更新于：2024-06-21
Mitiglinide Calcium Hydrate
米格列奈钙
更新于：2024-06-21
概要
基本信息
药物类型 小分子化药 |
别名 Glinsuna、Mitiglinide、Mitiglinide calcium + [10] |
作用机制 KATP通道阻滞剂 |
治疗领域 |
在研适应症 |
非在研适应症 |
非在研机构 |
最高研发阶段批准上市 |
首次获批日期 日本 (2004-01-29), |
最高研发阶段(中国)批准上市 |
特殊审评- |
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结构
分子式C38H54CaN2O8 |
InChIKeyGJJVODCYSACLPP-UZYHXJQGSA-N |
CAS号207844-01-7 |
关联
43
项与 米格列奈钙 相关的临床试验米格列奈钙片随机、开放、交叉设计在中国健康受试者中的生物等效性正式试验
米格列奈钙片(10mg)在健康受试者中的生物等效性试验
米格列奈钙片在健康人体中的随机、开放、交叉设计、四周期高脂餐后口服生物等效性试验
100 项与 米格列奈钙 相关的临床结果
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100 项与 米格列奈钙 相关的转化医学
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100 项与 米格列奈钙 相关的专利（医药）
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147
项与 米格列奈钙 相关的文献（医药）2024-04-01Journal of diabetes investigation
Comparative effects of fixed‐dose mitiglinide/voglibose combination and glimepiride on vascular endothelial function and glycemic variability in patients with type 2 diabetes: A randomized controlled trial
Article
作者: Saito, Momo ; Tanaka, Yoshiya ; Tanaka, Kenichi ; Sonoda, Satomi ; Tomoyose, Yukiko ; Uemura, Fumi ; Hori, Yuri ; Tokutsu, Akemi ; Okada, Yosuke ; Umezu, Saeko ; Hashimoto, Ryoma ; Kurozumi, Akira ; Tateyama, Rina
ABSTRACT:
Introduction:
The aim of this study was to compare the effects of mitiglinide/voglibose with those of glimepiride on glycemic variability and vascular endothelial function in patients with type 2 diabetes.
Materials and Methods:
It was a multicenter, open‐label, randomized, crossover study. Hospitalized patients received either mitiglinide/voglibose (three times daily administration of 10 mg mitiglinide and 0.2 mg voglibose) or glimepiride (once‐daily 2 mg) in random order, each for 5 days. The reactive hyperemia index (RHI) and the mean amplitude of glycemic excursions (MAGE) were measured as co‐primary endpoints using reactive hyperemia peripheral arterial tonometry and continuous glucose monitoring.
Results:
The analysis included 30 patients (15 in each group). The RHI was 1.670 ± 0.369 during treatment with mitiglinide/voglibose and 1.716 ± 0.492 during treatment with glimepiride, with no significant difference between the two. MAGE was significantly lower in the mitiglinide/voglibose group (47.6 ± 18.5 mg/dL) than in the glimepiride group (100.6 ± 32.2 mg/dL). Although the mean blood glucose levels over the entire 24 h period were comparable between the two groups, the use of mitiglinide/voglibose was associated with a lower standard deviation of mean glucose, coefficient of variation, and mean postprandial glucose excursion compared with glimepiride. The time below range (<70 mg/dL) and the time above range (>180, >200, and 250 mg/dL) were lower in the mitiglinide/voglibose group, while the time in range (70–180 mg/dL) was higher.
Conclusions:
In our short‐duration randomized crossover study, although not impacting vascular endothelial function, mitiglinide/voglibose demonstrated potential benefits in reducing glycemic variability, postprandial hyperglycemia, and hypoglycemia in patients with type 2 diabetes.
2024-01-01Diabetology international
The efficacy of switching basal–bolus insulin therapy to basal insulin-supported oral therapy with a glinide and an α-glucosidase inhibitor in patients with type 2 diabetes depends on insulin secretory capacity, but not on blood glucose profiles and insulin dosages prior to the switching
Article
作者: Asano-Hayami, Emi ; Nakai-Shimoda, Hiromi ; Naito, Ena ; Yura-Miura, Emiri ; Hayami, Tomohide ; Kawai, Miyuka ; Yamada, Yuichiro ; Nakamura, Jiro ; Ando, Toshihito ; Ejima, Yohei ; Kojima, Chika ; Ishikawa, Takahiro ; Kato, Makoto ; Himeno, Tatsuhito ; Kamiya, Hideki ; Tsunekawa, Shin ; Asada-Yamada, Yuriko ; Kondo, Masaki ; Kato, Yoshiro ; Kasagi, Rina ; Sugiura-Roth, Yukako ; Asano, Saeko ; Motegi, Mikio ; Nagao, Eriko
Aims:
We aimed to identify patients who would benefit from basal insulin-supported oral therapy (BOT) with a glinide and an α-glucosidase inhibitor (a fixed-dose combination tablet of mitiglinide 10 mg and voglibose 0.2 mg) in Japanese type 2 diabetic patients.
Methods:
Patients who were hospitalized to improve hyperglycemia received basal-bolus insulin therapy. After the reduction of glucose toxicity, a 75 g oral glucose tolerance test and a glucagon test were performed. Thereafter, the basal-bolus insulin therapy was switched to BOT with mitiglinide, followed by further addition of voglibose. Interstitial glucose levels were continuously monitored throughout the study period. Diurnal glucose profile was recorded and analyzed. Patients were divided into two groups according to whether their percentage of time in range (TIR, 70-180 mg/dL) under BOT with mitiglinide/voglibose was higher than 70% or not, and the differences in clinical characteristics between the groups were analyzed.
