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

Takeda Pharmaceutical Co., Ltd.

Hangzhou Zhongmeihuadong Pharmaceutical Co., Ltd.

CHEPLAPHARM Arzneimittel GmbH

+ [1]

Inactive Organization

Takeda Pharma A/S

Drug Highest PhaseApproved

First Approval Date

US (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

CTR20244521

/ Active, not recruitingNot 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

/ Active, not recruitingNot 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.

CTR20244046

/ CompletedNot Applicable

吡格列酮二甲双胍片人体生物等效性研究

[Translation] Study on the bioequivalence of pioglitazone and metformin tablets in healthy volunteers

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，测定上海青平药业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]

Taking 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-metformin tablets produced by Shanghai Qingping 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 Tube 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 Date31 Oct 2024

Sponsor / Collaborator

Shanghai Qingping 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 Mar 2022·Heliyon

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

Article

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

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

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

BACKGROUND:

Patients 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.

METHODS:

Thirty-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.

RESULTS:

HbA1c 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".

CONCLUSION:

HbA1c 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

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Infectious Diseases	US	Takeda Pharmaceuticals U.S.A., Inc.	12 May 2009
Weight Loss	US	Takeda Pharmaceuticals U.S.A., Inc.	12 May 2009
Diabetes Mellitus, Type 2	US	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
Dyslipidemias	Phase 3	DE	Takeda Pharmaceutical Co., Ltd.	01 Apr 2007
Metabolic Syndrome	Phase 3	-	Takeda Pharmaceutical Co., Ltd.	01 Jan 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)	roklxjebyi(yzkyewujga) = esfgnkxuwe kipjtzppmp (rxdrvsdyme, zlqcrdthdt - tpxcvvswzu) View more	-	10 Jun 2014
				Placebo (Placebo)	roklxjebyi(yzkyewujga) = bbswadwjua kipjtzppmp (rxdrvsdyme, uzhbcdmayx - dmivzknmir) View more
NCT00770653 (PIOfix, CTgov)	Phase 3	Diabetes Mellitus, Type 2 \| Dyslipidemias	305	Metformin (Pioglitazone 15 mg and Metformin 850 mg BID)	xojkxhfjqg(eucubxpdal) = qowtdvfldw flckhvjcbg (woikxxkutv, lrjkywuhoe - kpkaxeizwt) View more	-	06 Oct 2010
				Metformin+Glimepiride (Glimepiride 2 mg and Metformin 850 mg BID)	xojkxhfjqg(eucubxpdal) = hfghrebdls flckhvjcbg (woikxxkutv, jwocqfnhih - qgyzwsvfwg) View more

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

Chat with Hiro

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis