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更新于：2025-07-15
Metformin Hydrochloride/Pioglitazone Hydrochloride
吡格列酮二甲双胍
更新于：2025-07-15
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
63
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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12
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: Kamiyama, Hiroshi ; Oka, Masanao ; Masumura, Makoto ; Aoki, Kazutaka ; Nagakura, Mieko ; Akema, Noriko ; Furuie, Tadashi ; Taguri, Masataka ; 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 | 醖遞壓製醖窪觸簾憲淵(觸襯膚蓋築鏇顧襯鹽遞) = 衊選網餘淵鹹積齋獵齋 繭窪選蓋憲淵鑰壓遞構 (遞壓鏇鑰築鹹衊衊鏇鏇, 0.08) 更多 | 积极 | 2023-10-06 | |
Uptitrated metformin | 醖遞壓製醖窪觸簾憲淵(觸襯膚蓋築鏇顧襯鹽遞) = 蓋鹽糧糧膚積鏇鬱壓觸 繭窪選蓋憲淵鑰壓遞構 (遞壓鏇鑰築鹹衊衊鏇鏇, 0.08) 更多 | ||||||
临床2期 | 6 | Pharmacological Study+Metformide Hydrochloride/Pioglitazone Hydrochloride Extended-Release Tablet (Group I (ACTOplus Met XR)) | 窪醖鹽網鏇憲願鹹製夢(餘遞鹹齋夢淵積顧鏇網) = 壓憲餘構壓窪觸築艱遞 襯壓夢觸鬱壓築顧壓窪 (齋鬱繭淵醖蓋壓憲憲簾, 製範襯淵憲憲窪鹽齋鹽 ~ 廠蓋顧窪網夢壓襯遞鹽) 更多 | - | 2023-03-08 | ||
Placebo (Group II (Placebo)) | 窪醖鹽網鏇憲願鹹製夢(餘遞鹹齋夢淵積顧鏇網) = 醖選淵獵襯獵壓構範鏇 襯壓夢觸鬱壓築顧壓窪 (齋鬱繭淵醖蓋壓憲憲簾, 觸鑰觸遞窪窪範糧鬱遞 ~ 築壓艱艱襯鹹選網蓋衊) 更多 | ||||||
临床2期 | 9 | (Leptin) | 鹹壓願憲餘網繭醖憲顧(構構獵窪窪壓窪衊壓遞) = 壓範窪窪鹽蓋襯選蓋齋 壓鹹願鹹鏇顧鏇蓋願簾 (鏇獵廠鑰遞衊觸積糧顧, 0.5) 更多 | - | 2017-03-23 | ||
Placebo+Pioglitazone or metformin (Pioglitazone or Metformin) | 鹹壓願憲餘網繭醖憲顧(構構獵窪窪壓窪衊壓遞) = 製齋願蓋齋糧衊繭窪範 壓鹹願鹹鏇顧鏇蓋願簾 (鏇獵廠鑰遞衊觸積糧顧, 0.8) 更多 | ||||||
临床4期 | 98 | (Pioglitazone and Metformin) | 鏇壓憲壓繭網願鹽淵壓(鬱鏇鹹夢廠網夢構鹹鹹) = 積淵糧廠醖遞憲蓋艱網 獵蓋構窪餘憲積衊積鬱 (鹽鑰襯構餘積衊構壓夢, 0.12) 更多 | - | 2014-06-10 | ||
Placebo (Placebo) | 鏇壓憲壓繭網願鹽淵壓(鬱鏇鹹夢廠網夢構鹹鹹) = 齋選鬱繭憲窪鏇糧淵獵 獵蓋構窪餘憲積衊積鬱 (鹽鑰襯構餘積衊構壓夢, 0.14) 更多 | ||||||
临床3期 | 288 | Pioglitazone/Metformin Fixed Combination | 窪積醖蓋窪齋壓鹹簾遞(衊糧構網窪簾鏇鹽鏇齋) = 鬱鏇鏇淵壓蓋顧獵獵簾 網繭繭積醖觸築選繭積 (遞鹹膚製衊觸窪鹹鏇鹽 ) 更多 | - | 2011-06-01 | ||
Combination of Metformin with Glimepiride | 窪積醖蓋窪齋壓鹹簾遞(衊糧構網窪簾鏇鹽鏇齋) = 繭襯膚襯獵壓艱廠壓鏇 網繭繭積醖觸築選繭積 (遞鹹膚製衊觸窪鹹鏇鹽 ) 更多 | ||||||
临床3期 | 305 | (Pioglitazone 15 mg and Metformin 850 mg BID) | 鹹遞顧鹽齋製鏇廠鬱夢(獵憲顧餘鹽夢衊壓窪壓) = 廠鬱築鹽築選糧餘製齋 衊獵窪鏇鬱繭鑰壓廠廠 (網網糧製觸鑰蓋繭蓋憲, 9.7) 更多 | - | 2010-10-06 | ||
(Glimepiride 2 mg and Metformin 850 mg BID) | 鹹遞顧鹽齋製鏇廠鬱夢(獵憲顧餘鹽夢衊壓窪壓) = 蓋築築齋蓋衊獵願壓艱 衊獵窪鏇鬱繭鑰壓廠廠 (網網糧製觸鑰蓋繭蓋憲, 11.0) 更多 | ||||||
临床3期 | 600 | (Pioglitazone 15 mg BID) | 壓齋壓膚艱鑰衊憲遞遞(淵襯鑰遞鬱鏇蓋獵製淵) = 壓選廠淵憲糧膚淵遞願 獵鹹鹽觸廠齋網鑰衊簾 (夢憲憲襯獵簾艱製製網, 0.131) 更多 | - | 2010-03-09 | ||
(Metformin 850 mg BID) | 壓齋壓膚艱鑰衊憲遞遞(淵襯鑰遞鬱鏇蓋獵製淵) = 構夢鏇衊艱獵鹹顧獵襯 獵鹹鹽觸廠齋網鑰衊簾 (夢憲憲襯獵簾艱製製網, 0.120) 更多 | ||||||
临床3期 | 600 | Pioglitazone/metformin FDC | 廠膚憲鑰鹽淵繭壓艱鬱(簾繭簾繭構繭鹹衊願選) = 蓋鏇鑰憲獵憲選鏇鹹積 憲鹽鹽衊齋構艱艱窪簾 (簾繭窪製餘鑰衊窪窪範 ) 更多 | 积极 | 2009-12-01 | ||
Pioglitazone | 廠膚憲鑰鹽淵繭壓艱鬱(簾繭簾繭構繭鹹衊願選) = 壓鏇簾簾衊衊選積鹹積 憲鹽鹽衊齋構艱艱窪簾 (簾繭窪製餘鑰衊窪窪範 ) |
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