Efficacy and safety of luseogliflozin added to various oral antidiabetic drugs in Japanese patients with type 2 diabetes mellitus
Introduction Two studies were carried out to investigate the efficacy and safety of luseogliflozin added to existing oral antidiabetic drugs (OADs) in Japanese type 2 diabetic patients inadequately controlled with OAD monotherapy. Materials and Methods In the trial involving add‐on to sulfonylureas...
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| Veröffentlicht in: | Journal of diabetes investigation 2015-07, Vol.6 (4), p.443-453 |
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| description | Introduction
Two studies were carried out to investigate the efficacy and safety of luseogliflozin added to existing oral antidiabetic drugs (OADs) in Japanese type 2 diabetic patients inadequately controlled with OAD monotherapy.
Materials and Methods
In the trial involving add‐on to sulfonylureas (study 03‐1), patients were randomly assigned to receive luseogliflozin 2.5 mg or a placebo for a 24‐week double‐blind period, followed by a 28‐week open‐label period. In the open‐label trial involving add‐on to other OADs; that is, biguanides, dipeptidyl peptidase‐4 inhibitors, thiazolidinediones, glinides and α‐glucosidase inhibitors (study 03‐2), patients received luseogliflozin for 52 weeks.
Results
In study 03‐1, luseogliflozin significantly decreased glycated hemoglobin at the end of the 24‐week double‐blind period compared with the placebo (–0.88%, P |
| doi_str_mv | 10.1111/jdi.12316 |
| format | Article |
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Two studies were carried out to investigate the efficacy and safety of luseogliflozin added to existing oral antidiabetic drugs (OADs) in Japanese type 2 diabetic patients inadequately controlled with OAD monotherapy.
Materials and Methods
In the trial involving add‐on to sulfonylureas (study 03‐1), patients were randomly assigned to receive luseogliflozin 2.5 mg or a placebo for a 24‐week double‐blind period, followed by a 28‐week open‐label period. In the open‐label trial involving add‐on to other OADs; that is, biguanides, dipeptidyl peptidase‐4 inhibitors, thiazolidinediones, glinides and α‐glucosidase inhibitors (study 03‐2), patients received luseogliflozin for 52 weeks.
Results
In study 03‐1, luseogliflozin significantly decreased glycated hemoglobin at the end of the 24‐week double‐blind period compared with the placebo (–0.88%, P < 0.001), and glycated hemoglobin reduction from baseline at week 52 was –0.63%. In study 03‐2, luseogliflozin added to other OADs significantly decreased glycated hemoglobin from baseline at week 52 (–0.52 to –0.68%, P < 0.001 for all OADs). Bodyweight reduction was observed in all add‐on therapies, even with agents associated with weight gain, such as sulfonylureas and thiazolidinediones. Most adverse events were mild in severity. When added to a sulfonylurea, incidences of hypoglycemia during the double‐blind period were 8.7% and 4.2% for luseogliflozin and placebo, respectively, but no major hypoglycemic episodes occurred. The frequency and incidences of adverse events of special interest for sodium glucose cotransporter 2 inhibitors and adverse events associated with combined OADs were acceptable.
Conclusions
Add‐on therapies of luseogliflozin to existing OADs improved glycemic control, reduced bodyweight and were well tolerated in Japanese type 2 diabetic patients. These trials were registered with the Japan Pharmaceutical Information Center (add on to sulfonylurea: JapicCTI‐111507; add on to other OADs: JapicCTI‐111508).
