora, Fernanda Valeriano ; Cavalcante, Deivyd Vieira Silva

PURPOSE:

To compare the efficacy and safety of next-generation basal insulin efsitora versus insulin degludec in managing type 1 and type 2 diabetes.

METHODS:

We systematically searched PubMed, Embase, and CENTRAL databases until October 2024. This study followed PRISMA guidelines. Statistical analyses were performed using R version 4.4.1. The risk of bias was assessed using the RoB2 tool, and the quality of evidence was evaluated using the GRADE approach. This study was registered in PROSPERO under protocol CRD42024597806.

RESULTS:

Six randomized controlled trials involving 2590 patients were included in the analysis. Of these, 1376 (53.13 %) received efsitora insulin. No significant differences were observed between efsitora and degludec in glycemic efficacy outcomes, including HbA1c reduction, fasting blood glucose, weight change, and proportion of patients achieving HbA1c <7 %. Regarding safety outcomes, most endpoints, such as adverse events, injection site reactions, hypersensitivity, severe hypoglycemia, and mortality, were comparable between groups, with no significant subgroup effects. However, subgroup analysis revealed a lower incidence of nocturnal hypoglycemia with efsitora in patients with type 2 diabetes, and a higher rate of serious adverse events in patients with type 1 diabetes, suggesting potential population-specific differences in safety profiles.

CONCLUSION:

Efsitora and degludec insulins show similar overall efficacy and safety in the management of diabetes. However, subgroup analyses indicate that patient-specific factors, such as diabetes type, may influence the risk of certain adverse events. These findings support the importance of individualized insulin selection based on patient characteristics and risk profiles.

2025-09-01·DIABETOLOGIA

Insulin DEgludec/LIraglutide versus multiple daily insulin injections in the transition from hospital to outpatient management assessed by continuous glucose monitoring: the DELI transition trial

Article

作者: Gómez-Medina, Ana M ; Pertuz-Noriega, Carlos E ; Gómez-Quesada, Yaline ; Villamil-Castañeda, Lina P ; Muñoz-Velandia, Oscar M ; Chaim, Salma N ; Aschner, Pablo ; Yepes, Carlos A ; Henao-Carillo, Diana C

Abstract:

Aims/objective:

The aim of the study was to assess the safety profile (defined as the percentage of patients with at least one hypoglycaemic event [more than 15 min with glucose levels <3.0 mmol/l as documented by continuous glucose monitoring] in the first 4 weeks of follow-up) for insulin degludec/liraglutide (IDegLira) compared with multiple daily insulin injections (MDI) during the transition from hospital to an outpatient setting.

Methods:

The study was an open-label, randomised, controlled clinical trial comparing IDegLira to MDI after hospital discharge in patients with type 2 diabetes. The study evaluated the percentage of patients with at least one hypoglycaemic event, the hypoglycaemia event density, the time in range (TIR 3.8–10 mmol/l), the time below range (TBR <3.0 or <3.8 mmol/l), and other glycaemic management metrics measured by continuous glucose monitoring.

Results:

Sixty-four patients were included in the analysis (32 in each group). They had a baseline HbA1c of 103 ± 11.6 mmol/mol (11.6 ± 1.7%) and age of 58 ± 12.4 years (means ± SD). The proportion of patients with at least one hypoglycaemic event (plasma glucose <3.0 mmol/l) was lower in the IDegLira group than in the MDI group (6.2% vs 31.3%; p<0.010), as was the hypoglycaemia event density (incidence rate ratio 15.2; 95% CI 6.2, 48.2; p<0.001), TBR <3.8 mmol/l (0.9% vs 2.9%; p=0.019) and TBR <3.0 mmol/l (0.6% vs 1.3%, p=0.008). The TIR 3.8–10 mmol/l was higher in the IDegLira group (80.6% vs 69.7%; p=0.008). The findings were consistent regardless of baseline HbA1c.

Conclusions/interpretation:

IDegLira proved to be safer and more effective than MDI for individuals with type 2 diabetes who had suboptimal glycaemic control, aiding in their transition from hospital to outpatient care.

