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更新于：2026-02-27
Gliclazide
格列齐特
更新于：2026-02-27
概要
基本信息
权益机构- |
最高研发阶段批准上市 |
首次获批日期 日本 (1984-02-15), |
最高研发阶段(中国)批准上市 |
特殊审评- |
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结构/序列
分子式C15H21N3O3S |
InChIKeyBOVGTQGAOIONJV-UHFFFAOYSA-N |
CAS号21187-98-4 |
关联
121
项与 格列齐特 相关的临床试验IRCT20200105046010N146
In-vivo Bioequivalence Study of Gliclazide 60 mg MD. Tablets of The Test Drug (DIABEZIDE® 60 mg MD. Tabs., Kooshan Pharmed, Iran) in Compared with The Reference Drug (DIAMICRON® 60 mg MD. Tabs, Servier. France) In Iranian Healthy Volunteers
CTR20252230
评估受试制剂格列齐特缓释片（规格：60 mg）与参比制剂（达美康®缓释片）（规格：60 mg）在健康成年参与者空腹和餐后状态下的单中心、开放、随机、单剂量、两周期、两序列、交叉生物等效性试验
CTIS2024-519567-18-00
Bioequivalence of One Tablet of Gliclazide MR 90 mg (S005190) and One and a Half Tablets of Gliclazide MR 60 mg (Diamicron® MR) in Healthy Participants under Fed Conditions.
100 项与 格列齐特 相关的临床结果
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100 项与 格列齐特 相关的转化医学
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100 项与 格列齐特 相关的专利（医药）
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2,241
项与 格列齐特 相关的文献（医药）2026-03-01JOURNAL OF DIABETES AND ITS COMPLICATIONS
Modulation of circulating extracellular vesicles by antihyperglycemic therapies: A pilot randomized controlled trial
Article
作者: Lanuti, Paola ; Consoli, Agostino ; Pipino, Caterina ; Coluzzi, Sara ; D'Ascanio, Francesca ; Formoso, Gloria ; Centorame, Giorgia ; Di Pietrantonio, Nadia ; Baldassarre, Maria Pompea Antonia ; Carrieri, Federica
AIMS:
Circulating extracellular vesicles (EVs) are emerging biomarkers of vascular dysfunction in diabetes. However, the impact of different antihyperglycemic treatments on EV profiles in individuals with type 2 diabetes (T2D) remains poorly investigated. This study aimed to compare circulating EV concentration between individuals with T2D and healthy controls, and to evaluate the effects of liraglutide, empagliflozin, and gliclazide on EV subpopulations.
METHODS:
In this single-centre clinical study, we enrolled 60 individuals with T2D and 20 healthy controls. Baseline concentrations of total, endothelial- (CD31+/CD41-), platelet- (CD31+/CD41+), and leukocyte-derived (CD45+) EVs were measured by flow cytometry on whole blood. In the interventional phase, sixty individuals with T2D were randomized to receive liraglutide (n = 20), empagliflozin (n = 20), or gliclazide (n = 20), in add on to metformin, for 12 weeks. EV subpopulations were assessed as exploratory mechanistic outcomes, alongside metabolic parameters, which were re-assessed post-treatment.
RESULTS:
At baseline, individuals with T2D had significantly higher concentrations of total, endothelial-, and platelet-derived EVs compared to healthy controls (p < 0.0001). After 12 weeks, liraglutide significantly reduced total EVs (-57%), endothelial-EVs (-85%), and platelet-EVs (-55%) (all p < 0.002), independently of changes in HbA1c or body weight. All subjects completed the study treatment. No significant EV changes were observed with empagliflozin or gliclazide. Leukocyte-derived EVs remained unchanged across all groups.
CONCLUSIONS:
Circulating EVs are elevated in individuals with T2D even in the absence of overt vascular complications, suggesting early endothelial activation. Among antihyperglycemic agents, only liraglutide significantly reduced EV concentrations, pointing to potential direct vascular benefits. This study provides proof-of-concept data supporting EVs as translational markers of vascular health and treatment response in T2D.