Add‐on therapies of luseogliflozin to existing OADs improved glycemic control, reduced body weight, and were well tolerated in Japanese patients with T2DM.</description><identifier>ISSN: 2040-1116</identifier><identifier>EISSN: 2040-1124</identifier><identifier>DOI: 10.1111/jdi.12316</identifier><identifier>PMID: 26221523</identifier><language>eng</language><publisher>Japan: John Wiley & Sons, Inc</publisher><subject>Add‐on therapy ; Antidiabetics ; Body weight gain ; Clinical trials ; Diabetes ; Diabetes mellitus ; Diabetes mellitus (non-insulin dependent) ; Dipeptidyl-peptidase IV ; Drug dosages ; Edema ; Glucose ; Hemoglobin ; Hypoglycemia ; Insulin ; Luseogliflozin ; Na+/glucose cotransporter ; Oral antidiabetic drug ; Peptidase ; Pharmaceuticals ; Sodium ; Studies ; Sulfonylurea ; Thiazolidinediones ; α-Glucosidase</subject><ispartof>Journal of diabetes investigation, 2015-07, Vol.6 (4), p.443-453</ispartof><rights>2014 Taisho Pharmaceutical Co., Ltd. Journal of Diabetes Investigation published by Asian Association of the Study of Diabetes (AASD) and Wiley Publishing Asia Pty Ltd</rights><rights>2015. This work is published under http://creativecommons.org/licenses/by-nc-nd/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><rights>2014 Taisho Pharmaceutical Co., Ltd. Journal of Diabetes Investigation published by Asian Association of the Study of Diabetes (AASD) and Wiley Publishing Asia Pty Ltd 2014</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c6426-be9c4e0ecc7327f98868734402f5ab8ef72803d90ff53b2ad21da36f03ee94663</citedby><cites>FETCH-LOGICAL-c6426-be9c4e0ecc7327f98868734402f5ab8ef72803d90ff53b2ad21da36f03ee94663</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC4511304/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC4511304/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,314,727,780,784,864,885,1417,11562,27924,27925,45574,45575,46052,46476,53791,53793</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/26221523$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Seino, Yutaka</creatorcontrib><creatorcontrib>Inagaki, Nobuya</creatorcontrib><creatorcontrib>Haneda, Masakazu</creatorcontrib><creatorcontrib>Kaku, Kohei</creatorcontrib><creatorcontrib>Sasaki, Takashi</creatorcontrib><creatorcontrib>Fukatsu, Atsushi</creatorcontrib><creatorcontrib>Ubukata, Michito</creatorcontrib><creatorcontrib>Sakai, Soichi</creatorcontrib><creatorcontrib>Samukawa, Yoshishige</creatorcontrib><title>Efficacy and safety of luseogliflozin added to various oral antidiabetic drugs in Japanese patients with type 2 diabetes mellitus</title><title>Journal of diabetes investigation</title><addtitle>J Diabetes Investig</addtitle><description>Introduction
Two studies were carried out to investigate the efficacy and safety of luseogliflozin added to existing oral antidiabetic drugs (OADs) in Japanese type 2 diabetic patients inadequately controlled with OAD monotherapy.
Materials and Methods
In the trial involving add‐on to sulfonylureas (study 03‐1), patients were randomly assigned to receive luseogliflozin 2.5 mg or a placebo for a 24‐week double‐blind period, followed by a 28‐week open‐label period. In the open‐label trial involving add‐on to other OADs; that is, biguanides, dipeptidyl peptidase‐4 inhibitors, thiazolidinediones, glinides and α‐glucosidase inhibitors (study 03‐2), patients received luseogliflozin for 52 weeks.
Results
In study 03‐1, luseogliflozin significantly decreased glycated hemoglobin at the end of the 24‐week double‐blind period compared with the placebo (–0.88%, P < 0.001), and glycated hemoglobin reduction from baseline at week 52 was –0.63%. In study 03‐2, luseogliflozin added to other OADs significantly decreased glycated hemoglobin from baseline at week 52 (–0.52 to –0.68%, P < 0.001 for all OADs). Bodyweight reduction was observed in all add‐on therapies, even with agents associated with weight gain, such as sulfonylureas and thiazolidinediones. Most adverse events were mild in severity. When added to a sulfonylurea, incidences of hypoglycemia during the double‐blind period were 8.7% and 4.2% for luseogliflozin and placebo, respectively, but no major hypoglycemic episodes occurred. The frequency and incidences of adverse events of special interest for sodium glucose cotransporter 2 inhibitors and adverse events associated with combined OADs were acceptable.
Conclusions
Add‐on therapies of luseogliflozin to existing OADs improved glycemic control, reduced bodyweight and were well tolerated in Japanese type 2 diabetic patients. These trials were registered with the Japan Pharmaceutical Information Center (add on to sulfonylurea: JapicCTI‐111507; add on to other OADs: JapicCTI‐111508).
