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更新于：2026-05-09
Metformin Hydrochloride
盐酸二甲双胍
更新于：2026-05-09
概要
基本信息
简介盐酸二甲双胍，商品名为GLUCOPHAGE，用于治疗2型糖尿病。它于1957年在法国首次获批，现在由Bristol Myers Squibb公司生产。GLUCOPHAGE通过激活PRKAB1，帮助改善10岁及以上成人和儿童患者的血糖控制，配合饮食和运动使用。该药物属于双胍类药物，通常用作辅助疗法，帮助管理2型糖尿病患者的血糖水平。 |
药物类型 小分子化药 |
别名 Meiformin Hydrochloride、Metformin hydrochloride (JP17/USP)、Metformin Hydrochlorride + [67] |
靶点 |
作用方式 激活剂 |
作用机制 PRKAB1激活剂(腺苷酸活化蛋白激酶亚基β1激活剂) |
非在研适应症 |
最高研发阶段批准上市 |
首次获批日期 中国 (1992-01-01), |
最高研发阶段(中国)批准上市 |
特殊审评优先审评 (中国) |
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结构/序列
分子式C4H12ClN5 |
InChIKeyOETHQSJEHLVLGH-UHFFFAOYSA-N |
CAS号1115-70-4 |
关联
2,839
项与 盐酸二甲双胍 相关的临床试验CTRI/2025/09/094234
A Feasibility Study Comparing a Unani Regimen and Metformin in the management of Type 2 Diabetes Mellitus - NIL
NCT07511010
A Phase I Clinical Study to Assess the Food Effect and Multiple Dose Pharmacokinetic of Chiglitazar/Metformin Extended-Release Fixed Dose Combination Tablets
NCT07275359
Investigating Senolytic Properties in Pulmonary Rehabilitation and Metformin in COPD Exacerbations
100 项与 盐酸二甲双胍 相关的临床结果
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100 项与 盐酸二甲双胍 相关的转化医学
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100 项与 盐酸二甲双胍 相关的专利（医药）
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18,151
项与 盐酸二甲双胍 相关的文献（医药）2026-04-01INTERNATIONAL JOURNAL OF PHARMACEUTICS
At-line to in-line calibration transfer of a NIR PAT model via direct standardization for ribbon porosity monitoring in DoE-driven roller compaction of an extended-release formulation
Article
作者: Dimovski, Riste Popeski ; Geskovski, Nikola ; Lazova, Jelena ; Kukovecz, Ákos ; Antovska, Packa ; Kristó, Katalin ; Atanasova, Ana ; Tóth, Ádám ; Sovány, Tamás ; Gorachinov, Filip
This study combined a D-optimal design of experiments (DoE) to quantify the effects of roller-compaction process parameters on ribbon properties, downstream granule attributes, and extended-release metformin HCl/hydroxypropyl methylcellulose (HPMC) tablet properties, with near infrared-based process analytical technology-guided monitoring implemented via at-line models calibrated across the full DoE-generated porosity range (ε = 9.65-18.73%; DoE model R2 = 0.9365, Q2 = 0.9217). Additionally, micro-computed tomography (MicroCT) was used to elucidate how process settings influence spatial gradients in porosity. Compaction pressure was the primary driver of porosity, while the horizontal screw speed and roll speed controlled feed uniformity, with higher roll speed leading to greater porosity heterogeneity and broader post-milling particle-size distributions. MicroCT supported the DoE results, revealing heterogeneity in pore distribution and orientation, clarifying how microstructure propagates to granule integrity and downstream tablet properties. For porosity monitoring, at-line chemometric models were developed using baseline-oriented preprocessing, zero-order detrending, two-point linear baseline correction, and asymmetric least-squares baseline correction, which provided robust predictions across the explored porosity range (root mean square error of prediction, RMSEP = 0.54-0.59%; R2 = 0.9671-0.9790). These models were successfully transferred to the in-line setting via direct standardization, reducing the need for separate calibration and limiting material consumption during model development.
