Delving into the Latest Updates on Glimepiride/Pioglitazone Hydrochloride with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Duetact, Pioglitazone/Glimepiride, Tandemact

+ [3]

Target

KATP channels x PPARγ x SUR

Mechanism

KATP channels blockers, PPARγ agonists(Peroxisome proliferator-activated receptor γ agonists), SUR modulators(Sulfonylurea receptor modulators)

Therapeutic Areas

Endocrinology and Metabolic Disease

Active Indication

Diabetes Mellitus, Type 2

Inactive Indication-

Originator Organization

Takeda Pharmaceutical Co., Ltd.

Active Organization

CHEPLAPHARM Arzneimittel GmbH

Takeda Pharmaceutical Co., Ltd.Takeda Pharmaceuticals U.S.A., Inc.

Inactive Organization-

Drug Highest PhaseApproved

First Approval Date

US (28 Jul 2006),

Diabetes Mellitus, Type 2

Regulation-

Login to view timeline

Structure

Molecular FormulaC43H55ClN6O8S2

InChIKeyRWJPQBWTYNIUEF-NURFIRCWSA-N

CAS Registry2509313-62-4

选择男性健康志愿者为受试者，观察单剂量口服江苏德源药业有限公司研制的盐酸吡格列酮格列美脲片（15mg/1mg）后吡格列酮和格列美脲的血药浓度经时过程，估算相应的药代动力学参数，并以格列美脲片（商品名：亚莫利）和盐酸吡格列酮片（商品名：艾可拓）为标准参比制剂，进行生物利用度和生物等效性评价，为新药临床研究提供依据。

[Translation]

Male healthy volunteers were selected as subjects. The time course of blood concentrations of pioglitazone and glimepiride after a single oral dose of pioglitazone hydrochloride glimepiride tablets (15mg/1mg) developed by Jiangsu Deyuan Pharmaceutical Co., Ltd. was observed, and the corresponding pharmacokinetic parameters were estimated. Glimepiride tablets (trade name: Amaril) and pioglitazone hydrochloride tablets (trade name: Actos) were used as standard reference preparations to evaluate bioavailability and bioequivalence, in order to provide a basis for clinical research of new drugs.

Start Date17 Sep 2014

Sponsor / Collaborator

Jiangsu Deyuan Pharmaceutical Co., Ltd.

CTR20150219 / CompletedPhase 1

吡格列酮格列美脲片人体生物利用度试验

[Translation] Bioavailability study of pioglitazone-glimepiride tablets in human body

健康受试者进行吡格列酮格列美脲片的人体生物利用度试验，考察吡格列酮格列美脲片与日本武田药品工业株式会社的盐酸吡格列酮片（艾可拓）和赛诺菲安万特（北京）制药有限公司生产的格列美脲片（亚莫利）的相对生物利用度，为制定吡格列酮格列美脲片II期临床试验方案提供试验依据，为临床用药的给药剂量提供依据。

[Translation]

A human bioavailability study of pioglitazone-glimepiride tablets was conducted on healthy subjects to investigate the relative bioavailability of pioglitazone-glimepiride tablets and pioglitazone hydrochloride tablets (Actos) produced by Takeda Pharmaceutical Company Limited of Japan and glimepiride tablets (Amaryl) produced by Sanofi-Aventis (Beijing) Pharmaceuticals Co., Ltd., to provide an experimental basis for the formulation of the Phase II clinical trial plan of pioglitazone-glimepiride tablets and to provide a basis for the dosage of clinical medication.

Start Date12 Aug 2013

Sponsor / Collaborator

Tianjin Institute of Pharmaceutical Research Co., Ltd.

[+1]

100 Clinical Results associated with Glimepiride/Pioglitazone Hydrochloride

Login to view more data

100 Translational Medicine associated with Glimepiride/Pioglitazone Hydrochloride

Login to view more data

100 Patents (Medical) associated with Glimepiride/Pioglitazone Hydrochloride

Login to view more data

3

Literatures (Medical) associated with Glimepiride/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.

29 Jun 2011·BMJ

European drug agency extends review of safety of pioglitazone

Author: Moynihan, R.

The European Medicines Agency will decide the fate of the type 2 diabetes treatment pioglitazone later in July, after the release of new data indicating that long term use is associated with a slightly raised risk of bladder cancer. New warnings have been issued in the United States, while French authorities have suspended use of drugs containing pioglitazone, which is sold under brand names including Actos, Glustin, Competact, Glubrava, and Tandemact. Marketed for more than a decade, pioglitazone had total sales last year of almost £3bn (€3.4bn; $4.8bn) and is an important earner for the Japanese company Takeda. A competitor drug, rosiglitazone (sold as Avandia), was withdrawn from the European market last year after evidence …

17 Mar 2007·BMJ

Fracture risk a class effect of thiazolidinediones in women

Author: Short, Robert

Treatment with thiazolidinediones (glitazones) for type 2 diabetes has been found to increase the risk of fractures in women. Pioglitazone has now joined rosiglitazone, as the subject of a US Food and Drug Administration alert for fracture risk. Takeda, the makers of pioglitazone (contained in Actos, Actosplusmet, and Duetact), and GlaxoSmithKline, the makers of rosiglitazone (contained in Avandia and Avandamet), have contacted US healthcare professionals setting out the evidence on fracture risk and recommending that they consider this risk when starting or treating women with type 2 diabetes with these agents. The statement on pioglitazone …

100 Deals associated with Glimepiride/Pioglitazone Hydrochloride

Login to view more data