Add‐on therapies of luseogliflozin to existing OADs improved glycemic control, reduced body weight, and were well tolerated in Japanese patients with T2DM.</description><subject>Add‐on therapy</subject><subject>Antidiabetics</subject><subject>Body weight gain</subject><subject>Clinical trials</subject><subject>Diabetes</subject><subject>Diabetes mellitus</subject><subject>Diabetes mellitus (non-insulin dependent)</subject><subject>Dipeptidyl-peptidase IV</subject><subject>Drug dosages</subject><subject>Edema</subject><subject>Glucose</subject><subject>Hemoglobin</subject><subject>Hypoglycemia</subject><subject>Insulin</subject><subject>Luseogliflozin</subject><subject>Na+/glucose cotransporter</subject><subject>Oral antidiabetic drug</subject><subject>Peptidase</subject><subject>Pharmaceuticals</subject><subject>Sodium</subject><subject>Studies</subject><subject>Sulfonylurea</subject><subject>Thiazolidinediones</subject><subject>α-Glucosidase</subject><issn>2040-1116</issn><issn>2040-1124</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2015</creationdate><recordtype>article</recordtype><sourceid>24P</sourceid><sourceid>WIN</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AZQEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><sourceid>DWQXO</sourceid><recordid>eNqNkk9rFTEUxYNYbGm78AtIwI0uXpt_k5nZCNLW2lJwo-uQSW5e85g3GZNMy7jzmxs79aFCoXeTwP3lcM_NQeg1JSe01OnG-hPKOJUv0AEjgqwoZeLl7k7lPjpOaUNK8aaRsn6F9plkjFaMH6CfF855o82M9WBx0g7yjIPD_ZQgrHvv-vDDD1hbCxbngO909GFKOETdlyfZW687yN5gG6d1woW91qMeIAEedfYw5ITvfb7FeR4BM7zwkPAW-t7nKR2hPaf7BMeP5yH69uni69nn1c2Xy6uzjzcrIwWTqw5aI4CAMTVntWuLlabmQhDmKt014GrWEG5b4lzFO6Yto1Zz6QgHaIWU_BB9WHTHqduCNWWy4kGN0W91nFXQXv3bGfytWoc7JSpKORFF4N2jQAzfJ0hZbX0yxUVxW1aiaE2oqFshqueghPOqoW1B3_6HbsIUh7IJxVjTNpWUjBbq_UKZGFKK4HZzU6J-x0CVGKiHGBT2zd9Gd-SfTy_A6QLc-x7mp5XU9fnVIvkLiP-9TQ</recordid><startdate>201507</startdate><enddate>201507</enddate><creator>Seino, Yutaka</creator><creator>Inagaki, Nobuya</creator><creator>Haneda, Masakazu</creator><creator>Kaku, Kohei</creator><creator>Sasaki, Takashi</creator><creator>Fukatsu, Atsushi</creator><creator>Ubukata, Michito</creator><creator>Sakai, Soichi</creator><creator>Samukawa, Yoshishige</creator><general>John Wiley & Sons, Inc</general><general>John Wiley & Sons, Ltd</general><scope>24P</scope><scope>WIN</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7T5</scope><scope>7TM</scope><scope>7X7</scope><scope>7XB</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>H94</scope><scope>K9.</scope><scope>M0S</scope><scope>PIMPY</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>7X8</scope><scope>5PM</scope></search><sort><creationdate>201507</creationdate><title>Efficacy and safety of luseogliflozin added to various oral antidiabetic drugs in Japanese patients with type 2 diabetes mellitus</title><author>Seino, Yutaka ; Inagaki, Nobuya ; Haneda, Masakazu ; Kaku, Kohei ; Sasaki, Takashi ; Fukatsu, Atsushi ; Ubukata, Michito ; Sakai, Soichi ; Samukawa, Yoshishige</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c6426-be9c4e0ecc7327f98868734402f5ab8ef72803d90ff53b2ad21da36f03ee94663</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2015</creationdate><topic>Add‐on therapy</topic><topic>Antidiabetics</topic><topic>Body weight gain</topic><topic>Clinical trials</topic><topic>Diabetes</topic><topic>Diabetes mellitus</topic><topic>Diabetes mellitus (non-insulin dependent)</topic><topic>Dipeptidyl-peptidase IV</topic><topic>Drug dosages</topic><topic>Edema</topic><topic>Glucose</topic><topic>Hemoglobin</topic><topic>Hypoglycemia</topic><topic>Insulin</topic><topic>Luseogliflozin</topic><topic>Na+/glucose cotransporter</topic><topic>Oral antidiabetic drug</topic><topic>Peptidase</topic><topic>Pharmaceuticals</topic><topic>Sodium</topic><topic>Studies</topic><topic>Sulfonylurea</topic><topic>Thiazolidinediones</topic><topic>α-Glucosidase</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Seino, Yutaka</creatorcontrib><creatorcontrib>Inagaki, Nobuya</creatorcontrib><creatorcontrib>Haneda, Masakazu</creatorcontrib><creatorcontrib>Kaku, Kohei</creatorcontrib><creatorcontrib>Sasaki, Takashi</creatorcontrib><creatorcontrib>Fukatsu, Atsushi</creatorcontrib><creatorcontrib>Ubukata, Michito</creatorcontrib><creatorcontrib>Sakai, Soichi</creatorcontrib><creatorcontrib>Samukawa, Yoshishige</creatorcontrib><collection>Wiley Online Library (Open Access Collection)</collection><collection>Wiley