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更新于：2026-10-09

Metformin

二甲双胍

更新于：2026-10-09

概要

基本信息

药物类型

小分子化药

别名

HENFORMIN F.C.、ANJ 900、ANJ-900

+ [3]

靶点

GPD1 x PRKAB1

作用方式

调节剂、激活剂

作用机制

GPD1调节剂(glycerol-3-phosphate dehydrogenase 1 modulators)、PRKAB1激活剂(腺苷酸活化蛋白激酶亚基β1激活剂)

治疗领域

肿瘤内分泌与代谢疾病其他疾病+ [10]

在研适应症

黏液瘤腹膜假性粘液瘤室管膜瘤+ [18]

非在研适应症

抑郁症2型糖尿病分化型甲状腺癌+ [2]

原研机构

Elcelyx Therapeutics, Inc.

在研机构

北京协和医院

University of Minnesota Medical School

四川大学

+ [10]

非在研机构

National Institute on Drug Abuse

Anji Pharmaceuticals, Inc.

The Medical University of South Carolina

+ [3]

权益机构

安济药业（上海）有限公司

Emory University

Elcelyx Therapeutics, Inc.

+ [3]

最高研发阶段临床2期

首次获批日期-

最高研发阶段(中国)临床前

特殊审评-

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结构/序列

分子式C4H11N5

InChIKeyXZWYZXLIPXDOLR-UHFFFAOYSA-N

CAS号657-24-9

关联

346

项与二甲双胍相关的临床试验

NCT07864649

/ Not yet recruitingN/A

ERSIAS IIb. EDAS Revascularization for Symptomatic Intracranial Atherosclerotic Steno-Occlusive Disease. Phase IIb Clinical Trial

ERSIAS IIb is a multicenter randomized controlled trial, with a Phase IIb design, to find out whether encephaloduroarteriosynangiosis (EDAS), a type of indirect surgical revascularization of the brain, added to intensive medical management, lowers the rate of recurrent stroke and death compared with intensive medical management alone. The trial enrolls 170 adults who have had a recent ischemic stroke or transient ischemic attack caused by intracranial atherosclerotic disease, with a narrowing or blockage of at least 70% of the intracranial internal carotid artery or the middle cerebral artery and reduced blood flow in the territory of that artery. Participants are assigned at random, in equal numbers, to EDAS plus intensive medical management or to intensive medical management alone, and are followed for 18 to 54 months.

开始日期2027-05-01

申办/合作机构

Cedars-Sinai Medical Center

[+1]

NCT07007221

/ Withdrawn临床2期IIT

Clinical Trials to Evaluate Metformin to Treat Depression in People Living With HIV

Depression in HIV occurs commonly and causes poor HIV outcomes with public health implications.
Depression prevalence in HIV-infected persons is estimated at 26% compared to 5% in the general population. Adherence to antiretroviral medication is a life-saving treatment in HIV, but depression can reduce engagement in care and adherence to medication. Depression is also associated with poorer levels of viral suppression and even mortality. Overall, those with depression and HIV are less likely to return to health and remain more likely to transmit the virus. therefore, treatment of HIV is essential to prevention; lower engagement in and adherence to HIV treatment due to depression puts others at risk. This is a 3 part trial, an initial pilot, a placebo controlled pilot, and a full trial.
Part 1. Dose response, Tolerability/Acceptability of Metformin for Depression in people with HIV: To do Initial assessment of metformin for depression in people with HIV we will perform a randomized, double blind, 2-arm, 12 week randomized controlled trial to assess feasibility and acceptability of metformin for depression. We will test two doses of metformin 1000 mg daily versus 1500 mg daily.
Part 2. Preliminary Efficacy Trial of Metformin for Depression in People with HIV: This will be a two-arm, double-blind trial of metformin versus placebo in people with HIV and depression. We will randomize individuals 1:1 to metformin or placebo. Will then collect blood and rectal swabs for preliminary assessments of the mechanism of action for metformin in people with HIV and depression.
Part 3. Full efficacy factorial trial of metformin for depression and comparison/interaction with fluoxetine in people living with HIV: To assess metformin and fluoxetine as efficacious treatments for depression in people with HIV, we will conduct a 4-arm, 12-week, mechanistic, double-blinded, randomized controlled treatment trial (RCT) with an assessment of inflammation and the gut microbiome. Participants (n=400) will be HIV- positive patients on ART with comorbid depression receiving care at one of two Ugandan clinics. In addition, we will use the NIMH Research Domain Criteria (RDoC) of Acute Threat and loss under Negative Valence using biomarkers and self-reported tools.

开始日期2026-07-01

申办/合作机构

University of Minnesota

NCT07693452

/ Recruiting临床2期IIT

Use of Metformin in Patients With Pseudomyxoma Peritonei Secondary to Appendiceal Mucinous Neoplasms

This is a pilot, open-label clinical trial determining the feasibility of metformin therapy in subjects with pseudomyxoma peritonei (PMP) secondary to appendiceal mucinous neoplasms (AMNs).

开始日期2026-06-18

申办/合作机构

University of California, Irvine

100 项与二甲双胍相关的临床结果

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100 项与二甲双胍相关的转化医学

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100 项与二甲双胍相关的专利（医药）

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32,566

项与二甲双胍相关的文献（医药）

2027-02-01·TISSUE & CELL

Mechanism of Gegen Qinlian Decoction in the treatment of diabetic cataract based on network pharmacology and experimental validation

Article

作者: Peng, Shuhong ; Zhu, Weifeng ; Gui, Ting ; Wang, Xin ; Fu, Xiaomei ; Tang, Jing ; Xu, Ruixiang ; Yu, Liping ; Xia, Juanjuan ; Liu, Jing ; Zhong, Weihong ; Wu, Wenting

Diabetic cataract (DC) is one of the most common complications of diabetes mellitus, currently lacks effective treatments. Gegen Qinlian Decoction (GQD) is effective against diabetes and its complications, but its efficacy and mechanism against diabetic cataracts remain unclear. In this study, the effects and mechanisms of GQD in treating diabetic cataracts were evaluated in Zucker diabetic fatty (ZDF) rats. All rats were randomly divided into control, model, low/high-dose GQD and metformin groups. Each group was administered the drug or an equal volume of distilled water for 12 weeks. Fasting blood glucose and body weight were measured every two weeks. At the end of the experiment, the degree of lens opacity was examined. Pathological changes in the lenses were observed by hematoxylin-eosin staining. The contents of soluble proteins, malondialdehyde (MDA), superoxide dismutase (SOD) and sorbitol were measured in the lenses. Network pharmacology was employed to predict the signaling pathways of GQD in treating DC. Additionally, the protein expressions of p38, JNK and their phosphorylation levels were evaluated by Western blot. The results showed that GQD significantly alleviated lens opacity, reduced sorbitol accumulation and ameliorated oxidative stress in rats with DC. Network pharmacology revealed that the MAPK signaling pathway is a key regulatory pathway of GQD against DC. Western blot results further confirmed that GQD significantly downregulated the phosphorylation levels of p38 and JNK in the lenses of rats with DC.This study implicates GQD as a potential therapeutic candidate for DC.

2027-02-01·TALANTA

Metformin-integrated luminescent hydrogen-bonded organic framework for rapid and selective fluorescent detection of hypochlorite

Article

作者: Xie, Haijiao ; Liu, Honglin ; Chen, Leyi ; Liu, Jiale ; Chen, Jinai ; Wang, Hongyan ; Li, Ning

Hypochlorite (ClO^-), a widely used oxidant in disinfection and bleaching processes, requires rapid and reliable analytical detection because of its strong reactivity and widespread use. Herein, a metformin-integrated terbium-doped hydrogen-bonded organic framework (Tb@PMA-MET) was developed as a luminescent sensing platform that integrates molecular recognition with lanthanide luminescent transduction. The integrated metformin units provide electron-rich guanidine sites for selective hypochlorite recognition, while Tb³⁺ serves as the emissive center through the antenna effect. The sensor exhibited a rapid response within 10.3 s, high sensitivity with a detection limit of 104 ng mL^-1, and a broad linear range of 0.1-100 μg mL^-1. In addition, enhanced Stern-Volmer quenching behavior was observed for Tb@PMA-MET compared with the Tb@PMA reference material. Fluorescence lifetime measurements, PXRD, FT-IR, XPS, and density functional theory calculations collectively suggested that hypochlorite preferentially interacts with metformin units, accompanied by chemical transformation and excited-state deactivation. The sensing platform was further validated by spike-and-recovery analysis in diluted bleach and tap water matrices. This work demonstrates the potential of metformin-integrated luminescent HOFs as fluorescent sensing platforms for rapid hypochlorite analysis in representative aqueous matrices.

2027-01-01·JOURNAL OF ETHNOPHARMACOLOGY

Mulberry leaf flavonoids alleviate type 2 diabetes by remodeling the gut microbiota-bile acid axis and activating FXR signaling

Article

作者: Dong, Yuekun ; Zhao, Baosheng ; Liu, Gaiting ; Xie, Jiamei ; Zhao, Yige ; Yang, Yang ; Liu, Shuchang ; He, Changhao ; An, Yongcheng ; Zhang, Huilin ; Shi, Lu ; Wang, Guohua ; Huang, Yan ; Du, Yuhang ; Fu, Wanxin ; Bu, Sitong

ETHNOPHARMACOLOGICAL RELEVANCE:

Mulberry leaf (Morus alba L.) has long been used in traditional Chinese medicine for treating "Xiaoke" (diabetes), as documented in "Compendium of Materia Medica" compiled by Li Shi-Zhen of the Ming Dynasty. Mulberry leaf flavonoids (MLF) are the major active components and have demonstrated anti-diabetic effects in modern studies. However, whether MLF alleviates type 2 diabetes mellitus (T2DM) by modulating the gut microbiota-bile acid axis and directly activating key metabolic receptors such as FXR remains unclear.

AIM OF THE STUDY:

This study aimed to investigate whether MLF ameliorates T2DM through remodeling the gut microbiota-bile acid axis and activating FXR signaling, and to identify potential flavonoid constituents within MLF that directly interact with FXR.

MATERIALS AND METHODS:

db/db mice were treated with low- or high-dose MLF (300 or 600 mg/kg/day) or metformin for 10 weeks. Blood glucose, insulin sensitivity, lipid profiles, and hepatic pathology were assessed. Gut microbiota composition was analyzed by 16S rRNA sequencing, and bile acid profiles in serum, liver, ileum, and feces were quantified by targeted metabolomics. The expression of FXR/TGR5 signaling pathway components was determined by qRT-PCR and Western blot. Molecular docking was performed to screen for potential FXR modulator among MLF constituents, followed by in vitro validation using HepG2 and Caco-2 cells.

RESULTS:

MLF treatment significantly reduced fasting blood glucose, improved glucose tolerance and insulin resistance, lowered serum and hepatic lipid levels, and alleviated hepatic steatosis in db/db mice. MLF reshaped the gut microbiota by increasing beneficial genera (e.g., Alloprevotella, Roseburia) and decreasing the Firmicutes/Bacteroidetes ratio. Concurrently, MLF reprogrammed bile acid profiles across multiple organs, elevating non-12-OH bile acids (e.g., CDCA) and reducing the FXR antagonist Tβ-MCA, thereby activating intestinal and hepatic FXR/TGR5 signaling, upregulating FGF15 and SHP, and increasing serum GLP-1. Molecular docking identified Morusin as a candidate FXR ligand, and in vitro assays confirmed that both MLF and Morusin activated FXR and modulated downstream targets (BSEP, NTCP, ASBT, CYP7A1) in hepatocytes and intestinal cells.

CONCLUSION:

MLF alleviates T2DM by remodeling the gut microbiota-bile acid axis and activating FXR/TGR5 signaling. Morusin, a flavonoid constituent of MLF, is a potential FXR-modulating compound. These findings provide a modern mechanistic rationale for the traditional use of mulberry leaf in treating diabetes and support the development of MLF as a gut-targeted therapeutic strategy for T2DM.

