PPARγ agonists(Peroxisome proliferator-activated receptor γ agonists), PRKAB1 activators(Protein kinase AMP-activated non-catalytic subunit beta 1 activators)

Therapeutic Areas

Endocrinology and Metabolic Disease

Active Indication

Diabetes Mellitus, Type 2

Inactive Indication

Infectious DiseasesWeight Loss

Originator Organization

Takeda Pharmaceutical Co., Ltd.

Active Organization

Takeda Pharmaceutical Co., Ltd.

CHEPLAPHARM Arzneimittel GmbH

Hangzhou Zhongmeihuadong Pharmaceutical Co., Ltd.

+ [1]

Inactive Organization

Takeda Pharma A/S

Drug Highest PhaseApproved

First Approval Date

US (29 Aug 2005),

Diabetes Mellitus, Type 2

Regulation-

Structure

Molecular FormulaC23H33Cl2N7O3S

InChIKeyQQPUCHJKWMHONF-UHFFFAOYSA-N

CAS Registry737811-27-7

Clinical Trials associated with Metformin Hydrochloride/Pioglitazone Hydrochloride

CTR20242466 / CompletedNot Applicable

一项在中国健康受试者中评估吡格列酮二甲双胍片（15 mg/500 mg）的空腹及餐后人体生物等效性研究

[Translation] A fasting and fed bioequivalence study of pioglitazone-metformin tablets (15 mg/500 mg) in healthy Chinese subjects

主要试验目的：研究空腹和餐后状态下单次口服受试制剂吡格列酮二甲双胍片（规格：15mg/500 mg ；浙江华海药业股份有限公司生产）与参比制剂吡格列酮二甲双胍片（メタクト配合錠LD；规格：15 mg/500 mg；武田テバ薬品株式会社生产）在健康受试者体内的药代动力学特征，评价空腹和餐后状态口服两种制剂的生物等效性。次要试验目的：研究受试制剂吡格列酮二甲双胍片（规格：15 mg/500 mg）和参比制剂吡格列酮二甲双胍片（メタクト®配合錠LD）（规格：15 mg/500 mg）在健康受试者中的安全性。

[Translation]

Main test purpose: Study the single oral administration of the test preparation pioglitazone metformin tablets (specification: 15 mg/500 mg; produced by Zhejiang Huahai Pharmaceutical Co., Ltd.) and the reference preparation pioglitazone metformin tablets (メタクト LD; specification: 15 mg) in the fasting and postprandial state /500 mg; manufactured by Takeda Tubi Co., Ltd.) in healthy subjects to evaluate the bioequivalence of the two oral preparations in the fasting and postprandial states. Secondary test purpose: The safety of the test preparation Pioglitazone Metformin Tablets (specification: 15 mg/500 mg) and the reference preparation Pioglitazone Metformin Tablets (Micromix® Tablets LD) (Specification: 15 mg/500 mg) was studied in healthy subjects.

Start Date13 Aug 2024

Sponsor / Collaborator

Zhejiang Huahai Pharmaceutical Co., Ltd.

CTR20242523 / CompletedNot Applicable

吡格列酮二甲双胍片[每片含盐酸吡格列酮15mg（以吡格列酮计）和盐酸二甲双胍500mg]在中国健康受试者中空腹和餐后给药条件下随机、开放、单次给药、两周期、双交叉生物等效性试验

[Translation] A randomized, open-label, single-dose, two-period, double-crossover bioequivalence study of pioglitazone-metformin tablets [each tablet contains 15 mg pioglitazone hydrochloride (calculated as pioglitazone) and 500 mg metformin hydrochloride] in Chinese healthy subjects under fasting and fed conditions

以中国健康受试者为试验对象，采用自身交叉对照的试验设计，测定海南皇隆制药股份有限公司生产的吡格列酮二甲双胍片给药后血浆中的二甲双胍和吡格列酮在健康受试者体内的血药浓度经时过程，估算相应的药代动力学参数，并以武田テバ薬品株式会社持证生产的吡格列酮二甲双胍片【商品名：メタクト®配合錠LD，规格：15mg/500mg】为参比，评价制剂间的生物等效性，并观察吡格列酮二甲双胍片在中国健康受试者中的安全性。

[Translation]

Using Chinese healthy subjects as test subjects, a self-cross-control experimental design was adopted to determine the plasma concentrations of metformin and pioglitazone in healthy subjects after administration of pioglitazone and metformin tablets produced by Hainan Huanglong Pharmaceutical Co., Ltd. Over time, the corresponding pharmacokinetic parameters were estimated, and the pioglitazone and metformin tablets [trade name: Pioglitazone® compound tablets LD, specification: 15mg/500mg] produced by Takeda Tubo Co., Ltd. with a license were used as a reference to evaluate the differences between preparations. The bioequivalence of pioglitazone and metformin tablets was observed in Chinese healthy subjects.

Start Date28 Jul 2024

Sponsor / Collaborator

Hainan Hualon Pharmaceutical Co., Ltd.

CTR20241580 / CompletedNot Applicable

一项随机、开放、单剂量、两周期、双交叉、空腹及餐后给药临床研究，评价吡格列酮二甲双胍片与メタクト®配合錠LD在中国健康成年受试者中的生物等效性

[Translation] A randomized, open-label, single-dose, two-cycle, double-crossover, fasting and postprandial clinical study to evaluate the bioequivalence of pioglitazone-metformin tablets and Miguro® combined tablets LD in Chinese healthy adult subjects

主要目的：以宁波美舒医药科技有限公司委托宁波美诺华天康药业有限公司生产的吡格列酮二甲双胍片为受试制剂（规格：15mg/500mg），按生物等效性试验的有关规定，与武田テバ薬品株式会社持有的吡格列酮二甲双胍片（商品名：メタクト®配合錠LD，规格：15mg/500mg）为参比制剂，进行生物等效性试验，比较两种制剂在空腹和餐后条件下单次给药的生物等效性。次要目的：评估单剂口服受试制剂（吡格列酮二甲双胍片，T）和参比制剂（メタクト®配合錠LD，R）在中国健康成年受试者中的安全性。

[Translation]

main purpose: The pioglitazone and metformin tablets produced by Ningbo Meihua Tiankang Pharmaceutical Co., Ltd. entrusted by Ningbo Meisu Pharmaceutical Technology Co., Ltd. were used as the test preparation (specification: 15mg/500mg). According to the relevant regulations of bioequivalence testing, it was compared with Takeda Tuopin Co., Ltd. The company's pioglitazone and metformin tablets (trade name: Mikuto® Formulated Tablets LD, specifications: 15mg/500mg) are used as reference preparations. Bioequivalence tests are conducted to compare the two preparations in single doses under fasting and postprandial conditions. of bioequivalence. Secondary purpose: To evaluate the safety of a single oral dose of the test preparation (Pioglitazone and Metformin Tablets, T) and the reference preparation (Pioglitazone® Tablets LD, R) in healthy Chinese adult subjects.

Start Date04 Jun 2024

Sponsor / Collaborator

Ningbo Meishu Pharmaceutical Technology Co., Ltd

100 Clinical Results associated with Metformin Hydrochloride/Pioglitazone Hydrochloride

100 Translational Medicine associated with Metformin Hydrochloride/Pioglitazone Hydrochloride

100 Patents (Medical) associated with Metformin Hydrochloride/Pioglitazone Hydrochloride

Literatures (Medical) associated with Metformin Hydrochloride/Pioglitazone Hydrochloride

01 Mar 2022·Heliyon

Enhanced circulation longevity and pharmacodynamics of metformin from surface-modified nanostructured lipid carriers based on solidified reverse micellar solutions

Article

Author: Nnamani, Daniel Okwudili ; Isaac, God'spower Tochukwu ; Momoh, Mumuni Audu ; Attama, Anthony Amaechi ; Kenechukwu, Franklin Chimaobi

Metformin hydrochloride (MTH) has been associated with poor/incomplete absorption (50-60%), low bioavailability, short half-life (0.4-0.5 h), high dosage and dose-related side effects. To overcome these barriers and improve oral bioavailability and efficacy of MTH, surface-modified nanostructured lipid carriers (NLCs) were developed. Lipid matrices composed of rational blends of beeswax and Phospholipon® 90H (as solid lipids) and Capryol-PGE 860 (as liquid lipid) were prepared by fusion, and the resultant lipid matrices were PEGylated to give 10, 20 and 40% PEGylated lipid matrices. MTH-loaded non-PEGylated and PEGylated NLCs were prepared via high-shear hot homogenization and characterized regarding particle properties and physicochemical performance. The encapsulation efficiencies (EE%) and loading capacities (LC) of the MTH-loaded NLCs were determined while the in vitro drug release was evaluated in phosphate buffered saline (PBS, pH 7.4). Antidiabetic and pharmacokinetics properties of the NLCs were ascertained in an alloxan-induced diabetic rats model after oral administration. The MTH-loaded NLCs were nanomeric (particle size: 184.8-882.50 nm) with low polydispersity index (0.368-0.687) and zeta potential (26.5-34.2 mV), irregular shape, amorphous nature with reduced crystallinity. The EE% and LC were >90 % and 16%, respectively. The formulations showed >65 % release over 12 h in a greater sustained manner than marketed MTH formulation (Glucophage®) as well as enhanced pharmacokinetics properties and sustained blood glucose lowering effect, even at reduced doses with PEGylated NLCs than Glucophage®. Thus, PEGylated NLC is a promising approach for improved delivery and oral bioavailability of MTH thus encouraging further development of the formulation.