Online Library (Open Access Collection)</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Immunology Abstracts</collection><collection>Nucleic Acids Abstracts</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central Essentials</collection><collection>ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central Korea</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Access via ProQuest (Open Access)</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Journal of diabetes investigation</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Seino, Yutaka</au><au>Inagaki, Nobuya</au><au>Haneda, Masakazu</au><au>Kaku, Kohei</au><au>Sasaki, Takashi</au><au>Fukatsu, Atsushi</au><au>Ubukata, Michito</au><au>Sakai, Soichi</au><au>Samukawa, Yoshishige</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Efficacy and safety of luseogliflozin added to various oral antidiabetic drugs in Japanese patients with type 2 diabetes mellitus</atitle><jtitle>Journal of diabetes investigation</jtitle><addtitle>J Diabetes Investig</addtitle><date>2015-07</date><risdate>2015</risdate><volume>6</volume><issue>4</issue><spage>443</spage><epage>453</epage><pages>443-453</pages><issn>2040-1116</issn><eissn>2040-1124</eissn><abstract>Introduction
Two studies were carried out to investigate the efficacy and safety of luseogliflozin added to existing oral antidiabetic drugs (OADs) in Japanese type 2 diabetic patients inadequately controlled with OAD monotherapy.
Materials and Methods
In the trial involving add‐on to sulfonylureas (study 03‐1), patients were randomly assigned to receive luseogliflozin 2.5 mg or a placebo for a 24‐week double‐blind period, followed by a 28‐week open‐label period. In the open‐label trial involving add‐on to other OADs; that is, biguanides, dipeptidyl peptidase‐4 inhibitors, thiazolidinediones, glinides and α‐glucosidase inhibitors (study 03‐2), patients received luseogliflozin for 52 weeks.
Results
In study 03‐1, luseogliflozin significantly decreased glycated hemoglobin at the end of the 24‐week double‐blind period compared with the placebo (–0.88%, P < 0.001), and glycated hemoglobin reduction from baseline at week 52 was –0.63%. In study 03‐2, luseogliflozin added to other OADs significantly decreased glycated hemoglobin from baseline at week 52 (–0.52 to –0.68%, P < 0.001 for all OADs). Bodyweight reduction was observed in all add‐on therapies, even with agents associated with weight gain, such as sulfonylureas and thiazolidinediones. Most adverse events were mild in severity. When added to a sulfonylurea, incidences of hypoglycemia during the double‐blind period were 8.7% and 4.2% for luseogliflozin and placebo, respectively, but no major hypoglycemic episodes occurred. The frequency and incidences of adverse events of special interest for sodium glucose cotransporter 2 inhibitors and adverse events associated with combined OADs were acceptable.
Conclusions
Add‐on therapies of luseogliflozin to existing OADs improved glycemic control, reduced bodyweight and were well tolerated in Japanese type 2 diabetic patients. These trials were registered with the Japan Pharmaceutical Information Center (add on to sulfonylurea: JapicCTI‐111507; add on to other OADs: JapicCTI‐111508).
Add‐on therapies of luseogliflozin to existing OADs improved glycemic control, reduced body weight, and were well tolerated in Japanese patients with T2DM.</abstract><cop>Japan</cop><pub>John Wiley & Sons, Inc</pub><pmid>26221523</pmid><doi>10.1111/jdi.12316</doi><tpages>11</tpages><oa>free_for_read</oa></addata></record> |
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| source | DOAJ Directory of Open Access Journals; Access via Wiley Online Library; EZB-FREE-00999 freely available EZB journals; Wiley Online Library (Open Access Collection); PubMed Central |
| subjects | Add‐on therapy Antidiabetics Body weight gain Clinical trials Diabetes Diabetes mellitus Diabetes mellitus (non-insulin dependent) Dipeptidyl-peptidase IV Drug dosages Edema Glucose Hemoglobin Hypoglycemia Insulin Luseogliflozin Na+/glucose cotransporter Oral antidiabetic drug Peptidase Pharmaceuticals Sodium Studies Sulfonylurea Thiazolidinediones α-Glucosidase |
| title | Efficacy and safety of luseogliflozin added to various oral antidiabetic drugs in Japanese patients with type 2 diabetes mellitus |
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