Results:
Twenty patients were enrolled, and 19 of them completed the study. BOT with mitiglinide/voglibose achieved ≥ 70% of TIR in thirteen patients. The area under the curve of serum C-peptide levels during the oral glucose tolerance test was significantly higher in the patients with ≥ 70% of TIR. The daily insulin dosages and blood glucose profiles were comparable between the two groups.
Conclusions:
The efficacy of BOT with mitiglinide/voglibose depended on residual insulin secretory abilities. This therapy would be a useful therapeutic option for patients with type 2 diabetes.
2024-01-01Saudi pharmaceutical journal : SPJ : the official publication of the Saudi Pharmaceutical Society
Preparation, in vitro and in vivo evaluation of a novel mitiglinide microemulsions
Article
作者: Wang, Miaomiao ; Li, Hanghang ; Yang, Wenzhi
This study aimed to prepare an o/w mitiglinide microemulsion (MTGME) to improve the drug solubility and bioavailability. The formulation of o/w MTGME was optimized by the solubility study of drug, pseudo-ternary phase diagram and Box-Behnken design successively. MTGME was characterized by dynamic laser light scattering (DLS), zeta potential and transmission electron microscopy (TEM), moreover, the storage stability, pharmacodynamics and pharmacokinetics were investigated. The optimal prescription for MTGME consisted of Maisine 35-1 (oil), Cremophor EL (surfactant) and propylene glycol (PG, cosurfactant). MTGME with a spherical dimension of 58.1 ± 5.86 nm was stable when stored at 4 °C for 3 months. The blood glucose levers (BGL) of diabetic mice were uniformly and significantly decreased by intragastric (i.g.) administration of 1-4 mg/kg MTGME, in which BGL (i.g. 4 mg/kg MTGME) was reduced by 69% during 24 h. The pharmacokinetics study of MTGME (i.g., 20 mg/kg) in Wistar rats showed higher plasma drug concentration (Cmax, 2.9 folds), larger area under curve (AUC, 4.6 folds) and oral bioavailability than those of MTG suspensions. Generally, the MTGME (o/w) showed good effect on controlling hyperglycemia. Therefore, microemulsion can be used as an effective oral drug delivery system to improve the bioavailability of MTG.
100 项与 米格列奈钙 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 | 2004-01-29 |
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 |
|---|---|---|---|---|
| 非胰岛素依赖型糖尿病2 | 临床3期 | - | 2006-08-01 | |
| 内分泌系统疾病 | 临床1期 | 中国 | 2012-11-14 |
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临床结果
临床结果
适应症
分期
评价
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临床4期 | 178 | Insulin+KAD-1229 (Placebo/KAD-1229) | 淵積衊獵廠淵蓋糧壓構(襯選夢網鑰遞鏇網顧餘) = 壓齋簾壓網鬱鑰築蓋觸 繭齋壓築鬱淵積糧鹹壓 (構遞顧鬱簾鏇艱憲構簾, 鹹顧艱壓積選壓壓鹽艱 ~ 網鬱積構築襯鏇廠範願) | - | 2019-09-06 | ||
Insulin+KAD-1229 (KAD-1229/KAD-1229) | 淵積衊獵廠淵蓋糧壓構(襯選夢網鑰遞鏇網顧餘) = 築觸膚鹽製醖夢齋膚壓 繭齋壓築鬱淵積糧鹹壓 (構遞顧鬱簾鏇艱憲構簾, 製構醖簾顧觸簾淵糧鏇 ~ 淵鹹餘壓繭壓範鬱淵淵) | ||||||
临床3期 | 156 | insulin glargine+mitiglinide | 構築鬱醖窪膚積窪構憲(蓋顧觸觸廠膚鏇淵繭製) = 網廠構繭選選鏇築齋餘 餘醖壓獵鬱廠鬱蓋齋壓 (鬱願觸願餘淵齋製繭膚 ) | 非劣 | 2015-01-01 | ||
insulin glargine+voglibose | 構築鬱醖窪膚積窪構憲(蓋顧觸觸廠膚鏇淵繭製) = 艱築壓膚築襯廠膚襯積 餘醖壓獵鬱廠鬱蓋齋壓 (鬱願觸願餘淵齋製繭膚 ) | ||||||
临床1期 | 26 | 憲顧顧齋範糧衊網鬱艱(鏇壓窪積獵鹽簾膚膚網) = 淵積簾網襯膚襯鬱蓋衊 餘築製顧選壓襯淵顧構 (鬱獵獵鹽遞製衊糧選製 ) | 积极 | 2013-11-01 | |||
憲顧顧齋範糧衊網鬱艱(鏇壓窪積獵鹽簾膚膚網) = 製遞醖餘壓簾夢壓製淵 餘築製顧選壓襯淵顧構 (鬱獵獵鹽遞製衊糧選製 ) | |||||||
N/A | 9 | 廠選鹹觸築糧遞窪鹽憲(簾夢構夢築構顧憲築鑰) = 壓構繭醖簾醖遞鏇窪簾 襯淵衊襯窪憲鬱範廠窪 (糧鏇餘窪膚範製膚鹽遞, 24.7) | - | 2012-10-03 | |||
廠選鹹觸築糧遞窪鹽憲(簾夢構夢築構顧憲築鑰) = 鬱選鹹衊艱窪築糧簾鬱 襯淵衊襯窪憲鬱範廠窪 (糧鏇餘窪膚範製膚鹽遞, 30.1) |
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