Delving into the Latest Updates on Mitiglinide Calcium Hydrate with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Glinsuna, Mitiglinide, Mitiglinide calcium

+ [10]

Target

KATP channels

Action

blockers

Mechanism

KATP channels blockers

Therapeutic Areas

Endocrinology and Metabolic Disease

Active Indication

Diabetes Mellitus, Type 2

Inactive Indication

Diabetes Mellitus, Noninsulin-Dependent, 2

Originator Organization

Kissei Pharmaceutical Co., Ltd.

Active Organization

Jiangsu Hansoh Pharmaceutical Co., Ltd.

Shiono Chemical Co. Ltd.

Eisai Co., Ltd.

+ [5]

Inactive Organization

Elixir Pharmaceuticals, Inc.

Shanxi BaoTai Pharmaceutical Co. Ltd.

Drug Highest PhaseApproved

First Approval Date

Japan (29 Jan 2004),

Diabetes Mellitus, Type 2

Regulation-

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Structure/Sequence

Molecular FormulaC38H54CaN2O8

InChIKeyGJJVODCYSACLPP-UZYHXJQGSA-N

CAS Registry207844-01-7

View All Structures (3)

Main purpose: To evaluate the relative bioavailability and bioequivalence of mitiglinide calcium tablets in humans using the certified mitiglinide calcium tablets of Zhejiang Yizeda Pharmaceutical Technology Co., Ltd. as the test preparation and the certified mitiglinide calcium tablets of KISSEI PHARMACEUTICAL CO., LTD. as the reference preparation.

Start Date22 Jan 2024

Sponsor / Collaborator

Zhejiang Yizeda Pharmaceutical Technology Co., Ltd.

CTR20213240

/ CompletedNot Applicable

米格列奈钙片(10mg)在健康受试者中的生物等效性试验

[Translation] Bioequivalence study of mitiglinide calcium tablets (10 mg) in healthy subjects

主要目的：本试验目的是以正大天晴药业集团股份有限公司提供的米格列奈钙片（规格：10 mg/片，正大天晴药业集团股份有限公司生产）为受试制剂，按有关生物等效性试验的规定，与米格列奈钙片（GLUFAST®，规格：10mg/片；KISSEI PHARMACEUTICAL CO., LTD. MATSUMOTO PLANT（橘生药品工业株式会社松本工厂）生产）为参比制剂，进行人体生物等效性试验。次要目的：观察受试制剂米格列奈钙片 10 mg 和参比制剂 GLUFAST® 10 mg 在健康受试者中的安全性。

[Translation]

Primary objective: The purpose of this study is to use Mitiglinide Calcium Tablets (Specification: 10 mg/tablet, produced by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.) provided by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. as the test preparation, and conduct a human bioequivalence study with Mitiglinide Calcium Tablets (GLUFAST®, Specification: 10 mg/tablet; produced by KISSEI PHARMACEUTICAL CO., LTD. MATSUMOTO PLANT) as the reference preparation according to the relevant provisions of bioequivalence tests. Secondary objective: To observe the safety of the test preparation Mitiglinide Calcium Tablets 10 mg and the reference preparation GLUFAST® 10 mg in healthy subjects.

Start Date07 Nov 2022

Sponsor / Collaborator

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

CTR20220245

/ CompletedNot Applicable

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

[Translation] A randomized, open, crossover design, four-period high-fat meal oral bioequivalence study of mitiglinide calcium tablets in healthy volunteers

本试验旨在研究单次餐后口服北京四环科宝制药股份有限公司研制、生产的米格列奈钙片（10 mg）的药代动力学特征；以KISSEI PHARMACEUTICAL CO., LTD. MATSUMOTO PLANT生产的米格列奈钙片（快如妥®，10 mg）为参比制剂，比较两制剂中药动学参数Cmax、AUC0-t、AUC0-∞，评价两制剂的人体生物等效性。

[Translation]

The purpose of this study was to study the pharmacokinetic characteristics of mitiglinide calcium tablets (10 mg) developed and produced by Beijing Sihuan Kebao Pharmaceutical Co., Ltd. after a single oral administration after meal; using mitiglinide calcium tablets (Kissei PHARMACEUTICAL CO., LTD. MATSUMOTO PLANT) as the reference preparation, the pharmacokinetic parameters Cmax, AUC0-t, and AUC0-∞ of the two preparations were compared, and the bioequivalence of the two preparations in humans was evaluated.

Start Date17 Feb 2022

Sponsor / Collaborator

Beijing Sihuan Kebao Pharmaceutical Co., Ltd.