5,063

项与二甲双胍相关的新闻（医药）

2026-10-09

·生物世界

连发两篇Nature Medicine：恒瑞医药口服小分子GLP-1受体激动剂，为2型糖尿病带来治疗新选择

撰文丨王聪编辑丨王多鱼排版丨水成文全球约有 5.89 亿成年人患有糖尿病，其中超过 90% 为 2 型糖尿病。Safiglipron（HRS-7535）是由恒瑞医药研发的口服小分子 GLP-1 受体激动剂，无需注射、每日服用一次，且无需空腹或饮食限制即可服用。 2026 年 9 月 29 日，北京协和医院肖新华、恒瑞医药叶子等在国际顶尖学术期刊 Nature Medicine 上发表了题为：Oral small-molecule GLP-1 receptor agonist safiglipron in early type 2 diabetes: a randomized, double-blind, placebo-controlled trial 的研究论文。该论文报告了 OUTSTAND-1 临床 3 期试验结果，结果显示，Safiglipron 单药治疗可显著改善早期 2 型糖尿病患者的血糖控制，较高剂量同时带来体重获益，且观察到胰岛功能及多项心肾代谢相关指标的改善。研究团队在一项在中国 46 个医学中心开展的 3 期、多中心、随机、双盲、安慰剂对照试验 OUTSTAND-1 中评估了 Safiglipron 的有效性和安全性。研究团队将 284 名仅通过饮食和运动控制的 2 型糖尿病成人患者（基线平均 HbA1c 为 7.95%，中位糖尿病病程为 1.6 年，女性占比 33.1%）随机分配至每日一次口服 Safiglipron 30 mg（n=70）、60 mg（n=70）、90 mg（n=72）或安慰剂（n=72），持续 32 周，随后进入为期 20 周的开放标签延长期治疗。主要终点显示，与安慰剂相比，各剂量组在第 32 周时 HbA1c 较基线的变化差异分别为：30 mg 组为 -1.22%，60 mg组为 -1.20%、90 mg 组为 -1.45%。次要终点显示，HbA1c < 7.0% 的比例分别为 71.4%-77.8% vs 25.0%，HbA1c ≤ 6.5% 的比例分别为 58.6%–68.1% vs 16.7%，以及空腹血浆葡萄糖的安慰剂校正差异分别为 -1.58、-1.68 和 -2.08 mmol/L。与安慰剂相比，各剂量组的体重差异较小（分别为 -0.65%、-2.23% 和 -3.56%）。其他次要终点总体上更有利于 Safiglipron，包括实现 HbA1c < 5.7% 的比例、餐后血糖、胰岛 β 细胞功能稳态模型评估（HOMA-β）、胰岛素抵抗稳态模型评估（HOMA-IR）、处置指数以及腰围，并且补救治疗的使用较少。胰岛素和 C 肽反应因剂量而异，治疗满意度的变化有限。胃肠道不良事件最为常见，且多为轻度或中度。不良事件导致接受 Safiglipron 30 mg、60 mg、90 mg 和安慰剂的受试者分别有 1.4%、2.9%、6.9% 和 0% 中断治疗。总的来说，这些结果支持每日一次口服 Safiglipron 作为 2 型糖尿病的有效治疗选择。 2026 年 10 月 5 日，恒瑞医药叶子、中国医学科学院老年医学研究院/北京医院·国家老年医学中心郭立新教授等，在国际顶尖医学期刊 Nature Medicine 上发表了题为：Oral small-molecule GLP-1RA safiglipron versus dapagliflozin in type 2 diabetes: a randomized, double-blind, active-comparator-controlled phase 3 trial 的研究论文。该论文报告了 OUTSTAND-2 临床 3 期试验结果，这项口服小分子 GLP-1 受体激动剂领域首个与 SGLT2 抑制剂进行头对头比较的 3 期临床研究表明，对于二甲双胍控制不佳的 2 型糖尿病患者，Safiglipron 不劣于 SGLT2 抑制剂达格列净，从而为 2 型糖尿病患者提供了除注射类 GLP-1 受体激动剂和 SGLT2 抑制剂之外的新选择。该研究在 OUTSTAND-2 研究中评估了 Safiglipron 的疗效和安全性，该研究是一项在中国 98 个医学中心开展的 3 期、多中心、随机、双盲、双模拟、活性对照试验。研究团队我们将 810 名成人（平均糖化血红蛋白 HbA1c 为 8.60%，中位糖尿病病程 5.0年，女性占比 35.7%）随机分配至 Safiglipron30 mg 组（n=202）、Safiglipron 60 mg 组（n=203）、Safiglipron 90 mg 组（n=203）或达格列净 10 mg 组（n=202），治疗 32 周，随后进入为期 20 周的开放标签延长期。在主要终点指标上，根据主要非劣效性估计量，在第 32 周时与达格列净相比，Safiglipron 30 mg、60 mg和90 mg组在HbA1c基线变化上的治疗差异分别为 -0.30%、-0.22% 和 -0.40%，三组均达到非劣效性标准（所有 P 值<0.0001；非劣效性界值为 0.4%）。在治疗策略的评估指标下，90 mg 剂量达到了预设的优效性统计标准（差异为 -0.25%），而 60 mg 剂量未达到（P = 0.0789），随后固定顺序检验终止。与达格列净相比，Safiglipron 实现 HbA1c 目标的达标率分别为：HbA1c <7.0% 时为 54.9%–63.5% vs 36.5%，HbA1c ≤6.5% 时为 38.9%–48.6% vs 16.1%。平均体重变化分别为：Safiglipron 30 mg、60 mg、90 mg 和达格列净组为 -2.35%、-3.55%、-4.17% 和 -3.60%。空腹血浆葡萄糖、七点自我监测血糖谱、腰围、HOMA-β、HOMA-IR 以及治疗满意度的变化在 Safiglipron 和达格列净治疗下均表现出不同程度的基线改善，分别有 0.5%–1.5% 和 0% 的受试者使用了补救治疗。胃肠道不良事件在 Safiglipron 组中更常见，但多为轻度或中度；因不良事件导致治疗中断的比例分别为 4.0%、4.0%、3.9% 和 1.5%。总的来说，这些结果表明，Safiglipron 为使用二甲双胍控制不佳的 2 型糖尿病成人患者提供了一种有效的口服治疗选择。论文链接： https://www.nature.com/articles/s41591-026-04651-9 https://www.nature.com/articles/s41591-026-04713-y 设置星标，不错过精彩推文开放转载欢迎转发到朋友圈和微信群微信加群为促进前沿研究的传播和交流，我们组建了多个专业交流群，长按下方二维码，即可添加小编微信进群，由于申请人数较多，添加微信时请备注：学校/专业/姓名，如果是PI/教授，还请注明。点在看，传递你的品味