Trial registration:

Clinicaltrials.gov NCT05767255

Funding:

This research was funded by a grant from the Asociación Colombiana de Endocrinología, Diabetes y Metabolismo (ACE).

Graphical Abstract:

220

项与德谷胰岛素相关的新闻（医药）

2025-09-30

·EINPresswire

April - June 2025 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)

Acetaminophen-containing products Anaphylactic reaction FDA is evaluating the need for regulatory action. Aptryxol (desvenlafaxine) DaTscan (ioflupane I 123 injection) Desvenlafaxine extended-release tablets Effexor XR (venlafaxine extended-release) capsules Pristiq (desvenlafaxine) extended-release tablets Venlafaxine (venlafaxine hydrochloride) extended-release tablets False positive radioisotope investigation test result potentially secondary to a drug interaction with venlafaxine FDA is evaluating the need for regulatory action. Barium sulfate-containing products Entero Vu 24% (barium sulfate) oral suspension E-Z-Disk (barium sulfate) tablets Liquid E-Z-Paque (barium sulfate) oral suspension Readi-Cat 2 (barium sulfate) oral suspension Readi-Cat 2 Smoothie (barium sulfate) oral suspension Taglitol V (barium sulfate) oral suspension Varibar Honey (barium sulfate) oral suspension Varibar Nectar (barium sulfate) oral suspension Varibar Pudding (barium sulfate) oral paste Varibar Thin Honey (barium sulfate) oral suspension Varibar Thin Liquid (barium sulfate) oral suspension Anaphylactic reaction FDA is evaluating the need for regulatory action. 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Example: Briumvi labeling Briumvi (ublituximab-xiiy) injection Kesimpta (ofatumumab) injection Ocrevus (ocrelizumab) injection Ocrevus Zunovo (ocrelizumab and hyaluronidase-ocsq) injection Central nervous system infection FDA is evaluating the need for regulatory action. Crexont (carbidopa and levodopa) extended-release capsules Dhivy (carbidopa and levodopa) tablets Duopa (carbidopa and levodopa) enteral suspension Rytary (carbidopa and levodopa) extended-release capsules Sinemet (carbidopa and levodopa) tablets Sinemet CR (carbidopa and levodopa) sustained-release tablets Stalevo (carbidopa, levodopa and entacapone) tablets Vyalev (foscarbidopa and foslevodopa) injection Seizure FDA is evaluating the need for regulatory action. Crysvita (burosumab-twza) injection Hypercalcemia The "Dosage and Administration", "Warnings and Precautions" and "Adverse Reactions" sections of the labeling were updated in August 2025 to include information about hypercalcemia. 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Glucagon-like peptide-1 (GLP-1) receptor agonists Adlyxin (lixisenatide) injection Bydureon (exenatide) for extended-release injectable suspension Bydureon BCise (exenatide extended-release) injectable suspension Byetta (exenatide) injection Mounjaro (tirzepatide) injection Ozempic (semaglutide) injection Rybelsus (semaglutide) tablets Saxenda (liraglutide) injection Soliqua 100/33 (insulin glargine and lixisenatide) injection Trulicity (dulaglutide) injection Victoza (liraglutide) injection Wegovy (semaglutide) injection Xultophy 100/3.6 (insulin degludec and liraglutide) injection Zepbound (tirzepatide) injection Intestinal obstruction and fecal impaction FDA is evaluating the need for regulatory action. Imbruvica (ibrutinib) capsules; tablets; oral suspension Nail and nail bed conditions (excluding infections and infestations) FDA is evaluating the need for regulatory action. MEK inhibitors Avmapki Fakzynja Co-pack (avutometinib capsules; defactinib tablets) Cotellic (cobimetinib) tablets Mekinist (trametinib) tablets; oral solution Mektovi (binimetinib) tablets Koselugo (selumetinib) capsules Gingival hypertrophy FDA is evaluating the need for regulatory action. Neffy (epinephrine nasal spray) Product storage error FDA is evaluating the need for regulatory action. Nurtec ODT (rimegepant) orally disintegrating tablets Zavzpret (zavegepant) nasal spray Anaphylactic reaction The "Contraindications" and "Warnings and Precautions" sections of the labeling were updated in August 2025 to include information about hypersensitivity reactions, including anaphylaxis. Example: Nurtec ODT labeling Rozlytrek (entrectinib) capsules; oral pellets Brugada syndrome FDA is evaluating the need for regulatory action. Sodium-glucose cotransporter-2 (SGLT2) inhibitors Fournier's gangrene FDA is evaluating the need for regulatory action. Teriparatide injection (a particular generic product) Device malfunction FDA is evaluating the need for regulatory action. Vizamyl (flutemetamol F18 injection) Anaphylactic reaction The "Warnings and Precautions" section of the labeling was updated in June 2025 to include information about anaphylaxis and other serious hypersensitivity reactions. Vizamyl labeling Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

