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

DyslipidemiasInfectious DiseasesMetabolic Syndrome+ [1]

Originator Organization

Takeda Pharmaceutical Co., Ltd.

Active Organization

Hangzhou Zhongmeihuadong Pharmaceutical Co., Ltd.

CHEPLAPHARM Arzneimittel GmbH

Takeda Pharmaceutical Co., Ltd.

+ [1]

Inactive Organization

Takeda Pharma A/S

License Organization-

Drug Highest PhaseApproved

First Approval Date

United States (29 Aug 2005),

Diabetes Mellitus, Type 2

Regulation-

Structure/Sequence

Molecular FormulaC23H33Cl2N7O3S

InChIKeyQQPUCHJKWMHONF-UHFFFAOYSA-N

CAS Registry737811-27-7

Clinical Trials associated with Metformin Hydrochloride/Pioglitazone Hydrochloride

CTR20250941

/ RecruitingNot Applicable

吡格列酮二甲双胍片在中国成年健康受试者中的一项随机、开放、空腹和餐后单次给药、两制剂、两序列、两周期交叉的生物等效性研究

[Translation] A randomized, open-label, single-dose, fasting and fed, two-formulation, two-sequence, two-period crossover bioequivalence study of pioglitazone-metformin tablets in healthy Chinese adult subjects

主要研究目的：考察空腹/餐后单次口服受试制剂吡格列酮二甲双胍片【规格：每片含盐酸吡格列酮15 mg（以吡格列酮计）和盐酸二甲双胍500 mg，河南大新药业有限公司生产】与参比制剂吡格列酮二甲双胍片【（商品名：メタクト®配合錠LD，规格：每片含盐酸吡格列酮15 mg（以吡格列酮计）和盐酸二甲双胍500 mg，武田テバ薬品株式会社持证生产）】，在中国成年健康人体的相对生物利用度，分析两种制剂的药代动力学参数，评价两制剂的生物等效性。次要研究目的：评价空腹/餐后单次口服受试制剂和参比制剂在中国成年健康受试者中的安全性。

[Translation]

Main research objectives: The relative bioavailability of the test preparation pioglitazone-metformin tablets [Specification: each tablet contains 15 mg pioglitazone hydrochloride (calculated as pioglitazone) and 500 mg metformin hydrochloride, produced by Henan Daxin Pharmaceutical Co., Ltd.] and the reference preparation pioglitazone-metformin tablets [(Trade name: メタクト® combined tablets LD, specification: each tablet contains 15 mg pioglitazone hydrochloride (calculated as pioglitazone) and 500 mg metformin hydrochloride, produced with a license by Takeda Teba Pharmaceutical Co., Ltd.)] after a single oral administration on an empty stomach or after a meal in healthy Chinese adults was investigated. The pharmacokinetic parameters of the two preparations were analyzed and the bioequivalence of the two preparations was evaluated. Secondary study objectives: To evaluate the safety of single oral administration of the test formulation and the reference formulation on an empty stomach or after a meal in healthy adult Chinese subjects.

Start Date07 Apr 2025

Sponsor / Collaborator

Henan Daxin Pharmaceutical Co Ltd.

CTR20244521

/ CompletedNot Applicable

吡格列酮二甲双胍片在健康受试者中空腹/餐后、单剂量口服、随机、开放、两制剂、两周期生物等效性研究

[Translation] A fasting/fed, single-dose oral, randomized, open-label, two-formulation, two-period bioequivalence study of pioglitazone and metformin tablets in healthy subjects

主要目的：通过空腹/餐后试验研究，考察中国健康受试者在空腹/餐后条件下单剂量口服浙江众延医药科技有限公司研制和提供的吡格列酮二甲双胍片（规格：15mg/500mg/片）与武田テバ薬品株式会社生产的吡格列酮二甲双胍片（规格：15mg/500mg/片）的体内药代动力学特征，评价两制剂的生物等效性。次要目的：评价单剂量口服吡格列酮二甲双胍片（规格：15mg/500mg/片）受试制剂及参比制剂在中国健康受试者中的安全性。