2026-10-09

·恒瑞医药

2026 EASD口头报告︱恒瑞医药基础胰岛素周制剂SHR-3167两项2型糖尿病Ⅱ期研究成果亮相

全球糖尿病领域规模最大的学术会议之一——第62届欧洲糖尿病研究协会（EASD）年会于9月28日至10月2日在意大利米兰举行。期间，恒瑞医药自主研发的基础胰岛素周制剂SHR-3167携两项最新研究成果亮相最新突破摘要（Late-Breaking Abstract，LBA）环节[1][2]。 SHR-3167作为一款新型胰岛素周制剂，其半衰期为10.4-11.9天，已在Ⅰ期临床研究2 型糖尿病（T2DM）患者中展现出良好的获益和耐受性[3]，其设计理念旨在通过延长作用时间、减少血糖波动，为糖尿病患者提供更便捷的治疗选择。 SHR-3167-201研究由上海市第六人民医院贾伟平教授和江苏省人民医院刘云教授作为主要研究者。SHR-3167-202研究由复旦大学附属中山医院李小英教授和重庆医科大学附属第一医院李启富教授作为主要研究者。两项研究结果表明[1][2]，在口服降糖药治疗血糖控制不佳或既往接受基础胰岛素的2型糖尿病患者中，每周一次SHR-3167降低糖化血红蛋白（HbA1c）的效果与每日一次甘精或德谷胰岛素相当，且葡萄糖目标范围内时间（TIR）百分比改善程度在数值上更高，整体安全性及低血糖发生情况相似。 2026 EASD现场图：恒瑞医药曾梅芳博士就SHR-3167-201研究进行口头报告 2026 EASD现场图：复旦大学附属中山医院赵琳博士就SHR-3167-202研究进行口头报告摘要编号：LBA-97 SHR-3167-201研究：评估每周一次SHR-3167与每日一次甘精胰岛素U100在口服降糖药治疗血糖控制不佳的T2DM患者中的有效性和安全性[1] 01 研究设计这项多中心、随机、开放标签、达标治疗的Ⅱ期临床研究（试验编号：NCT06688123）旨在评估SHR-3167对比甘精胰岛素U100在口服降糖药治疗血糖控制不佳的T2DM患者中的有效性和安全性。研究主要纳入年龄18-65岁、BMI 18.5-35.0 kg/m²、确诊T2DM≥6个月（HbA1c 7.5%-10.0%）、未使用过胰岛素（背景治疗为二甲双胍单药或联合SGLT2抑制剂）的T2DM患者。参与者以1:1:1的比例随机分配至SHR-3167 A组（起始剂量7mg，滴定幅度±2mg，每周一次）、SHR-3167 B组（起始剂量7mg，滴定幅度±1.5mg，每周一次）、甘精胰岛素U100组（起始剂量10U，滴定幅度±3U，每日一次）。主要研究终点为治疗20周后HbA1c相对基线的变化，次要研究终点为治疗最后4周期间的TIR和治疗20周后早餐前自我血糖监测（SMBG）、体重等较基线的变化，同时评估安全性终点。 02 研究结果 1 基线特征研究共计纳入275名参与者，264名完成全程治疗。各组参与者基线人口学特征以及疾病特征总体分布均衡，具有良好的组间可比性。基线人口统计学特征和临床特征 2 主要研究终点在第20周时，SHR-3167 A组、SHR-3167 B组和甘精胰岛素U100组HbA1c较基线变化的最小二乘均值分别为 -1.37%、 -1.49%和 -1.35%；与甘精胰岛素U100组相比，组间差异分别为-0.02% (95% CI： -0.20，0.16)和-0.14% (95% CI ：-0.32，0.05)。以上结果表明，治疗20周后，SHR-3167 A组和B组HbA1c相对基线的降低幅度与甘精胰岛素组总体相近。 HbA1c较基线变化的最小二乘均值趋势 3 次要研究终点治疗最后4周期间，各组TIR分别为：SHR-3167 A组 70.28%，SHR-3167 B组 75.15%，甘精胰岛素U100组 69.86%。与甘精胰岛素U100组相比，组间差异分别为： 0.42% (95% CI：-3.82，4.66)和5.29% (95% CI：0.97，9.61)。各组全天TIR相对基线的相应改善情况分别为：SHR-3167 A组23.55%（≈5小时39分钟/天），SHR-3167 B组28.42%（≈6小时49分钟/天），甘精胰岛素U100组23.13%（≈5小时33分钟/天）。基线及治疗最后4周期间各组全天TAR（葡萄糖高于目标范围时间）、 TIR、TBR（葡萄糖低于目标范围时间）时间占比ⁱ 第20周时，与基线相比，各组的早餐前SMBG变化、体重变化均相似。 4 安全性各组整体安全性发生情况相似，大多数为轻至中度。未发生3级低血糖事件。低血糖事件率 03 研究结论在口服降糖药治疗血糖控制不佳的2型糖尿病患者中，与每日一次甘精胰岛素U100相比，每周一次SHR-3167在降低HbA1c的效果相当，TIR改善程度（SHR-3167 B组）在数值上更高，整体安全性及低血糖发生情况相似。支持进一步开发SHR-3167作为一种便捷的每周一次基础胰岛素治疗方案。摘要编号：LBA-96 SHR-3167-202研究：评估每周一次SHR-3167与每日一次德谷胰岛素在既往接受基础胰岛素的T2DM患者中的有效性和安全性[2] 01 研究设计这项多中心、随机、开放标签、达标治疗的Ⅱ期临床研究（试验编号：NCT07018453）旨在评估SHR-3167对比德谷胰岛素在既往接受基础胰岛素的T2DM患者中的有效性和安全性。研究主要纳入年龄18-65岁、BMI 18.5-35.0 kg/m²、确诊T2DM≥6个月（HbA1c 6.5%-10.0%）的T2DM患者，其中基础胰岛素治疗持续≥90天（合并或不合并二甲双胍、SGLT2抑制剂或两者联合使用）。参与者以1:1:1的比例随机分配至SHR-3167 负荷剂量组（LD）（首次给予3倍负荷剂量，滴定幅度±1.5mg，每周一次）、SHR-3167 非负荷剂量组（NLD）（滴定幅度±1.5mg，每周一次）、德谷胰岛素U100（滴定幅度±3U，每日一次）。主要研究终点为治疗16周后，HbA1c相对基线的变化，次要研究终点为治疗最后2周期间的TIR和治疗16周后早餐前SMBG等较基线的变化。 02 研究结果 1 基线特征研究共计纳入173名参与者，166名（96.0%）参与者完成全程治疗。各组参与者基线人口学特征以及疾病特征总体分布均衡，具有良好的组间可比性。基线人口统计学特征和临床特征 2 主要研究终点治疗16周后，SHR-3167 LD组、NLD组和德谷胰岛素组HbA1c较基线变化的最小二乘均值分别为-0.57%、-0.61%和-0.33%；与德谷胰岛素组相比，组间差异分别为-0.24%（95% CI：-0.55%，0.07%）和-0.27%（95% CI：-0.58%，0.03%）。以上结果表明，治疗16周后，SHR-3167两组HbA1c相对基线的降低幅度与德谷胰岛素组总体相近，且数值上更高。 HbA1c较基线变化的最小二乘均值趋势 3 次要研究终点治疗最后2周期间，各组TIR分别为：SHR-3167 LD组 59.9%，SHR-3167 NLD组 59.2%，德谷胰岛素组51.8%。与德谷胰岛素组相比，组间差异分别为：8.09% (95% CI：1.31，14.88) 和 7.41% (95% CI：0.81，14.01)。各组TIR相对基线的相应改善情况为ⁱⁱ：SHR-3167 LD组14.1% (≈3小时23分钟/天)，SHR-3167 NLD组13.4% (≈3小时13 分钟/天)，德谷胰岛素组6.0% (≈1小时26分钟/天)。治疗16周后，与基线相比，各组在早餐前SMBG变化均相似。 4 安全性各组整体安全性发生情况相似，大多数为轻至中度。低血糖事件主要为1级，未发生2级或3级低血糖。 03 研究结论在既往接受基础胰岛素的T2DM患者中，与每日一次德谷胰岛素相比，每周一次SHR-3167在降低HbA1c的效果相当，TIR改善程度在数值上更高，整体安全性及低血糖发生情况相当。支持进一步开发SHR-3167作为一种便捷的每周一次基础胰岛素治疗方案。 ⁱ基线为均值，第16-20周为最小二乘均值。 ⁱⁱ基线为均值，第15-16周为最小二乘均值。参考文献： 1. F. Gao, X. Zheng, C. Ying, et al. Once-weekly insulin SHR-3167 versus once-daily insulin glargine U100 in type 2 diabetes without previous insulin treatment. EASD 62nd Annual Meeting, Milan, 2026.2. L. Zhao, Q. Li, Y. Song, et al. Efficacy and safety of once-weekly insulin SHR-3167 vs daily insulin degludec in type 2 diabetes participants previously treated with basal insulin with or without oral antidiabetic drugs. EASD 62nd Annual Meeting, Milan, 2026. 3. C TANG, et al; Diabetes. 20 June 2025; 74 (Supplement_1): 811–P. 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：非肿瘤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 | 中国首个自主研发长效胰岛素类似物！恒瑞医药创新药瑞恒盈®获批上市 | 国际化 | 恒瑞医药与诺和就每周一次口服GLP-1/GIP双受体激动剂HRS-1596达成独家许可协议恒瑞医药与百时美施贵宝达成战略合作协议，携手推进肿瘤学、血液学及免疫学创新疗法 | 重磅奖项 | 再传捷报！恒瑞医药创新药氟唑帕利胶囊（艾瑞颐®）专利荣获中国专利金奖捷报！恒瑞医药创新药海曲泊帕乙醇胺片（恒曲®）专利荣获中国专利金奖 | 社会公益 | 恒瑞医药捐赠1000万港元，驰援香港大埔火灾救助 “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

临床2期临床结果

2026-10-08

·PRNewswire

Dipeptidyl Peptidase-4 (DPP-4) Inhibitors Market to Reach USD 15,527.66 Million by 2032 - Credence Research

LONDON, Oct. 8, 2026 /PRNewswire/ -- The "Dipeptidyl Peptidase-4 (DPP-4) Inhibitors Market – Growth, Share, Opportunities & Competitive Analysis, 2026–2032" report has been added to the Credence Research Inc. offering. The global Dipeptidyl Peptidase-4 (DPP-4) Inhibitors Market was valued at USD 11,280.60 million in 2025 and is projected to reach USD 15,527.66 million by 2032, registering a CAGR of 5.47%. Demand is supported by the persistent global burden of type 2 diabetes, continued use of oral glucose-lowering therapies and the expanding availability of generics and fixed-dose combinations. DPP-4 inhibitors remain relevant for selected patients who benefit from simple oral dosing, low hypoglycemia risk and weight-neutral treatment profiles, although newer incretin and cardiometabolic therapies are increasing competitive pressure. Key Takeaways The market is projected to rise from USD 11,280.60 million in 2025 to USD 15,527.66 million by 2032 at a CAGR of 5.47%. Sitagliptin led the drug type segment with a 36.9% share in 2025, supported by long-standing prescribing familiarity, broad availability and generic participation. Retail pharmacies accounted for 44.8% of 2025 revenue, reflecting repeat-refill behavior in chronic outpatient diabetes management. North America led with a 37.8% share in 2025, followed by Europe at 26.1% and Asia Pacific at 23.4%. Fixed-dose combinations with metformin remain strategically important because they can reduce pill burden and support stepwise treatment intensification. Validated core participants include Merck & Co., AstraZeneca, Boehringer Ingelheim, Takeda Pharmaceutical, Novartis, Eli Lilly, Lupin, Sun Pharmaceutical and Dr. Reddy's Laboratories. Scope & Segmentation – Dipeptidyl Peptidase-4 (DPP-4) Inhibitors Market The report provides a comprehensive analysis of the global DPP-4 Inhibitors Market through 2032, covering drug molecules, formulation formats, treatment sequencing, combination strategies, dispensing channels and patient groups. The study evaluates how generic entry, payer formularies, fixed-dose combinations and competition from GLP-1, dual incretin and SGLT2 therapies are reshaping commercial strategies. It also examines regional access, chronic refill infrastructure and molecule-level considerations that influence prescribing. The DPP-4 Inhibitors Market is segmented based on drug type, formulation, therapy line, combination type, distribution channel, patient type and geography. By Drug Type, the market includes Sitagliptin, Saxagliptin, Linagliptin, Alogliptin and Others. By Formulation, the market includes Oral Tablets, Fixed-dose Combinations and Others. By Therapy Line, the market includes First-line Therapy, Second-line Therapy, Add-on Therapy and Others. By Combination Type, the market includes Monotherapy, Combination with Metformin, Combination with SGLT2 and Others. By Distribution Channel, the market includes Hospital Pharmacies, Retail Pharmacies, Online Pharmacies and Others. By Patient Type, the market includes Type 2 Diabetes Adults, Elderly Patients, Renal-impaired Patients and Others. By Geography, the market is analyzed across North America, Europe, Asia Pacific, Latin America and Middle East & Africa. Access crucial information at unmatched prices! Request your sample report today and start making informed decisions powered by Credence Research Inc. Why This Report Matters The report provides a focused view of a mature but resilient oral diabetes drug class undergoing a transition from branded growth toward access-led generic volume. It helps decision-makers assess molecule-level demand, fixed-dose combination opportunities, distribution dynamics and evolving therapy-line positioning. The study highlights the commercial impact of newer diabetes classes that offer weight-loss or broader cardiometabolic benefits. For pharmaceutical manufacturers, generic drug companies, distributors and investors, the report provides actionable intelligence for portfolio, pricing and market-access decisions. Market Overview • Industry Landscape and Value Chain Assessment • Supply-Side Evaluation • Demand-Side Evaluation • Stakeholder Mapping • Porter's Five Forces Review • PESTLE Environment Assessment • Market Forecast and Future Direction • Short-Term Forecast, 0–2 Years • Mid-Term Forecast, 3–5 Years • Long-Term Forecast, 5–10 Years • Market Entry and Expansion Strategy Market Insights • Patient and Prescriber Analysis • Therapy Sequencing Assessment • Generic Entry and Substitution Review • Fixed-Dose Combination Opportunity Assessment • Distribution and Refill Channel Review • Pricing and Reimbursement Analysis • Competitive Class Substitution Assessment • Regional Access and Diagnosis Review • Lifecycle Management and Portfolio Strategy Key Attributes Segmentation By Drug Type • Sitagliptin • Saxagliptin • Linagliptin • Alogliptin • Others By Formulation • Oral Tablets • Fixed-dose Combinations • Others By Therapy Line • First-line Therapy • Second-line Therapy • Add-on Therapy • Others By Combination Type • Monotherapy • Combination with Metformin • Combination with SGLT2 • Others By Distribution Channel • Hospital Pharmacies • Retail Pharmacies • Online Pharmacies • Others By Patient Type • Type 2 Diabetes Adults • Elderly Patients • Renal-impaired Patients • Others By Geography • North America • Europe • Asia Pacific • Latin America • Middle East & Africa Market Growth Driven by Chronic Type 2 Diabetes Demand and Oral Therapy Preference The persistent global burden of type 2 diabetes supports recurring demand for oral glucose-lowering medicines. DPP-4 inhibitors retain a role in selected patients because they offer simple daily administration, a generally low risk of hypoglycemia and a weight-neutral profile. These characteristics can be valuable in older patients, people managing multiple medicines and treatment plans where tolerability is prioritized. Generic entry is changing the revenue mix. Loss of exclusivity has reduced branded pricing power in several markets, yet lower-cost sitagliptin and