2026-04-01Journal of Diabetes Investigation
Safety of anagliptin/metformin combination tablets evaluated by non‐inferiority between pre‐ and post‐serum lactic acid levels in Japanese patients with type 2 diabetes and moderate renal impairment (
AMELIO STUDY
)
Article
作者: Toru Kitazawa ; Yasumichi Mori ; Daisuke Takarabe ; Takahisa Tanaka ; Mitsuhiko Noda ; Hiroshi Kajio ; Ryotaro Bouchi ; Masanori Yamazaki ; Hisayuki Katsuyama ; Masahide Okamoto ; Mitsuhisa Komatsu
ABSTRACT:
Aims/Introduction:
To investigate the safety of anagliptin/metformin combination tablets by evaluation of lactic acid levels in Japanese patients with type 2 diabetes and moderate renal impairment.
Materials and Methods:
The participants of type 2 diabetes with creatinine‐based eGFR (eGFRcr) of ≥45 and <60 (mL/min/1.73 m
2
) (Group G3a) received anagliptin/metformin combination LD tablets (anagliptin: 100 mg, metformin hydrochloride: 250 mg/tablet) twice a day for 4 weeks. After 4 weeks, they received anagliptin/metformin combination HD tablets (anagliptin: 100 mg, metformin hydrochloride: 500 mg/tablet) twice daily until after 16 weeks. The participants (Group G3b) with baseline eGFRcr ≥30 and <45 (mL/min/1.73 m
2
) received anagliptin/metformin combination LD tablets twice daily for 16 weeks. The serum lactic acid levels were examined at weeks 4, 8, and 16 after receiving anagliptin/metformin combination tablets.
Results:
The change in serum lactic acid levels from baseline to 16 weeks was −0.09 [−0.28, 0.10] mmol/L (mean [95% confidence intervals]), not exceeding the pre‐specified non‐inferiority margin (0.7 mmol/L). No significant differences occurred in the change in serum lactic acid levels during all observation periods. Serum lactic acid levels exceeded 2.5 mmol/L in four participants (10.5%) and 5.0 mmol/L in one participant (2.6%) during the observation period. No participant had a plasma metformin exceeding 2.5 μg/mL.
Conclusions:
This study demonstrates that the fixed‐dose combination of anagliptin and metformin can be used safely in patients with type 2 diabetes complicated by moderate renal dysfunction. The advantage of this fixed‐dose combination is also considered to be very large.
2026-03-16SPECTROSCOPY LETTERS
Ecological and human health risk assessment of pharmaceutical compounds in the Indian river ecosystem
作者: Ruby, Ruby ; Giri, Arup ; Dimple, Dimple ; Jyoti, Jyoti
Pharmaceutical compounds release into aquatic ecosystem has become a critical problem because they can harm aquatic organisms and humans. Humans may have serious effects due to presence of phamaceuticals in drinking water.This study aims to analyze pharmaceutical compound ecol. and human health risk assessments in thirteen Indian River ecosystems. In this study, various pharmaceuticals, such as ciprofloxacin, norfloxacin, aspirin, carbamazepine, caffeine, and ibuprofen, were detected in different river ecosystems across India. This study aims to analyze the concentrations of pharmaceutical compounds, including the risk quotient (RQ), while performing an ecol. risk assessment.For human health risk assessment, metrics such as acceptable daily intake (ADI) and the risk quotient were employed to assess human health (RQH). The health risk models revealed that the Sirsa River posed significant ecol. threats because RQ greater than 1, whereas the other rivers presented moderate risks. Children were found to be more vulnerable to pharmaceutical intake, and all the rivers presented RQH values exceeding 1 for adults, underscoring serious health concerns.This study will help categorize pharmaceutical compounds and analyze the ecol. and human health risks to water systems. This study provides key insights for policymakers and public health efforts to address pharmaceutical pollution in Indian rivers. It also aligns with the UN Sustainable Development Goals, particularly SDGs 6 and 12.
100 项与 盐酸二甲双胍 相关的药物交易
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研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 糖尿病 | 美国 | 2004-04-27 | |
| 2型糖尿病 | 中国 | 1992-01-01 |
未上市
10 条进展最快的记录, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 浸润性乳腺癌 | 临床3期 | 美国 | 2024-12-16 | |
| 慢性病 | 临床3期 | 美国 | 2020-07-29 | |
| 获得性免疫缺陷综合征 | 临床3期 | 美国 | 2019-02-01 | |
| 腹主动脉瘤 | 临床3期 | 奥地利 | 2018-09-26 | |
| 脆性X综合征 | 临床3期 | 美国 | 2018-04-30 | |
| 脆性X综合征 | 临床3期 | 加拿大 | 2018-04-30 | |
| 代谢综合征 | 临床3期 | 美国 | 2017-08-07 | |
| 非典型增生 | 临床3期 | 美国 | 2015-11-23 | |
| 乳腺癌 | 临床3期 | 美国 | 2015-11-23 | |
| 乳腺增生 | 临床3期 | 美国 | 2015-11-23 |
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临床结果
临床结果
适应症
分期
评价
查看全部结果
临床2期 | 29 | 獵鹹願鹽膚繭鹹窪範遞(醖膚顧壓願壓繭壓壓憲) = 窪夢醖淵衊觸構衊遞襯 顧餘鑰襯鑰憲壓鬱觸獵 (繭鑰觸蓋鏇構製構獵遞, 膚築鬱艱鬱醖觸構鏇鹹 ~ 醖築鹽壓齋淵淵鹽鏇艱) 更多 | - | 2026-04-22 | |||
临床2期 | 111 | Chemotherapy+metformin hydrochloride (Metformin Plus Chemotherapy) | 鑰壓鹽衊顧簾蓋築憲鏇(艱窪顧顧觸鏇積鹽願繭) = 獵範積網鏇糧襯鑰壓淵 築衊簾簾範廠構積齋壓 (範憲憲醖艱願衊夢鏇窪, 餘齋觸築遞衊鑰鬱鬱淵 ~ 選餘鏇鬱網襯糧淵鏇顧) 更多 | - | 2026-03-27 | ||
placebo (Placebo Plus Chemotherapy) | 鑰壓鹽衊顧簾蓋築憲鏇(艱窪顧顧觸鏇積鹽願繭) = 廠觸壓選壓膚餘鹽膚鬱 築衊簾簾範廠構積齋壓 (範憲憲醖艱願衊夢鏇窪, 網衊簾憲醖製遞製醖積 ~ 淵襯製願簾範願艱艱鑰) 更多 | ||||||
临床3期 | 996 | standard of care + metformin | 糧範範艱獵醖遞廠選繭(繭鹹積廠艱糧獵顧醖憲): P-Value = 0.24 更多 | 积极 | 2026-02-26 | ||
standard of care | |||||||
临床2期 | 7 | (Arm A (Metformin Hydrochloride)) | 衊願餘鹹築夢窪選齋窪(繭築鏇齋網簾醖獵觸鹽) = 繭餘憲壓蓋構鏇廠鹽顧 艱廠鏇壓壓築壓願顧築 (鑰鏇鏇醖糧鏇窪艱築衊, 構鑰顧簾襯艱鏇繭構繭 ~ 鹽簾廠構構餘鏇顧範鑰) 更多 | - | 2026-01-29 | ||
(Arm B (Doxycycline)) | 衊願餘鹹築夢窪選齋窪(繭築鏇齋網簾醖獵觸鹽) = 網鑰鏇鬱鬱壓夢蓋製鹹 艱廠鏇壓壓築壓願顧築 (鑰鏇鏇醖糧鏇窪艱築衊, 遞膚鹽繭鹽襯鑰糧廠製 ~ 鑰顧夢觸淵顧壓願淵鹹) 更多 | ||||||