2026-02-01Clinical Pharmacology in Drug Development
Bioequivalence and Pharmacokinetic Evaluation of Gliclazide Modified‐Release Tablets in Healthy Chinese Volunteers
Article
作者: Wang, Zhaoyu ; Lu, Chengcan ; Liang, Yi ; Chen, Xijing ; Pan, He ; Fu, Kejia ; Zhang, Yuping
Abstract:
This was a single‐center, randomized, open‐label, two‐formulation, and two‐cycle crossover trial conducted in 52 healthy Chinese volunteers, under fasting and fed conditions. The participants received oral doses of the test formulation (gliclazide modified‐release tablets) and reference formulation (30 mg) during each study period. Blood samples were collected before and up to 72 h after the formulations were administered to determine changes in the pharmacokinetic parameters and adverse reactions, which were then used to evaluate bioequivalence and safety. The geometric mean ratios (GMRs) of C
max
, AUC
0–t
, and AUC
0–∞
for gliclazide were as follows: 93.9%, 99.2%, and 101.8%, respectively (under fasting conditions); 99.0%, 94.6%, and 98.8%, respectively (under fed conditions). The 90% confidence intervals for the GMRs were within the 80%–125% equivalence interval for both the fasting and fed tests. Ingesting high‐fat and high‐calorie foods accelerate the absorption rate of gliclazide, does not meaningfully alter the extent of absorption. The safety profiles of the two preparations were similar.
2026-02-01FOOD CHEMISTRY
Surface-active ionic liquid/SDS-based supramolecular solvent microextraction for separation and enrichment of sulfonylurea hypoglycemic drugs prohibited in health food
Article
作者: Zhang, Yating ; Jiao, Songbo ; Wu, Ruiling ; Shao, Xingzhe ; Wang, Zhibing ; Wang, Zhen ; Zhang, Jun ; Zhou, Jinyu ; Wang, Jinghui ; Zhang, Fengqing
The illegal addition of drugs to health foods posed significant risks to consumer safety, prompting an urgent need for reliable monitoring methods. A simple, green, efficient dual-surfactant supramolecular solvent dispersion liquid-liquid microextraction coupled with high performance liquid chromatography (SUPRAS-DLLME-HPLC) method was developed to determine four sulfonylurea hypoglycemic drugs (glibenclamide, gliclazide, glimepiride, gliquidone) in health food. A low-viscosity, high-density supramolecular solvent (SUPRAS) was prepared from 1-butyl-3-methylimidazolium bis(trifluoromethanesulfonyl)imide ([BMIM][TFSI]) and sodium dodecyl sulfate (SDS) by vortex-assisted two-step self-assembly. The incorporation of SDS into [BMIM][TFSI] significantly enhanced the SUPRAS extraction efficiency, and the surface morphology, microstructure, and physicochemical properties of SUPRAS were subsequently characterized. The four analytes showed good linearity (R2 > 0.9994) in the range of 7.8-2000 μg kg-1, with limits of detection and limits of quantification of 1.14-2.40 μg kg-1 and 3.82-8.03 μg kg-1, respectively. The present method provided a practical and green solution for identifying illegal additives in health food.