other molecules can expand access and preserve prescription volume. Wider retail pharmacy availability and e-pharmacy distribution also support continuity for chronic therapy users. Fixed-dose combinations remain an important lifecycle strategy. Pairing DPP-4 inhibitors with metformin or other oral agents can simplify regimens and support patients who require stepwise treatment intensification without moving immediately to injectable therapy. Competitive Pressure from Newer Diabetes Therapies Reshapes the Market DPP-4 inhibitors face stronger competition from GLP-1 receptor agonists, dual incretin therapies and SGLT2 inhibitors. These newer classes can offer weight reduction or broader cardiovascular and renal benefits in selected patient populations, which can influence guideline positioning and payer preference. This pressure makes affordability, tolerability, oral convenience and combination availability increasingly important sources of differentiation. Manufacturers must manage mature brands carefully while generic suppliers compete on price, supply reliability and pharmacy coverage. Regional Growth Reflects Reimbursement Depth and Expanding Access North America led the market with a 37.8% share in 2025, supported by established diagnosis pathways, structured reimbursement and a mature retail refill infrastructure. Europe accounted for 26.1%, where reference pricing and cost-containment policies accelerate generic uptake while preserving steady outpatient use. Asia Pacific represented 23.4% of the market and offers substantial volume potential due to large diabetes populations, improving diagnosis and expanding pharmacy access. Latin America and Middle East & Africa remain smaller in revenue terms, with growth dependent on affordability, distributor reach and reimbursement development. Future Outlook The DPP-4 inhibitor market is expected to expand steadily rather than rapidly through 2032. Growth will be supported by chronic disease prevalence, generic access and fixed-dose combinations, while class share will remain under pressure from newer therapies with stronger weight and cardiometabolic profiles. Companies with broad generic portfolios, strong local distribution and combination-product capabilities will be better positioned to defend volume. Market opportunities will increasingly center on affordability, emerging-market access and simplified regimens rather than premium pricing. Competitive Landscape Competition is shifting from brand exclusivity toward formulary placement, generic substitution, combination availability and supply reliability. Merck remains closely associated with sitagliptin, while AstraZeneca, Boehringer Ingelheim, Takeda and Novartis have established DPP-4 portfolios or legacy brands. Eli Lilly remains relevant through its long-standing collaboration with Boehringer Ingelheim around linagliptin. Generic manufacturers including Lupin, Sun Pharmaceutical and Dr. Reddy's Laboratories strengthen price competition and expand access in large emerging markets. The strongest commercial positions increasingly depend on distribution coverage, procurement competitiveness and the ability to sustain reliable supply after patent expiry. Key Player Analysis • Merck & Co. • AstraZeneca • Boehringer Ingelheim • Takeda Pharmaceutical • Novartis • Eli Lilly and Company • Lupin • Sun Pharmaceutical • Dr. Reddy's Laboratories Recent Industry Developments In June 2025, Abbott and MSD Pharmaceuticals announced a distribution agreement in India covering sitagliptin, sitagliptin/metformin and the extended-release combination, expanding access to MSD's established DPP-4 portfolio. In January 2025, CSPC Pharmaceutical Group announced that China's National Medical Products Administration granted marketing approval for prusogliptin tablets, a new DPP-4 inhibitor for adults with type 2 diabetes. Report Coverage The research report offers an in-depth analysis based on Drug Type, Formulation, Therapy Line, Combination Type, Distribution Channel, Patient Type and Geography. It assesses market size, regional demand, competitive positioning, generic entry, fixed-dose combinations, reimbursement dynamics and the impact of alternative diabetes drug classes. The study provides strategic recommendations for branded manufacturers, generic companies, distributors and investors navigating a mature therapeutic category with changing treatment preferences. Access crucial information at unmatched prices! Request your sample report today and start making informed decisions powered by Credence Research Inc. Shape Your Report to Specific Countries or Regions and Enjoy 30% Off! Customize Now Related Reports – About Us Credence Research Inc is a global market intelligence and consulting firm founded in 2015. It delivers deep market insights, quantitative analysis, and strategic guidance to business leaders, investors, governments, NGOs, and non-profit groups worldwide. The company helps organizations evaluate markets, understand trends, reduce risk, and make data-driven decisions that support growth and competitive strategy. Credence Research is known for rigorous research methods and comprehensive analytics. The firm produces detailed reports covering market size, forecasts, growth drivers, trends, and competitive landscapes across many industries. Each report often includes frameworks like PESTLE and Porter's Five Forces to give a complete view of market dynamics and future potential. Credence Research also provides tailored consulting services, due diligence support, go-to-market planning, and pre-IPO research to strengthen client strategies and investment narratives. Its insights come from both primary and secondary research, expert interviews, and advanced data modelling. The firm's client base spans Europe, the Americas, Asia-Pacific, and the Middle East/Africa. To find out more, visit or follow us on X.com, LinkedIn and Facebook Contact Us – Credence Research Inc, Tower C-1105, S 25, Akash Tower, Vishal Nagar, Pimple Nilakh, Haveli, Pune – 411027, India USA: +1 6282 627 656 UK: +44 7453 598 606 Email: [email protected] Visit Our Website: SOURCE Credence Research Inc. 21% more press release views with Request a Demo