N/A | 28 | (Group 1: Healthy Participants) | 夢構網衊窪鬱餘餘構範(鏇餘餘襯襯壓鹹網壓範) = 鬱繭觸觸願壓襯膚築遞 壓艱製繭壓範製壓餘壓 (艱簾繭襯衊衊壓餘願遞, NA) 更多 | - | 2026-01-13 | ||
(Group 2: F4 Child-Turcotte-Pugh Class A (Child-Pugh A) Subjects (Compensated)) | 夢構網衊窪鬱餘餘構範(鏇餘餘襯襯壓鹹網壓範) = 顧鹹顧醖製齋選觸夢醖 壓艱製繭壓範製壓餘壓 (艱簾繭襯衊衊壓餘願遞, NA) 更多 | ||||||
临床1期 | - | 32 | Dabigatran-etexilate (Dabigatran-etexilate (R)) | 鬱觸鏇夢憲願選鏇繭鑰(糧網觸鑰顧餘膚構鏇蓋) = 繭製獵廠衊夢繭顧鹽膚 襯壓鏇窪簾構觸餘構遞 (鏇觸獵齋膚窪壓鏇齋艱, NA) 更多 | - | 2026-01-09 | |
(Zongertinib and dabigatran-etexilate (T)) | 鬱觸鏇夢憲願選鏇繭鑰(糧網觸鑰顧餘膚構鏇蓋) = 壓選夢築鹽範築鹹廠夢 襯壓鏇窪簾構觸餘構遞 (鏇觸獵齋膚窪壓鏇齋艱, NA) 更多 | ||||||
临床2期 | 早期乳腺癌 estrogen receptor negative (ER-) | HER2+ | 146 | 壓簾願醖淵範糧壓餘網(構壓糧夢糧夢鹹醖顧廠): P-Value = 0.58 更多 | 不佳 | 2025-12-11 | ||
Placebo | |||||||
临床2期 | 13 | Radioactive Iodine+Metformin Hydrochloride (Arm I (metformin hydrochloride)) | 窪醖壓蓋獵鬱醖壓鏇簾(構遞鹹製獵衊壓襯鑰齋) = 廠鏇淵構獵窪願遞鹽願 製願製憲醖築廠選壓網 (網廠鏇繭積簾鑰壓壓襯, 餘鏇鹽壓選膚膚淵構齋 ~ 餘製膚構遞餘簾顧壓製) 更多 | - | 2025-12-11 | ||
Radioactive Iodine (Arm II (placebo)) | 窪醖壓蓋獵鬱醖壓鏇簾(構遞鹹製獵衊壓襯鑰齋) = 觸糧膚糧簾遞選醖遞鹹 製願製憲醖築廠選壓網 (網廠鏇繭積簾鑰壓壓襯, 蓋醖廠構鹹鹽鬱繭願觸 ~ 糧積鏇簾願醖獵廠選醖) 更多 | ||||||
临床3期 | - | 240 | Low-dose COCPs (20 μg ethinyl estradiol/0.15 mg desogestrol) | 構獵膚壓鑰選獵鹹廠餘(網窪膚繭壓醖壓積壓構) = 窪齋鏇積繭網簾壓獵鏇 鬱膚築糧夢膚獵鹹壓壓 (淵醖淵衊夢艱鑰願窪製 ) | 积极 | 2025-12-08 | |
構獵膚壓鑰選獵鹹廠餘(網窪膚繭壓醖壓積壓構) = 醖積繭遞鹹鬱醖醖餘顧 鬱膚築糧夢膚獵鹹壓壓 (淵醖淵衊夢艱鑰願窪製 ) | |||||||
临床1期 | - | 40 | (Part 1: Cocktail) | 艱鏇鏇鏇醖壓網顧築蓋(糧構遞衊醖廠壓構憲願) = 醖獵築餘膚齋憲襯艱鹹 夢鹽醖鏇壓觸廠淵遞鹽 (築構艱鹽鏇憲繭獵簾淵, 21.5) 更多 | - | 2025-12-05 | |
(Part 1: Evobrutinib + Cocktail) | 艱鏇鏇鏇醖壓網顧築蓋(糧構遞衊醖廠壓構憲願) = 齋夢窪衊願選襯淵願遞 夢鹽醖鏇壓觸廠淵遞鹽 (築構艱鹽鏇憲繭獵簾淵, 23.7) 更多 |
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