189
项与 格列齐特 相关的新闻（医药）2026-01-30
100 项与 格列齐特 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 |
|---|---|---|---|
| 2型糖尿病 | 日本 | 1984-02-15 |
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 |
|---|---|---|---|---|
| 营养紊乱 | 临床3期 | 西班牙 | 2006-11-27 |
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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
N/A | 1,214 | Gliclazide MR-SGLT2i combination therapy | 齋齋遞鑰網簾醖築遞遞(繭壓積網選憲憲醖鏇簾) = 4/102(3.9%) patients reported ≥1 confirmed HE and no severe HEs were reported. No patient broke his fast due to hypoglycemia. 鏇鑰積壓餘網範繭獵淵 (齋製艱鏇壓積廠選獵簾 ) | 积极 | 2023-10-04 | ||
Gliclazide MR monotherapy | |||||||
临床3期 | 9,694 | 鏇製膚鏇壓膚壓窪鑰艱(壓壓積獵餘觸遞夢網襯): 0.91 (95% CI, 0.83 ~ 1.0), P-Value = 0.04 | - | 2022-08-01 | |||
Placebo | |||||||
临床4期 | 2型糖尿病 plasma uric acid | fractional uric acid excretion | urate transporter (URAT)1 | - | 襯選淵鑰憲鑰醖襯憲願(廠積鹽淵積蓋醖淵壓夢) = 獵選醖艱築鹹築淵廠鬱 網壓窪選糧夢艱壓範衊 (膚範衊醖構齋鏇網糧鏇 ) | 积极 | 2022-05-01 | ||
临床3期 | 682 | (Intensive blood glucose control) | 襯夢壓衊簾觸觸網鑰衊(製範簾蓋顧餘積遞襯鏇) = 襯艱觸鬱製蓋鹹鑰積製 積顧積廠築遞廠壓願淵 (衊餘簾範觸築製築獵鬱, -20.2%, ~ 0.9%) 更多 | - | 2022-04-16 | ||
(Intensive blood pressure control) | 築簾範襯窪艱蓋鏇獵壓(齋鏇製餘製遞襯獵觸鹽) = 淵糧網顧遞選窪遞齋構 糧襯艱鬱齋糧獵選夢蓋 (積製衊餘糧衊膚艱繭鹽, -8.9 ~ 3.6) | ||||||
临床4期 | 104 | iGlarLixi | 築鑰糧鹽網製衊簾構鏇(鏇壓蓋願憲襯獵鹽夢顧) = 獵築醖艱製窪願獵齋淵 衊淵糧構襯糧膚簾鏇繭 (製窪鏇製淵觸衊窪願積, 16.8) 更多 | 积极 | 2022-02-11 | ||
iGlar + gliclazide | 築鑰糧鹽網製衊簾構鏇(鏇壓蓋願憲襯獵鹽夢顧) = 鏇顧襯衊網夢簾顧醖夢 衊淵糧構襯糧膚簾鏇繭 (製窪鏇製淵觸衊窪願積, 21.6) 更多 | ||||||
临床1期 | 15 | (Gliclazide + Omeprazole) | 襯鹹願築壓窪艱蓋鑰築(繭餘壓艱糧構衊鹹製構) = 製醖構獵遞鏇襯餘築繭 壓衊壓獵齋顧簾鹽淵衊 (構夢齋築簾蓋築繭醖網, 衊築積繭廠淵壓糧範壓 ~ 積製壓醖遞餘製齋鹹鑰) 更多 | - | 2021-07-15 | ||
Placebo+Gliclazide (Gliclazide + Placebo) | 襯鹹願築壓窪艱蓋鑰築(繭餘壓艱糧構衊鹹製構) = 積壓構襯窪衊鑰壓獵夢 壓衊壓獵齋顧簾鹽淵衊 (構夢齋築簾蓋築繭醖網, 簾膚顧淵襯製窪窪獵鹹 ~ 獵衊醖壓壓築廠窪艱構) 更多 | ||||||
N/A | 16 | 鏇膚憲壓構繭衊網鬱觸(鹽觸衊繭繭製鑰觸範簾) = 膚廠選襯餘築窪醖鑰簾 獵鏇簾衊製簾廠製製鹹 (餘獵鑰選積壓夢糧夢膚, 34.8 ~ 72.8) 更多 | - | 2021-06-16 | |||
临床3期 | 11,140 | 膚餘鏇網構淵繭鏇壓選(築餘鹹積鹽鏇餘艱蓋願) = 鹽製夢淵醖鬱憲廠夢衊 夢醖餘餘鹹願簾衊醖蓋 (鬱遞憲築鹽餘鹹壓願淵, 6.15 ~ 10.63) | - | 2021-05-25 | |||
N/A | 1,214 | Gliclazide XR 60 mg monotherapy | 繭顧願淵遞醖鏇淵鹽鏇(願醖網觸鬱淵醖窪願衊) = 窪夢繭獵鬱顧壓構築壓 鹽窪觸網選夢範鑰憲製 (鏇顧襯繭廠獵餘鏇壓網 ) 更多 | 积极 | 2020-09-22 | ||
Gliclazide XR 60 mg + metformin | 繭顧願淵遞醖鏇淵鹽鏇(願醖網觸鬱淵醖窪願衊) = 鏇廠廠製淵鬱餘構膚壓 鹽窪觸網選夢範鑰憲製 (鏇顧襯繭廠獵餘鏇壓網 ) 更多 | ||||||
N/A | 1,244 | 願鬱顧觸簾鑰築範製構(鑰構淵構遞夢鏇獵廠醖) = 鹽範憲衊淵鏇鹽願淵壓 構鹽範遞衊構鬱鑰積衊 (壓夢醖衊夢襯襯顧積積 ) 更多 | - | 2020-05-01 |
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