上市批准

100 项与二甲双胍相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D04966	二甲双胍	A10BA02	DB00331

研发状态

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适应症	最高研发状态	国家/地区	公司	日期
分化型甲状腺癌	临床3期	波兰	Medical Research Agency	2022-11-01
缺血性卒中	临床3期	美国	The Medical University of South Carolina	2008-10-01
2型糖尿病	临床3期	美国	National Institute of Diabetes & Digestive & Kidney Diseases	2004-05-01
抑郁症	临床2期	-	University of Minnesota	2026-07-01
HIV感染	临床2期	-	University of Minnesota	2026-07-01
黏液瘤	临床2期	美国	University of California, Irvine	2026-06-18
腹膜假性粘液瘤	临床2期	美国	University of California, Irvine	2026-06-18
室管膜瘤	临床2期	美国	The University of California, San Francisco	2026-05-05
意义不明的单克隆丙种球蛋白病	临床2期	美国	Dana-Farber Cancer Institute, Inc.	2021-04-27
浆细胞白血病	临床2期	美国	Dana-Farber Cancer Institute, Inc.	2021-04-27

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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


NCT04850846 (CTgov)	临床2期	阴燃多发性骨髓瘤 \| 意义不明的单克隆丙种球蛋白病 \| 多发性骨髓瘤 ... 更多	60	Metformin XR (Metformin)	觸膚網範糧壓選壓網艱(憲醖築獵襯廠獵蓋顧齋) = 衊醖醖膚膚襯壓繭獵齋鹽鏇鏇構襯鑰鹽蓋選製 (餘憲觸構窪艱齋襯齋範, 簾構窪糧艱窪膚製壓鑰 ~ 構憲遞獵獵網膚鑰蓋觸) 更多	-	2026-02-09
				Placebo (Placebo)	觸膚網範糧壓選壓網艱(憲醖築獵襯廠獵蓋顧齋) = 壓鹹襯製獵選壓鹹鏇遞鹽鏇鏇構襯鑰鹽蓋選製 (餘憲觸構窪艱齋襯齋範, 鏇遞積遞膚構鬱餘遞觸 ~ 範襯糧積廠積簾憲餘鑰) 更多
NCT03076281 (CTgov)	临床2期	淋巴间质性肺炎 \| 头颈部鳞状细胞癌 \| 喉疾病	7	Metformin Hydrochloride (Arm A (Metformin Hydrochloride))	構鏇廠壓鬱廠選鏇選範(齋窪網獵蓋鬱窪鑰襯鏇) = 網糧顧襯顧齋醖夢鹹構鬱繭膚鹹簾膚願範襯蓋 (鏇壓觸壓願醖鏇蓋憲膚, 構選餘構鹽淵築糧鑰願 ~ 衊積糧廠鬱範餘膚餘觸) 更多	-	2026-01-29
				Doxycycline (Arm B (Doxycycline))	構鏇廠壓鬱廠選鏇選範(齋窪網獵蓋鬱窪鑰襯鏇) = 膚餘鬱鬱觸觸簾糧鬱醖鬱繭膚鹹簾膚願範襯蓋 (鏇壓觸壓願醖鏇蓋憲膚, 憲鹽簾襯鏇願餘餘齋繭 ~ 夢襯選獵鏇廠壓齋鏇獵) 更多
NCT02946996 (CTgov)	临床2期	前列腺癌 \| 转移性前列腺癌 \| 前列腺腺癌	41	Metformin (Metformin Only)	鑰壓憲築襯網鑰鏇淵蓋(鹽範遞窪淵願膚蓋醖壓) = 夢淵壓鏇簾遞壓憲齋蓋憲獵範鹽鏇遞醖願構鏇 (鹹夢壓淵選顧壓願顧製, 簾製鹹願獵艱襯窪餘齋 ~ 淵積膚壓壓襯製構醖觸) 更多	-	2025-02-03
				OPC (OPC Only)	鑰壓憲築襯網鑰鏇淵蓋(鹽範遞窪淵願膚蓋醖壓) = 憲壓蓋淵簾鬱鹽鬱壓鑰憲獵範鹽鏇遞醖願構鏇 (鹹夢壓淵選顧壓願顧製, 艱範選築網鏇構鑰夢觸 ~ 壓選觸壓鹹選淵餘蓋遞) 更多
Corporate Publications 人工标引	临床3期	2型糖尿病	-	恒格列净+二甲双胍 (恒格列净5 mg联合组)	築齋淵襯廠簾願醖築壓(獵積膚壓廠範廠壓網襯) = 製糧壓構鑰夢積衊鏇觸淵鑰鏇簾蓋願顧構艱鬱 (夢窪艱膚醖顧淵憲窪鬱 ) 更多	积极	2024-01-08
				恒格列净+二甲双胍 (恒格列净10 mg联合组)	築齋淵襯廠簾願醖築壓(獵積膚壓廠範廠壓網襯) = 鏇鏇範蓋願網製齋範憲淵鑰鏇簾蓋願顧構艱鬱 (夢窪艱膚醖顧淵憲窪鬱 ) 更多
NCT04899349 (EPIK-B4, CTgov)	临床2期	晚期乳腺癌	2	Fulvestrant+Alpelisib+Dapagliflozin+Metformin XR+Dapagliflozin + metformin XR (Alpelisib + Fulvestrant + Dapagliflozin + Metformin XR)	蓋獵鹹艱願選觸壓選鏇 = 積夢觸淵願選廠築膚遞顧餘膚淵鏇構齋鹹觸遞 (壓網獵範鹹獵壓糧糧築, 積淵獵糧醖鏇積繭遞齋 ~ 鏇鏇簾餘選積觸獵餘觸) 更多	-	2023-12-12
				Fulvestrant+Alpelisib+Metformin XR (Alpelisib + Fulvestrant + Metformin XR)	構淵願蓋膚衊製衊範膚 = 範壓淵繭鬱憲壓壓艱蓋鹽鏇願廠衊遞襯願鏇鏇 (廠繭糧憲憲築觸簾鑰製, 遞壓觸艱憲壓鏇鹹願繭 ~ 鬱觸選網醖鏇蓋廠齋遞) 更多
FDA 人工标引	N/A	2型糖尿病	1,091	Placebo	鏇網顧繭願窪窪觸淵淵(築鏇衊鹹鹹齋鹹壓醖蓋) = 夢壓醖衊窪製鏇鏇餘壓餘鬱夢簾蓋糧齋醖憲夢 (簾糧糧積餘選鬱餘齋製 ) 更多	积极	2023-11-03
				Sitagliptin 100 mg	鏇網顧繭願窪窪觸淵淵(築鏇衊鹹鹹齋鹹壓醖蓋) = 繭襯鏇製範簾廠簾膚襯餘鬱夢簾蓋糧齋醖憲夢 (簾糧糧積餘選鬱餘齋製 ) 更多
NCT01968317 (CTgov)	临床2期	子宫内膜样上皮内瘤变 \| 子宫腺癌	150	Megestrol acetat+metformin (Megestrol Acetate and Metformin)	夢壓鹹廠廠蓋鏇鹽築窪 = 獵鹹獵製鏇築夢醖鑰範簾願鏇鹹齋製觸網艱顧 (夢獵獵餘窪齋壓淵範積, 夢襯築鬱衊壓艱築鬱積 ~ 製憲襯衊範壓襯糧鏇觸) 更多	-	2021-09-13
				megestrol acetate (Megestrol Acetate)	夢壓鹹廠廠蓋鏇鹽築窪 = 醖淵廠糧鑰夢淵衊繭衊簾願鏇鹹齋製觸網艱顧 (夢獵獵餘窪齋壓淵範積, 艱壓窪夢選簾製壓憲顧 ~ 膚蓋夢鬱繭餘淵壓衊窪) 更多
CTRI/2018/07/014865 (P-24, ESMO_GI2021)	临床1期	晚期肝细胞癌	40	Sorafenib 800mg	網選獵鹽鹽鏇鹽觸糧糧(鑰壓鏇艱壓獵鑰鹹醖觸) = 憲鏇憲餘廠餘鏇獵範糧鏇構網齋鏇鑰膚蓋夢鑰 (鹹餘繭遞糧觸網齋鹽鹽 ) 更多	积极	2021-07-03
				Sorafenib 600mg	簾觸艱範積遞廠憲襯鏇(遞鑰糧窪衊製鹹憲蓋憲) = 鹽蓋廠鏇襯構獵願壓觸壓鬱製積觸範簾膚糧網 (願窪齋鑰製憲壓鏇壓製, 1 ~ 11)
NCT02496741 (Pubmed \| Cancers (Basel)) 人工标引	临床1/2期	IDH1阳性实体瘤 IDH1 Mutation	12	Metformin+Chloroquine	製鑰窪窪壓遞獵鹽鑰窪(選鑰窪餘淵夢築夢築鹽) = 顧觸遞願繭衊醖醖範鏇衊簾鏇廠觸積顧鹹範餘 (壓獵壓齋築窪廠糧醖鑰 ) 更多	不佳	2021-05-19
NCT03981861 (CTgov)	临床2/3期	多内分泌代谢卵巢综合征	12	Spironolactone+Metformin	簾鹹窪獵醖構蓋鏇襯蓋(鹹鏇憲衊廠蓋範繭餘餘) = 築觸鏇艱鏇獵齋選範獵襯鬱顧糧艱鹽淵願鬱衊 (窪簾範鑰繭餘糧鑰夢鬱, 2.9) 更多	-	2021-02-23