上市批准生物类似药

2025-09-29

·PRNewswire

Novo Nordisk resubmits Awiqli® to the FDA with potential to be the first once-weekly basal insulin treatment for adults with type 2 diabetes

Awiqli® (insulin icodec) injection, if approved, has the potential to be the first once-weekly basal insulin treatment available in the US for adult type 2 diabetes In adults with type 2 diabetes, the ONWARDS clinical trial program evaluated the change in A1C from baseline with Awiqli® compared to daily basal insulin1-5 Resubmission reflects Novo Nordisk's 100-year legacy of advancing diabetes care BAGSVÆRD, Denmark and PLAINSBORO, N.J., Sept. 29, 2025 /PRNewswire/ -- Novo Nordisk today announced the resubmission of its Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for Awiqli® (insulin icodec) injection, a once-weekly basal insulin treatment for adults living with type 2 diabetes. If approved, Awiqli® would become the first once-weekly basal insulin available in the United States, providing an alternative to daily basal insulin injections for adults living with type 2 diabetes. "With this resubmission, we're closer to offering a new insulin treatment option for people living with type 2 diabetes that, if approved, could reduce their yearly basal insulin injections from 365 to 52," said Anna Windle, PhD, Senior Vice President, Clinical Development, Medical and Regulatory Affairs at Novo Nordisk. "It is critical that we continue to build upon our 100-year legacy in diabetes and long-standing mission to advance science and the ONWARDS clinical program supports our hope that Awiqli® can help streamline the basal insulin injection regimen for people living with type 2 diabetes." The resubmission is based on results from the ONWARDS type 2 diabetes phase 3a program for once-weekly Awiqli® which is comprised of five randomized, active-controlled, treat-to-target clinical trials in approximately 4,000 adults with type 2 diabetes. The clinical program evaluated Awiqli® vs. daily basal insulin and the primary endpoint in these trials was change in A1C from baseline.1-5 About Awiqli® In the US, Awiqli® is an investigational, novel once-weekly basal insulin analog designed to cover the basal insulin requirements for a full week with a single subcutaneous injection. This resubmission is in response to the FDA's action letter received in Q3 2024. Awiqli® is approved in the EU, along with 12 additional countries. In addition, regulatory filings have been completed in several other countries, with further regulatory decisions expected in 2025. About Novo Nordisk Novo Nordisk is a leading global healthcare company founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat serious chronic diseases built upon our heritage in diabetes. We do so by pioneering scientific breakthroughs, expanding access to our medicines, and working to prevent and ultimately cure disease. Novo Nordisk employs about 78,400 people in 80 countries and markets its products in around 170 countries. For more information, visit novonordisk.com, Facebook, Instagram, X, LinkedIn and YouTube. Contacts for further information References Rosenstock J, Bain C. S, Gowda A, et al. Weekly Icodec versus Daily Glargine U100 in Type 2 Diabetes without Previous Insulin. The New England Journal of Medicine. 2023 10.1056/NEJMoa2303208 Philis-Tsimikas A, Asong M, Franek E, et al. Switching to once-weekly insulin icodec versus once-daily insulin degludec in individuals with basal insulin-treated type 2 diabetes (ONWARDS 2): a phase 3a, randomised, open label, multicentre, treat-to-target trial. Lancet Diabetes Endocrinol. 2023 (23)00093-1 Lingvay I, Asong M, Desouza C, et al. Once-Weekly Insulin Icodec vs Once-Daily Insulin Degludec in Adults With Insulin-Naive Type 2 Diabetes The ONWARDS 3 Randomized Clinical Trial. JAMA. 2023 Mathieu C, Ásbjörnsdóttir B, Bajaj H, et al. Switching to once-weekly insulin icodec versus once-daily insulin glargine U100 in individuals with basal-bolus insulin-treated type 2 diabetes (ONWARDS 4): a phase 3a, randomised, open-label, multicentre, treat-to-target, non-inferiority trial. 2023 (23)00520-2 Bajaj H, Aberle J, Davies M, et al. Once-Weekly Insulin Icodec With Dosing Guide App Versus Once-Daily Basal Insulin Analogues in Insulin-Naïve Type 2 Diabetes (ONWARDS 5). Annals of Internal Medicine. 2023 10.7326/M23-1288 Novo Nordisk is a registered trademark of Novo Nordisk A/S. © 2025 Novo Nordisk All rights reserved. US25AWQ00001. September 2025 SOURCE Novo Nordisk WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