28 Apr 2020·Mediators of InflammationQ3 · MEDICINE

Pioglitazone Metformin Complex Improves Polycystic Ovary Syndrome Comorbid Psychological Distress via Inhibiting NLRP3 Inflammasome Activation: A Prospective Clinical Study

Q3 · MEDICINE

ArticleOA

Author: Yu, Chao-qin ; Huo, Cui-lan ; Zhou, Hui ; Song, Jing-yun ; Shan, Jing ; Wang, Chao-qun ; Guo, Qing-jun ; Hu, Yan-yan ; Xu, Yi-feng ; Huang, Qin

Objective. This study aimed at investigating the therapeutic effect and mechanism of pioglitazone metformin complex preparation (PM) in polycystic ovary syndrome (PCOS) comorbid psychological distress. Methods. Seventy-five patients with PCOS comorbid psychological distress were randomly allocated into the PM, metformin, and placebo groups. The primary efficacy measure was the change from baseline to week 12 on the Symptom Checklist 90-R (SCL-90-R) scores. NLRP3 inflammasome, IL-1β, IL-6, TNF-α, and biochemical parameters were determined at baseline and at week 12. The participants were required to meet the criteria for PCOS (Rotterdam, NIH) and psychological distress (any factor scores of SCL−90−R>2). Results. The participants had significantly high scores on the SCL-90-R scales of anxiety and depression. PM significantly decreased anxiety and depression symptom severity (from 2.31±0.75 to 1.65±0.38, p<0.001, and from 2.08±0.74 to 1.61±0.46, p=0.010, at week 12, respectively). PM significantly decreased the expression of NRPL3 and caspase-1. Patients in the PM group experienced a significant reduction in IL-1β (from 98.42±14.38 to 71.76±13.66, p=0.02), IL-6 (from 87.51±8.74 to 71.98±15.87, p=0.02), and TNF-α (from 395.33±88.55 to 281.98±85.69, p=0.04). PM was superior to metformin in reducing total testosterone (2.24±0.74 versus 3.06±0.83, p=0.024, at week 12).Conclusions. This study is the first to reveal that PM alleviates psychological distress via inhibiting NLRP3 inflammasome and improves several markers, including total testosterone.

01 Jan 2017·Journal of Clinical Medicine Research

Effect of Switching From an Anti-Diabetic Loose Dose Combination to a Fixed Dose Combination Regimen at Equivalent Dosage for 6 Months on Glycemic Control in Japanese Patients With Type 2 Diabetes: A Pilot Study

Article

Author: Taguri, Masataka ; Kamiyama, Hiroshi ; Kamiko, Kazunari ; Terauchi, Yasuo ; Furuie, Tadashi ; Aoki, Kazutaka ; Nakajima, Shigeru ; Masumura, Makoto ; Nagakura, Mieko ; Oka, Masanao ; Akema, Noriko

BACKGROUNDPatients with type 2 diabetes mellitus often take multiple anti-diabetic drugs for a long period. Fixed dose combination (FDC) therapy is expected to improve drug adherence for patients with diabetes. The effect of switching from a loose dose combination (LDC) regimen to an FDC regimen at equivalent dosage on glycemic control has not been evaluated fully. Therefore, we investigated the effect of switching from LDC to FDC at equivalent dosage for 6 months on glycemic control in Japanese patients with type 2 diabetes.METHODSThirty-eight Japanese patients with type 2 diabetes who were taking anti-diabetic drugs including pioglitazone + metformin, pioglitazone + alogliptin, or pioglitazone + glimepiride were enrolled. These drugs were switched to an FDC of Metact^®, Liobel^® or Sonias^®, respectively, at equivalent dosage. Other anti-diabetic drugs and units of insulin were not changed during the study if possible. HbA1c and body weight were measured 0, 2, 4 and 6 months after switching from an LDC to FDC. We also conducted a questionnaire survey 2 months after the start of the FDC regimen.RESULTSHbA1c levels at 2, 4, and 6 months were not significantly changed compared with prior to switching from an LDC to FDC regimen. Moreover, 74.2% of patients considered decreasing the number of drugs to be "very good" or "good".CONCLUSIONHbA1c levels did not differ between patients receiving LDC and FDC therapy at equivalent dosage in this study.

News (Medical) associated with Metformin Hydrochloride/Pioglitazone Hydrochloride

12 Aug 2024

·www.echemi.com

The Race for China's Next Top Diabetes Drug: Winsunny Pharmaceutical and Yiheng Pharma Vie for Pioglitazone and Metformin Combination

On August 8, the official website of China Medical Science and Technology Achievements Transformation Center (CDE) released a news that Beijing Winsunny Pharmaceutical and Nanjing EASEHEAL Pharmaceutical two companies of pioglitazone metformin tablet generic drug listing application has been officially accepted. The news quickly garnered widespread attention as it heralded the arrival of a new player in a high-profile drug market competition. Pioglitazone metformin tablets are a drug widely used to improve blood sugar control in people with type 2 diabetes. In 2023, the drug's sales in the national hospital market have exceeded 1 billion yuan, a year-on-year increase of 14.09%, ranking 12th in the diabetes treatment drug market, according to data from Yaofongyun. At present, only two companies in the market, Jiangsu Deyuan Pharma and Hangzhou Huadong Medicine, have been approved for production and passed the consistency evaluation. Pioglitazone metformin tablets are a diabetes treatment made from a combination of two active ingredients: metformin and pioglitazone. It is primarily used to treat type 2 diabetes. Its dual action mechanism is embodied in the following two aspects: First, pioglitazone effectively promotes the conversion and utilization of glucose in muscle and adipose tissue by improving the body's sensitivity to insulin, thereby improving the body's ability to regulate blood sugar. Secondly, metformin further reduces blood sugar levels by inhibiting the production of glucose in the liver, thus achieving effective control of blood sugar. The drug is effective, can effectively control fasting blood glucose and postprandial blood glucose, improve the metabolic disorders of diabetes. It can also delay the development of type 2 diabetes and prevent and reduce the occurrence of complications. Pioglitazone metformin tablets have a good safety profile, do not cause common insulin treatment side effects such as hypoglycemia, and can reduce the risk of cardiovascular disease, cardiometabolic protection. In addition, the drug only needs to be taken once a day and is convenient to administer, helping to improve patient compliance. The application of Beijing Winsunny Pharmaceutical and Nanjing EASEHEAL Pharmaceutical was accepted, indicating that China will have a third pharmaceutical company qualified to produce this diabetes treatment drug. This will undoubtedly provide more options for patients and could increase competition among Chinese pharmaceutical companies. In recent years, Beijing Winsunny Pharmaceutical has been active in the application of new drugs, including 18 varieties including bromohexine hydrochloride oral solution, Lansoprazole enteric capsules, etc., are being declared. Nanjing EASEHEAL Pharmaceutical also recently has a number of generic drugs in the review stage, such as voriconazole dry suspension, Indapamide sustained-release tablets. With the addition of more players, the pioglitazone metformin tablet market is expected to become more diversified, offering more quality treatment options for patients with diabetes. This will undoubtedly drive continued innovation in the field and let us look forward to the future.

Drug Approval

100 Deals associated with Metformin Hydrochloride/Pioglitazone Hydrochloride

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	A10BD05	-

R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Diabetes Mellitus, Type 2	US	Takeda Pharmaceuticals U.S.A., Inc.	29 Aug 2005

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


EDICT (Pubmed \| Diabetes Obes Metab)	Not Applicable	Diabetes Mellitus Add-on	-	Metformin/pioglitazone/exenatide	(evelarwrsu) = ioevjqlkvr gcvtfvydzo (xgxzhklzbk )	Positive	01 Mar 2015
				Metformin/sulfonylurea/glargine insulin	(evelarwrsu) = wcnpqwmorb gcvtfvydzo (xgxzhklzbk ) View more
NCT02099838 (CTgov)	Phase 4	Diabetes Mellitus, Type 2	98	Metformin (Pioglitazone and Metformin)	qlqmcisohv(hqzszjrpvf) = bmfejhstxa csdkmhqgpb (njaulfnprz, hbrjnexrvv - nkkwcbrktw) View more	-	10 Jun 2014
				Placebo (Placebo)	qlqmcisohv(hqzszjrpvf) = xweecsdtmu csdkmhqgpb (njaulfnprz, pbwbdtufqe - idfjeqyrcv) View more
NCT00770653 (PIOfix, CTgov)	Phase 3	Diabetes Mellitus, Type 2 \| Dyslipidemias	305	Metformin (Pioglitazone 15 mg and Metformin 850 mg BID)	vnqcqbdwvb(nyfkflbdey) = tfgwqwxwux jwmftccyvr (pufjbnwwkk, rusfwwgfmp - ityfceunir) View more	-	06 Oct 2010
				Metformin (Glimepiride 2 mg and Metformin 850 mg BID)	vnqcqbdwvb(nyfkflbdey) = edivobupsg jwmftccyvr (pufjbnwwkk, tilorouenu - ebbkycxilv) View more

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