100 Clinical Results associated with Mitiglinide Calcium Hydrate

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100 Translational Medicine associated with Mitiglinide Calcium Hydrate

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100 Patents (Medical) associated with Mitiglinide Calcium Hydrate

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297

Literatures (Medical) associated with Mitiglinide Calcium Hydrate

01 Jan 2025·Journal of Chromatography B

Non-targeted screening of illegal added hypoglycemic drugs and their derivatives in functional foods using characteristic fragment ions scanning based on liquid chromatography-high-resolution mass spectrometry

Article

Author: Liu, Yajie ; Feng, Xuesong ; Wang, Xiujuan ; Du, Rongzhu ; Zhang, Feng ; Feng, Feng

Functional foods that are illegally adulterated with chemical hypoglycemic drugs or their derivatives pose serious risks to human health. However, the detection of these compounds is a challenge due to the unknown nature of their structures, particularly as many of these compounds are newly synthesized and lack standardized references. In this study, we developed a non-targeted screening strategy for detecting illegally added hypoglycemic drugs and their derivatives in oral solution and hard capsule functional foods. This strategy utilizes a self-established characteristic fragment ions mass spectrum database based on ultrahigh-performance liquid chromatography-quadrupole/orbitrap high-resolution mass spectrometry. Nine characteristic fragment ions were identified by analyzing the mass spectrometric fragmentation patterns of hypoglycemic drugs. Meanwhile, the precursor and fragment ions of 38 known hypoglycemic drugs were collected and incorporated into the mass database. The detection limits of hypoglycemic drugs in oral solution and hard capsule samples were 0.01-10 μg/L and 0.01-50 μg/kg, respectively. Applying the non-targeted method to 20 batches of suspicious samples, we found that 3 batches of samples contained illegal added drugs. Furthermore, we identified a previously unrecorded hypoglycemic drug not present in the mass database. These results indicate that the developed strategy is a powerful tool for the rapid and highly sensitive identification of both known and unknown hypoglycemic drugs, as well as their derivatives in functional foods.

01 Apr 2024·Journal 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

Author: Tanaka, Yoshiya ; Uemura, Fumi ; Tateyama, Rina ; Hori, Yuri ; Okada, Yosuke ; Tomoyose, Yukiko ; Tokutsu, Akemi ; Tanaka, Kenichi ; Hashimoto, Ryoma ; Umezu, Saeko ; Saito, Momo ; Sonoda, Satomi ; Kurozumi, Akira

ABSTRACTIntroductionThe 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 MethodsIt 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.ResultsThe 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.ConclusionsIn 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.

01 Jan 2024·Saudi Pharmaceutical Journal

Preparation, in vitro and in vivo evaluation of a novel mitiglinide microemulsions

Article

Author: Wang, Miaomiao ; Yang, Wenzhi ; Li, Hanghang

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 (C_max, 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 Deals associated with Mitiglinide Calcium Hydrate

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External Link

KEGG	Wiki	ATC	Drug Bank
D01854	Mitiglinide Calcium Hydrate	A10BX08	DB01252

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Diabetes Mellitus, Type 2	Japan	Kissei Pharmaceutical Co., Ltd.	29 Jan 2004

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Endocrine System Diseases	Phase 2	China	Shanxi BaoTai Pharmaceutical Co. Ltd.	14 Nov 2012
Diabetes Mellitus, Noninsulin-Dependent, 2	Phase 2	-	Kissei Pharmaceutical Co., Ltd.	01 Aug 2006
Diabetes Mellitus, Type 2	Phase 2	Singapore	Eisai Co., Ltd.	-
Diabetes Mellitus, Type 2	Phase 2	Singapore	Eisai Co., Ltd.	-
Diabetes Mellitus, Type 2	Phase 2	Indonesia	Eisai Co., Ltd.	-
Diabetes Mellitus, Type 2	Phase 2	Malaysia	Eisai Co., Ltd.	-
Diabetes Mellitus, Type 2	Phase 2	Malaysia	Eisai Co., Ltd.	-
Diabetes Mellitus, Type 2	Phase 2	Indonesia	Eisai Co., Ltd.	-

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02154347 (CTgov)	Phase 4	Diabetes Mellitus, Type 2	178	Insulin+KAD-1229 (Placebo/KAD-1229)	arkyhcljbs(bypywzknhb) = ihmkpnwlcf ppdbwlftlv (rbmsnedqxh, jhujbcnjre - iwtboyxprr)	-	06 Sep 2019
				Insulin+KAD-1229 (KAD-1229/KAD-1229)	arkyhcljbs(bypywzknhb) = qsydxwhndp ppdbwlftlv (rbmsnedqxh, epegvrtvuu - wyfnkizzha)
NCT00663884 (GLORIA, Pubmed \| Endocr J) Manual	Phase 3	Diabetes Mellitus, Type 2	156	insulin glargine+mitiglinide	(dljnsdewrm) = hcforlwvdy xghhcdkzza (ljcfvxyxjd )	Non-inferior	01 Jan 2015
				insulin glargine+voglibose	(dljnsdewrm) = ybemqlfznl xghhcdkzza (ljcfvxyxjd )
NCT01456130 (CTgov)	Phase 3	Diabetes Mellitus, Type 2	67	Nateglinide+Alogliptin+Mitiglinide calcium hydrate	(mfkfompuaf) = kgltigmqyq kxggxffurj (hvwvobfgud, jowachufxt - lmdprkcaox) View more	-	21 Apr 2014
NCT01422590 (Pubmed \| Adv Ther)	Phase 1	Diabetes Mellitus, Type 2	26	Mitiglinide alone	(uihnbsktcn) = eqvqrfstmc ihssbzkzfi (xbisoqdpil )	Positive	01 Nov 2013
				Sitagliptin alone	(uihnbsktcn) = ckiqklgqbp ihssbzkzfi (xbisoqdpil )