临床3期上市批准临床2期

2025-09-29

·恒瑞医药

恒瑞医药新型长效胰岛素类似物舒地胰岛素（INS068）两项降糖III期研究亮相EASD简短口头报告

中欧夏令时间（CEST）2025年9月15至19日，第61届欧洲糖尿病研究协会（EASD）年会在奥地利维也纳举办。期间，恒瑞医药自主研发的新型长效胰岛素类似物舒地胰岛素（INS068）治疗成人2型糖尿病（T2DM）患者的两项关键III期临床试验（INS068-301和INS068-302）分别以简单口头报告形式精彩亮相。 INS068-301研究由复旦大学附属中山医院李小英教授作为主要研究者，带领全国56家中心共同参与完成。INS068-302研究由北京大学人民医院纪立农教授作为主要研究者，带领全国68家中心共同参与完成。两项研究结果表明，在口服降糖药控制不佳或基础胰岛素控制不佳的T2DM患者中，舒地胰岛素在血糖控制方面显示出与甘精胰岛素相当的疗效，且夜间低血糖风险明显降低[1]。本文详细介绍两项关键III期临床试验的研究设计、研究结果及在T2DM人群中的潜在应用前景。 2025 EASD现场图：北京大学人民医院高蕾莉教授就INS068-302研究做口头报告 2025 EASD现场图：恒瑞医药陈虹博士就INS068-301研究做口头报告 -- 研究背景和目的 T2DM是⼀种慢性进展性疾病，随着病程发展，常需要联合两种或两种以上降糖药物以维持血糖控制。基础胰岛素是T2DM治疗的重要手段，但低血糖风险，尤其是夜间低血糖，是其临床应用中的主要挑战。舒地胰岛素是⼀种新型的可溶性长效胰岛素类似物，每日⼀次皮下注射给药。药物半衰期约为21小时，在稳态下正葡萄糖钳夹试验中降糖效果可持续超过42小时[2]。 INS068-301与INS068-302为两项随机、开放标签、平行对照设计的III期临床研究，分别纳入基础胰岛素经治后血糖控制不佳以及口服降糖药经治后血糖控制不佳的T2DM患者，进行舒地胰岛素与甘精胰岛素的头对头对比。两项研究的目的为评估舒地胰岛素在中国T2DM患者中的疗效与安全性，本报告对两项研究的关键数据进行汇总呈现。 INS068-301研究：舒地胰岛素（INS068）与甘精胰岛素在基础胰岛素控制不佳的T2DM患者中的疗效和安全性比较 01 研究设计研究纳入已接受基础胰岛素治疗≥8周，糖化血红蛋白（HbA1c）7.0%-10.0%的成年T2DM患者。符合纳入标准的受试者按1:1比例随机分组，接受INS068或甘精胰岛素（IGlar）每日一次（QD）皮下注射治疗。胰岛素起始剂量根据患者此前使用的基础胰岛素剂量进行换算，治疗期间进行剂量滴定（目标血糖：早餐前自我监测指尖血糖 3.9~5.6mmol/L）。本研究的主要终点指标为治疗第26周HbA1c相对基线变化，采用非劣效性检验进行统计分析，设定非劣效界值为0.4%。图1：INS068-301研究设计（ClinicalTrials.gov, NCT05702073） 02 研究结果 1 基线特征研究共入组423例中国成人T2DM受试者，INS068组和IGlar组分别入组211例和212例。两组受试者人口学和其他基线特征相似，具有可比性。INS068组和IGlar组中，平均年龄分别为58.3岁和58.5岁，男性占比分别为62.1%和55.7%，平均BMI分别为24.78 kg/m2和24.83 kg/m2，平均HbA1c分别为8.30%和8.36%，平均空腹血糖（FPG）分别为8.34 mmol/L和8.51 mmol/L，基础胰岛素的平均日剂量分别为16.1 U和16.6 U。