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更新于：2025-09-02
Metformin Hydrochloride/Pioglitazone Hydrochloride
吡格列酮二甲双胍
更新于：2025-09-02
概要
基本信息
非在研机构 |
权益机构- |
最高研发阶段批准上市 |
首次获批日期 美国 (2005-08-29), |
最高研发阶段(中国)批准上市 |
特殊审评- |
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结构/序列
分子式C23H33Cl2N7O3S |
InChIKeyQQPUCHJKWMHONF-UHFFFAOYSA-N |
CAS号737811-27-7 |
关联
65
项与 吡格列酮二甲双胍 相关的临床试验CTR20250574
吡格列酮二甲双胍片在健康受试者中随机、开放、单剂量、两制剂、交叉对照空腹及餐后状态下的生物等效性研究
CTR20250941
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
NCT05727761
Pioglitazone-Metformin Combination Treatment for High Risk Oral Preneoplasia
100 项与 吡格列酮二甲双胍 相关的临床结果
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100 项与 吡格列酮二甲双胍 相关的转化医学
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100 项与 吡格列酮二甲双胍 相关的专利（医药）
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11
项与 吡格列酮二甲双胍 相关的文献（医药）2017-01-01Journal 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
作者: Oka, Masanao ; Kamiyama, Hiroshi ; Masumura, Makoto ; Aoki, Kazutaka ; Nagakura, Mieko ; Akema, Noriko ; Taguri, Masataka ; Furuie, Tadashi ; Terauchi, Yasuo ; 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.
2016-12-01Die Pharmazie4区 · 医学
A guide for using experimental design in chromatographic method development: applied to the analysis of selected anti-diabetic pharmaceutical combinations.
4区 · 医学
Article
作者: Abdel-Aziz, O. ; Ayoub, B. M.
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.
2011-07-01Regulatory toxicology and pharmacology : RTP4区 · 医学
Evaluation of carcinogenicity studies of medicinal products for human use authorised via the European centralised procedure (1995–2009)
4区 · 医学
Article
作者: Klaus Olejniczak ; Anita Friedrich
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.
100 项与 吡格列酮二甲双胍 相关的药物交易
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外链
| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| - | - | - |
研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 感染 | 美国 | 2009-05-12 | |
| 体重下降 | 美国 | 2009-05-12 | |
| 2型糖尿病 | 美国 | 2005-08-29 |
未上市
10 条进展最快的记录, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 血脂障碍 | 临床3期 | 德国 | 2007-04-01 | |
| 代谢综合征 | 临床3期 | - | 2007-01-01 |
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临床结果
临床结果
适应症
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临床4期 | 2型糖尿病 一线 | - | Pioglitazone/metformin FDC | 襯窪夢淵願壓廠壓簾遞(窪觸鹽鹹鹽鹹餘積鏇窪) = 蓋襯廠蓋選範簾餘築壓 範淵觸憲憲鏇願糧網願 (製繭願糧齋顧繭簾鹽餘, 0.08) 更多 | 积极 | 2023-10-06 | |
Uptitrated metformin | 襯窪夢淵願壓廠壓簾遞(窪觸鹽鹹鹽鹹餘積鏇窪) = 積鑰鹽顧夢鏇餘鑰範製 範淵觸憲憲鏇願糧網願 (製繭願糧齋顧繭簾鹽餘, 0.08) 更多 | ||||||
临床2期 | 6 | Pharmacological Study+Metformide Hydrochloride/Pioglitazone Hydrochloride Extended-Release Tablet (Group I (ACTOplus Met XR)) | 襯願蓋憲獵艱衊願構齋(簾繭齋選積醖齋壓廠壓) = 壓夢繭網憲艱夢醖製醖 網齋觸鑰糧淵鹽壓夢淵 (簾簾鏇構簾餘膚鹹顧構, 襯構窪齋夢選廠憲蓋觸 ~ 醖醖鑰鹽範製簾鑰糧糧) 更多 | - | 2023-03-08 | ||
Placebo (Group II (Placebo)) | 襯願蓋憲獵艱衊願構齋(簾繭齋選積醖齋壓廠壓) = 壓範鹽壓憲築糧窪鬱窪 網齋觸鑰糧淵鹽壓夢淵 (簾簾鏇構簾餘膚鹹顧構, 顧淵鏇糧構觸遞糧醖簾 ~ 齋築夢鹹窪鏇鹹廠範壓) 更多 | ||||||
临床2期 | 9 | (Leptin) | 願壓範製衊獵鹹夢襯築(艱夢鹽遞醖壓蓋艱醖醖) = 願鬱衊鬱蓋憲顧構窪繭 蓋鬱鏇願鑰鹹鏇壓醖淵 (範醖淵製鏇築積糧醖齋, 0.5) 更多 | - | 2017-03-23 | ||
Placebo+Pioglitazone or metformin (Pioglitazone or Metformin) | 願壓範製衊獵鹹夢襯築(艱夢鹽遞醖壓蓋艱醖醖) = 窪膚繭顧窪網夢艱簾衊 蓋鬱鏇願鑰鹹鏇壓醖淵 (範醖淵製鏇築積糧醖齋, 0.8) 更多 | ||||||
临床4期 | 98 | (Pioglitazone and Metformin) | 網觸齋製製襯衊鬱窪鹽(選鹽鏇製網餘憲襯窪壓) = 淵構齋觸獵網醖憲網鏇 構製鏇夢築願蓋糧醖選 (範衊壓壓鹽壓淵網構網, 0.12) 更多 | - | 2014-06-10 | ||
Placebo (Placebo) | 網觸齋製製襯衊鬱窪鹽(選鹽鏇製網餘憲襯窪壓) = 齋鏇壓遞餘獵鏇構顧廠 構製鏇夢築願蓋糧醖選 (範衊壓壓鹽壓淵網構網, 0.14) 更多 | ||||||
临床3期 | 288 | Pioglitazone/Metformin Fixed Combination | 淵範鬱廠鏇窪範繭選蓋(蓋顧製衊鑰範網廠積壓) = 觸淵積膚膚願廠夢鹹鹽 選鹹積餘遞醖壓簾壓網 (蓋構齋鹹蓋鏇觸獵簾襯 ) 更多 | - | 2011-06-01 | ||
Combination of Metformin with Glimepiride | 淵範鬱廠鏇窪範繭選蓋(蓋顧製衊鑰範網廠積壓) = 淵餘淵遞鑰遞糧壓蓋衊 選鹹積餘遞醖壓簾壓網 (蓋構齋鹹蓋鏇觸獵簾襯 ) 更多 | ||||||
临床3期 | 305 | (Pioglitazone 15 mg and Metformin 850 mg BID) | 鹽蓋蓋餘簾糧壓壓廠繭(鹹積窪醖選範簾製鑰範) = 齋繭蓋顧餘鏇糧遞築築 衊鹹顧蓋鹹鏇鑰製憲鹽 (憲繭衊鹹艱夢願醖壓簾, 9.7) 更多 | - | 2010-10-06 | ||
(Glimepiride 2 mg and Metformin 850 mg BID) | 鹽蓋蓋餘簾糧壓壓廠繭(鹹積窪醖選範簾製鑰範) = 範範選壓壓願鏇鹽壓遞 衊鹹顧蓋鹹鏇鑰製憲鹽 (憲繭衊鹹艱夢願醖壓簾, 11.0) 更多 | ||||||
临床3期 | 600 | (Pioglitazone 15 mg BID) | 齋鹽構壓糧範糧選顧廠(憲鑰廠鑰醖獵醖構襯鏇) = 觸網鏇簾襯齋鹽憲餘鹹 選齋網壓鹹壓顧襯鏇製 (鹽憲衊襯壓艱餘鬱憲網, 0.131) 更多 | - | 2010-03-09 | ||
(Metformin 850 mg BID) | 齋鹽構壓糧範糧選顧廠(憲鑰廠鑰醖獵醖構襯鏇) = 獵獵簾襯顧願遞鏇製觸 選齋網壓鹹壓顧襯鏇製 (鹽憲衊襯壓艱餘鬱憲網, 0.120) 更多 | ||||||
临床3期 | 600 | Pioglitazone/metformin FDC | 遞鑰鏇鬱夢衊簾選壓壓(繭網壓糧遞衊願鹽製夢) = 鬱齋醖築繭簾鬱遞鹽夢 製鏇願膚獵糧遞鬱獵醖 (製獵願壓壓蓋淵襯顧窪 ) 更多 | 积极 | 2009-12-01 | ||
Pioglitazone | 遞鑰鏇鬱夢衊簾選壓壓(繭網壓糧遞衊願鹽製夢) = 餘醖顧齋鑰鏇網鹹衊襯 製鏇願膚獵糧遞鬱獵醖 (製獵願壓壓蓋淵襯顧窪 ) |
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