[Translation]

Primary objective: To investigate the in vivo pharmacokinetic characteristics of pioglitazone metformin tablets (specifications: 15mg/500mg/tablet) developed and provided by Zhejiang Zhongyan Pharmaceutical Technology Co., Ltd. and pioglitazone metformin tablets (specifications: 15mg/500mg/tablet) produced by Takeda Teba Pharmaceutical Co., Ltd. in Chinese healthy subjects after single oral administration under fasting/postprandial conditions, and to evaluate the bioequivalence of the two preparations. Secondary objective: To evaluate the safety of the test preparation and reference preparation of single oral pioglitazone metformin tablets (specifications: 15mg/500mg/tablet) in Chinese healthy subjects.

Start Date31 Dec 2024

Sponsor / Collaborator

Zhejiang Zhongyan Pharmaceutical Technology Co., Ltd

CTR20244295

/ CompletedNot Applicable

吡格列酮二甲双胍片在健康受试者中单剂量口服、随机、开放、两制剂、两周期生物等效性研究

[Translation] A single-dose oral, randomized, open-label, two-formulation, two-period bioequivalence study of pioglitazone and metformin tablets in healthy subjects

主要目的：通过空腹/餐后试验研究，考察中国健康受试者在空腹/餐后条件下单剂量口服石家庄市华新药业有限责任公司研制和提供的吡格列酮二甲双胍片（规格：15mg/500mg/片）与武田テバ薬品株式会社生产的吡格列酮二甲双胍片（规格：15mg/500mg/片）的体内药代动力学特征，评价两制剂的生物等效性。次要目的：评价单剂量口服吡格列酮二甲双胍片（规格：15mg/500mg/片）受试制剂及参比制剂在中国健康受试者中的安全性。

[Translation]

Main purpose: Through a fasting/postprandial test study, the in vivo pharmacokinetic characteristics of a single oral dose of pioglitazone metformin tablets (specifications: 15mg/500mg/tablet) developed and provided by Shijiazhuang Huaxin Pharmaceutical Co., Ltd. and pioglitazone metformin tablets (specifications: 15mg/500mg/tablet) produced by Takeda Teba Pharmaceutical Co., Ltd. were investigated in healthy Chinese subjects under fasting/postprandial conditions, and the bioequivalence of the two preparations was evaluated. Secondary purpose: Evaluate the safety of a single oral dose of pioglitazone metformin tablets (specifications: 15mg/500mg/tablet) and the reference preparation in healthy Chinese subjects.

Start Date13 Dec 2024

Sponsor / Collaborator

Shijiazhuang Huaxin Pharmaceutical 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 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.

01 Dec 2016·Die PharmazieQ4 · MEDICINE

A guide for using experimental design in chromatographic method development: applied to the analysis of selected anti-diabetic pharmaceutical combinations.

Q4 · MEDICINE

Article

Author: Ayoub, B. M. ; Abdel-Aziz, O.

A guide experimental design in chromatographic method development was described and applied successfully to the analysis of different recently approved anti-diabetic pharmaceutical combinations. Enhancement of UHPLC analysis of alogliptin benzoate either with pioglitazone hydrochloride or with metformin hydrochloride was achieved. The optimal chromatographic conditions were not attained by trial and error that requires a large number of experiments. Alternatively, a computer program was used as a systematic optimization strategy for the design of the experiment which accurately predicts the combined effect of different factors simultaneously. Resolution between peaks was studied by the proposed fractional factorial design approach performed by the Minitab® Program using screening and optimization steps. Application of the central composite design was implemented. A Pareto chart was used to exclude the insignificant variables. Linearity ranges were found to be 0.5-40 μg ml-1, 1-20 μg ml-1 and 1-32 μg ml-1 for alogliptin benzoate, pioglitazone hydrochloride and metformin hydrochloride, respectively. The proposed method is applicable for the analysis of six pharmaceutical dosage forms namely, Nesina®, Actos®, Glucophage®, Oseni®, Kazano® and Actoplus MET® tablets.

01 Jul 2011·Regulatory Toxicology and PharmacologyQ4 · MEDICINE

Evaluation of carcinogenicity studies of medicinal products for human use authorised via the European centralised procedure (1995–2009)

Q4 · MEDICINE

Article

Author: Anita Friedrich ; Klaus Olejniczak

Carcinogenicity data of medicinal products for human use that have been authorised via the European centralised procedure (CP) between 1995 and 2009 were evaluated. Carcinogenicity data, either from long-term rodent carcinogenicity studies, transgenic mouse studies or repeat-dose toxicity studies were available for 144 active substances contained in 159 medicinal products. Out of these compounds, 94 (65%) were positive in at least one long-term carcinogenicity study or in repeat-dose toxicity studies. Fifty compounds (35%) showed no evidence of a carcinogenic potential. Out of the 94 compounds with positive findings in either carcinogenicity or repeat-dose toxicity studies, 33 were positive in both mice and rats, 40 were positive in rats only, and 21 were positive exclusively in mice. Long-term carcinogenicity studies in two rodent species were available for 116 compounds. Data from one long-term carcinogenicity study in rats and a transgenic mouse model were available for eight compounds. For 13 compounds, carcinogenicity data were generated in only one rodent species. One compound was exclusively tested in a transgenic mouse model. Six compounds were tumourigenic in repeat-dose toxicity studies in rats. The majority of tumour findings observed in rodent carcinogenicity studies were considered not to be relevant for humans, either due to a rodent-specific mechanism of carcinogenicity, a high safety margin between exposures at the NOAEL (No Observed Adverse Effect Level) in rodents and recommended therapeutic doses in humans, or based on historical control data, a small effect size and lack of dose-response relationship and tumours typically observed in rodent strains used, or were considered not to be relevant for humans based on literature and clinical data or likely differences in metabolism/local concentrations between rodents and humans. Due to the high number of rodent tumour findings with unlikely relevance for humans, the value of the currently used testing strategy for carcinogenicity appears questionable. A revision of the carcinogenicity testing paradigm is warranted.

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

Approved

10 top approved records.

to view more data

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

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Diabetes Mellitus, Type 2	Discovery	Liechtenstein	Takeda Pharma A/S	11 Dec 2007
Diabetes Mellitus, Type 2	Discovery	Norway	Takeda Pharma A/S	11 Dec 2007
Diabetes Mellitus, Type 2	Discovery	Iceland	Takeda Pharma A/S	11 Dec 2007
Diabetes Mellitus, Type 2	Discovery	European Union	Takeda Pharma A/S	11 Dec 2007

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02099838 (CTgov)	Phase 4	Diabetes Mellitus, Type 2	98	Metformin (Pioglitazone and Metformin)	dtmoowyoqj(xyszdmaajq) = xiebmqolzx wtjponinnf (cdquenhqqv, bddehabhtq - uyfojetysw) View more	-	10 Jun 2014
				Placebo (Placebo)	dtmoowyoqj(xyszdmaajq) = zcbugxwdom wtjponinnf (cdquenhqqv, tajmkosavm - dhlzymnylf) View more
NCT00770653 (PIOfix, CTgov)	Phase 3	Diabetes Mellitus, Type 2 \| Dyslipidemias	305	Metformin (Pioglitazone 15 mg and Metformin 850 mg BID)	abkhjfgcwh(cqvpouvrmw) = hmuyqtyygc ixeisyfgcx (ehzhqwhxhs, msqbygkwdl - ysqyteeqdc) View more	-	06 Oct 2010
				Metformin+Glimepiride (Glimepiride 2 mg and Metformin 850 mg BID)	abkhjfgcwh(cqvpouvrmw) = fgwnxenhxz ixeisyfgcx (ehzhqwhxhs, rglnqqihur - pkdeqesedq) View more

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