表1：INS068-301研究基线特征 2 降糖疗效本研究达到预设的主要终点，治疗26周后，INS068组的HbA1c相对基线变化非劣于IGlar组。INS068组与IGlar组的HbA1c降幅分别为0.70%和0.83%，两组差值为 0.13%（95% CI：-0.05，0.31）。图2：INS068-301研究主要终点：治疗第26周HbA1c相对基线变化治疗26周后，INS068组FPG降幅大于IGlar组（均值变化：-2.40 mmol/L vs -1.96 mmol/L；两组差值：-0.45 mmol/L，95% CI：-0.74，-0.16）。图3：INS068-301次要终点：26周时FPG较基线的变化两组受试者在接受治疗12周后，早餐前自我监测血糖（SMPG）趋于稳定，且两组各访视前三天的早餐前SMPG均值基本一致。治疗第26周，INS068组与IGlar组的每日胰岛素剂量分别为 0.46 U/kg和0.48 U/kg。 3 安全性研究期间，INS068组和IGlar组治疗期间出现的不良事件（AE）和治疗相关AE的发生率均相当。INS068组和IGlar组的SAE发生率相当，且均与治疗无关。研究期间未发生导致治疗提前终止、暂停用药的AE。与IGlar组相比，INS068组的总低血糖发生率在数值上低于IGlar组（两组发生率分别为48.6% vs 53.8%，风险比0.90 [0.75, 1.09]），且夜间总低血糖风险低于IGlar组（两组发生率分别为21.9% vs 33.5%，风险比0.65 [0.48, 0.90]）。 INS068-302研究：舒地胰岛素（INS068）与甘精胰岛素在口服降糖药控制不佳的T2DM患者中的疗效及安全性比较 01 研究设计研究纳入已接受稳定剂量口服降糖药（OADs）治疗≥8周，HbA1c 7.0%-11.0%的成年T2DM患者。符合纳入标准的患者按2:1比例随机分组，分别接受INS068或IGlar每日一次（QD）皮下注射治疗。胰岛素起始剂量为每日10 U，治疗期间进行剂量滴定（目标血糖：早餐前自我监测指尖血糖3.9~5.6 mmol/L）。研究的主要终点指标为治疗第26周HbA1c相对基线变化，采用非劣效性检验进行统计分析，设定非劣效界值为0.4%。图4：INS068-302研究设计（ClinicalTrials.gov, NCT05699408） 02 研究结果 1 基线特征研究共入组513例中国成人T2DM受试者，INS068组和IGlar组分别入组341例和172例。两组受试者人口学和其他基线特征相似，具有可比性。INS068组和IGlar组中，平均年龄分别为56.7岁和55.7岁，男性占比分别为60.1%和64.0%，平均BMI分别为24.9kg/m2和25.0 kg/m2，平均HbA1c分别为8.44%和8.47%，FPG分别为9.32 mmol/L和9.36 mmol/L。表2：INS068-302研究基线特征 2 降糖疗效本研究达到预设的主要终点，治疗26周后，INS068组的HbA1c相对基线变化非劣于IGlar组。INS068 组与 IGlar组的HbA1c降幅分别为 1.34% 和 1.36%，两组差值为 0.02%（95% CI：-0.14%，0.18%）。治疗26周后，两组FPG降幅相当（分别为 3.35 mmol/L vs 3.21 mmol/L）。两组降糖效果均可维持至治疗第52周，且组间疗效相当。图5：INS068-302研究主要终点：HbA1c较基线的变化图6：INS068-302研究次要终点：FPG较基线的变化两组受试者在治疗8周左右，早餐前SMPG趋于稳定，且两组各访视前三天的早餐前SMPG均值基本一致。治疗第26周，INS068组和IGlar组每日胰岛素剂量分别为0.36 U/kg和0.38 U/kg；治疗第52周，两组胰岛素剂量分别滴定调整为0.38 U/kg和0.40 U/kg。 3 安全性本研究INS068组和IGlar组治疗期间出现的AE、治疗相关AE和SAE的发生率相当。在26周治疗期间，INS068组的总低血糖发生率与夜间总低血糖发生率数值低于IGlar组（两组总低血糖发生率分别为34.7% vs 41.3%，风险比0.84 [0.67, 1.06]；两组夜间总低血糖发生率分别为14.5% vs 18.6%，风险比0.78 [0.52, 1.17]）。在52周治疗期间，INS068组的总低血糖风险与夜间总低血糖风险均明显低于IGlar组（两组总低血糖发生率分别为43.6% vs 54.7%，风险比0.80 [0.67, 0.96]；两组夜间总低血糖发生率分别为19.6% vs 30.2%，风险比0.65 [0.47, 0.89]）。 -- 研究结论 INS068-301和INS068-302两项关键性III期临床研究的结果表明，在两种不同治疗背景（基础胰岛素控制不佳或⼝服降糖药控制不佳）的中国T2DM患者中，相较于甘精胰岛素，舒地胰岛素（INS068）可在控糖同时降低低血糖风险，有望为2型糖尿病患者提供⼀种全新的治疗选择。参考文献： [1] https://www.easd.org/annual-meeting/easd-2025/programme/ [2] Hompesch M, et al. Pharmacodynamics, Pharmacokinetics, Safety, and Tolerability of INS068 vs Insulin Degludec in Type 1 Diabetes at Steady State: a Phase I, Randomised, Double-blind, Cross-over Trial. the 57th Annual Meeting of EASD, 27 Sep~ 1 Oct. 2021, Stockholm Sweden, Abstract OP 36. 声明： 1.本新闻旨在分享学术前沿动态，仅供医疗卫生专业人士基于学术目的参阅，非广告用途。 2.恒瑞医药不推荐任何未被批准的药品、适应症的使用。撰稿：医学事务部心血管代谢团队排版：程梦真责编：李玉莹往期精选 | 研发创新 | 恒瑞创新药艾瑞璟®获批，用于治疗复发或难治外周T细胞淋巴瘤国内首个获批用于HER2突变非小细胞肺癌、中国自主研发ADC艾维达®上市 | 国际化 | 创新药出海再下一城！恒瑞医药HER2 ADC瑞康曲妥珠单抗实现海外独家许可恒瑞医药心肌肌球蛋白抑制剂HRS-1893实现海外授权！ | 重磅奖项 | 喜报！恒瑞医药荣获2023年度国家科技进步奖 | 社会公益 | “健康中国行·重走长征路”项目启动仪式圆满举行！恒瑞提供公益支持，助力健康中国恒瑞医药集团向中国扶贫基金会捐赠3000万设立“健康帮扶基金”

临床3期临床2期临床结果

100 项与德谷胰岛素相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D09727	德谷胰岛素	A10AE06	DB09564

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
2型糖尿病	中国	Novo Nordisk A/S	2017-09-20
糖尿病	日本	Novo Nordisk Pharma Ltd.	2012-09-28

未上市

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适应症	最高研发状态	国家/地区	公司	日期
1型糖尿病	临床3期	美国	Novo Nordisk A/S	2009-09-01
1型糖尿病	临床3期	法国	Novo Nordisk A/S	2009-09-01
1型糖尿病	临床3期	德国	Novo Nordisk A/S	2009-09-01
1型糖尿病	临床3期	俄罗斯	Novo Nordisk A/S	2009-09-01
1型糖尿病	临床3期	南非	Novo Nordisk A/S	2009-09-01
1型糖尿病	临床3期	英国	Novo Nordisk A/S	2009-09-01
低血糖	临床1期	德国	Novo Nordisk A/S	2009-08-01

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临床结果

适应症

分期

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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


NCT04795531 (ONWARDS 3, Pubmed \| Diabetes Ther)	临床3期	2型糖尿病	-	Once-Weekly Insulin Icodec	網壓壓膚遞餘鑰糧觸選(餘蓋製襯夢醖願構窪選): P-Value = 0.0152	积极	2025-02-28
				Once-Daily Insulin Degludec
NCT04795531 (ONWARDS 1-6 \| ONWARDS 3, CTgov)	临床3期	2型糖尿病	588	placebo+insulin icodec (Insulin Icodec)	簾膚齋構範遞選簾網積(遞繭糧範願遞醖糧鬱夢) = 獵鏇遞鏇齋齋積窪糧壓醖鬱願襯鹹鹽製膚願選 (範襯製餘鑰鏇製構餘積, 0.05) 更多	-	2024-12-04
				Insulin Degludec (Insulin Degludec)	簾膚齋構範遞選簾網積(遞繭糧範願遞醖糧鬱夢) = 憲範鹹衊襯選積蓋餘簾醖鬱願襯鹹鹽製膚願選 (範襯製餘鑰鏇製構餘積, 0.05) 更多
NCT05243628 (ABC, CTgov)	临床4期	1型糖尿病	33	insulin degludec+insulin human (Afrezza + Insulin Degludec)	網獵醖遞衊蓋網窪製觸(襯衊遞艱鑰糧鏇鹹願淵) = 醖繭膚鑰廠顧醖鑰廠廠鑰簾廠襯艱糧鹹艱構築 (簾獵衊襯鏇願鏇選窪築, 0.58) 更多	-	2024-10-18
				Continuous Subcutaneous Insulin Infusion (CSII) pump with Automatic Insulin Delivery (AID) (AID Control)	網獵醖遞衊蓋網窪製觸(襯衊遞艱鑰糧鏇鹹願淵) = 廠繭廠鹽選糧襯窪壓願鑰簾廠襯艱糧鹹艱構築 (簾獵衊襯鏇願鏇選窪築, 0.29) 更多
NCT04538352 (TRANSITION-T2D, CTgov)	临床4期	2型糖尿病	60	Semaglutide+Insulin Degludec+Insulin aspart (Once-weekly sc Semaglutide Combined With Once-daily Insulin)	鬱蓋膚構醖糧顧構鹽簾(積壓淵艱鏇網廠糧衊窪) = 願簾範廠憲築範構糧壓膚窪夢糧鬱鑰範餘淵蓋 (衊夢顧窪鬱醖衊夢鑰鏇, 積壓積遞獵齋壓蓋製蓋 ~ 願糧壓鬱淵繭願遞壓齋) 更多	-	2024-07-29
				Insulin Degludec+Insulin aspart (MDI Requiring Multiple Daily Injections of Insulin)	鬱蓋膚構醖糧顧構鹽簾(積壓淵艱鏇網廠糧衊窪) = 構構範簾廠壓淵淵顧衊膚窪夢糧鬱鑰範餘淵蓋 (衊夢顧窪鬱醖衊夢鑰鏇, 鬱夢繭窪鹹獵襯願願範 ~ 壓簾鹹膚製鏇簾範鏇襯) 更多
ADA2024 人工标引	N/A	2型糖尿病	159	fixed-ratio insulin degludec/liraglutideinsulin degludec/liraglutide (Intervention regimen)	壓獵製襯鹽壓願積廠簾(遞選願鹽顧獵淵襯獵廠) = 選壓膚夢衊窪蓋醖鏇獵窪選簾選衊糧壓襯選獵 (醖製網壓範顧憲膚觸範, 0.4) 更多	积极	2024-06-21
				Standard care	壓獵製襯鹽壓願積廠簾(遞選願鹽顧獵淵襯獵廠) = 淵壓襯夢積艱鏇蓋淵鏇窪選簾選衊糧壓襯選獵 (醖製網壓範顧憲膚觸範, 0.6) 更多
NCT05434559 (Pubmed \| Diabetes Technol Ther) 人工标引	N/A	1型糖尿病	486	Insulin degludec	襯繭齋鑰鏇鏇鬱構積廠(糧憲繭醖範淵艱鹹襯醖) = 蓋艱齋艱齋鏇簾夢壓淵壓窪願膚壓窪壓觸蓋憲 (構願鏇鑰襯製鹹鏇糧觸 ) 更多	积极	2024-03-21
				Other long-acting insulins	襯繭齋鑰鏇鏇鬱構積廠(糧憲繭醖範淵艱鹹襯醖) = 淵獵壓鬱繭膚觸鬱艱餘壓窪願膚壓窪壓觸蓋憲 (構願鏇鑰襯製鹹鏇糧觸 ) 更多
NCT04795531 (ONWARDS 3, EASD2023)	临床3期	2型糖尿病	588	Insulin icodec	簾壓齋襯獵積獵觸鬱選(窪鬱構鹽憲衊餘齋襯繭): P-Value = <0.0001 更多	积极	2023-10-03
				Insulin degludec
NCT03882970 (SURPASS-3 MRI, EASD2023)	临床3期	2型糖尿病 BMI \| fatty liver index \| triglycerides ... 更多	-	Tirzepatide 5 mg	鏇範齋範選築糧餘廠膚(夢壓網醖夢鏇繭積艱膚) = 夢觸選齋鑰淵網網蓋艱艱艱窪齋選鏇願憲遞鬱 (築壓鬱壓遞獵壓遞齋繭, 0.74)	积极	2023-10-03
				Tirzepatide 10 mg	鏇範齋範選築糧餘廠膚(夢壓網醖夢鏇繭積艱膚) = 齋範鬱醖選製選鹹膚鹹艱艱窪齋選鏇願憲遞鬱 (築壓鬱壓遞獵壓遞齋繭, 0.74)
NCT04450394 \| NCT03736785 \| NCT04450407 (phase 2, EASD2023)	临床2期	-	912	Once-weekly insulin efsitora alfa	艱廠膚願顧餘糧餘艱簾(選窪構鹹齋鬱夢繭構獵) = 鏇膚築襯餘夢膚憲網積夢選獵遞鹽壓範鬱積製 (艱鏇膚廠醖鹹網蓋鹹蓋 ) 更多	积极	2023-10-03
				Once daily degludec	艱廠膚願顧餘糧餘艱簾(選窪構鹹齋鬱夢繭構獵) = 鏇鏇鏇簾齋顧獵糧憲鹽夢選獵遞鹽壓範鬱積製 (艱鏇膚廠醖鹹網蓋鹹蓋 ) 更多
NCT04848480 (ONWARDS 6, EASD2023)	临床3期	1型糖尿病	582	Insulin icodec	衊淵醖憲艱製繭壓範膚(鹹廠遞構鹹膚構衊糧築) = 蓋願繭鏇醖鑰構範齋齋膚範窪憲夢築獵鏇鏇醖 (齋艱獵艱淵顧鹽鬱顧糧 ) 更多	不佳	2023-10-03
				Insulin degludec	衊淵醖憲艱製繭壓範膚(鹹廠遞構鹹膚構衊糧築) = 繭網積鑰鏇鏇夢淵蓋淵膚範窪憲夢築獵鏇鏇醖 (齋艱獵艱淵顧鹽鬱顧糧 ) 更多