Efficacy and Safety of Canagliflozin Used in Conjunction with Sulfonylurea in Patients with Type 2 Diabetes Mellitus: A Randomized, Controlled Trial
Introduction The efficacy and safety of canagliflozin, a sodium glucose co-transporter 2 (SGLT2) inhibitor, was evaluated in patients with type 2 diabetes mellitus (T2DM) inadequately controlled on sulfonylurea monotherapy. Methods The CANagliflozin cardioVascular Assessment Study (CANVAS) is a doub...
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| Veröffentlicht in: | Diabetes therapy 2015-09, Vol.6 (3), p.289-302 |
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| creator | Fulcher, Greg Matthews, David R. Perkovic, Vlado de Zeeuw, Dick Mahaffey, Kenneth W. Weiss, Robert Rosenstock, Julio Capuano, George Desai, Mehul Shaw, Wayne Vercruysse, Frank Meininger, Gary Neal, Bruce |
| description | Introduction
The efficacy and safety of canagliflozin, a sodium glucose co-transporter 2 (SGLT2) inhibitor, was evaluated in patients with type 2 diabetes mellitus (T2DM) inadequately controlled on sulfonylurea monotherapy.
Methods
The CANagliflozin cardioVascular Assessment Study (CANVAS) is a double-blind, placebo-controlled cardiovascular outcomes study that randomized participants to placebo or canagliflozin 100 or 300 mg once daily in addition to routine therapy. Participants in the CANVAS trial are men and women aged ≥30 years with T2DM and a history or high risk of cardiovascular disease, and inadequate glycemic control (glycated hemoglobin [HbA1c] ≥7.0% and ≤10.5%) on current antihyperglycemic therapies. The primary objective of this prespecified substudy was to assess change from baseline to 18 weeks in HbA1c among patients on sulfonylurea monotherapy.
Results
Of the 4330 patients enrolled in CANVAS, 127 met the entry criteria for the sulfonylurea monotherapy substudy (placebo,
n
= 45; canagliflozin 100 mg,
n
= 42; canagliflozin 300 mg,
n
= 40). At 18 weeks, placebo-subtracted changes (95% confidence interval) in HbA1c were −0.74% (−1.15, −0.33;
P
|
| doi_str_mv | 10.1007/s13300-015-0117-z |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_pubme</sourceid><recordid>TN_cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_4575303</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>3811484081</sourcerecordid><originalsourceid>FETCH-LOGICAL-c470t-ede19edf83e6a91f9e36020bae0a5da85c8dec33adc0efcb31f72ceed6c4ff983</originalsourceid><addsrcrecordid>eNp1kd9qVDEQxg9isaXtA3gjAW-88Njk5PyLF0JZWy1UFLu9Dtlkss2STbZJjnL2OfrAZj11qYKBMAPzm29m-IriJcHvCMbdWSSUYlxi0uRPunL7rDgifcvKlrXk-T5v6GFxGuMK50cZY4S8KA6rFvekY_SoeLjQ2kghRyScQjdCQxqR12gmnFhao63fGoduIyiU48y71eBkMt6hnybdoZvBau9GOwQQO-CbSAZcilN1Pm4AVeijEQtIENEXsNakIb5H5-h7nufXZgvq7U42BW9tHjIPRtiT4kALG-H0MR4Xt5cX89nn8vrrp6vZ-XUp6w6nEhQQBkr3FFrBiGZAW1zhhQAsGiX6RvYKJKVCSQxaLijRXSUBVCtrrVlPj4sPk-5mWKxBybx5EJZvglmLMHIvDP-74swdX_ofvG66hmKaBd48CgR_P0BMfG2izFcKB36InHSEsrquqy6jr_9BV34ILp_3m-qyXF9likyUDD7GAHq_DMF8ZzufbOfZdr6znW9zz6unV-w7_picgWoCYi65JYQno_-r-gv36rx_</addsrcrecordid><sourcetype>Open Access Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>1713730382</pqid></control><display><type>article</type><title>Efficacy and Safety of Canagliflozin Used in Conjunction with Sulfonylurea in Patients with Type 2 Diabetes Mellitus: A Randomized, Controlled Trial</title><source>SpringerOpen</source><source>DOAJ Directory of Open Access Journals</source><source>PubMed Central</source><source>EZB Electronic Journals Library</source><creator>Fulcher, Greg ; Matthews, David R. ; Perkovic, Vlado ; de Zeeuw, Dick ; Mahaffey, Kenneth W. ; Weiss, Robert ; Rosenstock, Julio ; Capuano, George ; Desai, Mehul ; Shaw, Wayne ; Vercruysse, Frank ; Meininger, Gary ; Neal, Bruce</creator><creatorcontrib>Fulcher, Greg ; Matthews, David R. ; Perkovic, Vlado ; de Zeeuw, Dick ; Mahaffey, Kenneth W. ; Weiss, Robert ; Rosenstock, Julio ; Capuano, George ; Desai, Mehul ; Shaw, Wayne ; Vercruysse, Frank ; Meininger, Gary ; Neal, Bruce</creatorcontrib><description>Introduction
The efficacy and safety of canagliflozin, a sodium glucose co-transporter 2 (SGLT2) inhibitor, was evaluated in patients with type 2 diabetes mellitus (T2DM) inadequately controlled on sulfonylurea monotherapy.
Methods
The CANagliflozin cardioVascular Assessment Study (CANVAS) is a double-blind, placebo-controlled cardiovascular outcomes study that randomized participants to placebo or canagliflozin 100 or 300 mg once daily in addition to routine therapy. Participants in the CANVAS trial are men and women aged ≥30 years with T2DM and a history or high risk of cardiovascular disease, and inadequate glycemic control (glycated hemoglobin [HbA1c] ≥7.0% and ≤10.5%) on current antihyperglycemic therapies. The primary objective of this prespecified substudy was to assess change from baseline to 18 weeks in HbA1c among patients on sulfonylurea monotherapy.
Results
Of the 4330 patients enrolled in CANVAS, 127 met the entry criteria for the sulfonylurea monotherapy substudy (placebo,
n
= 45; canagliflozin 100 mg,
n
= 42; canagliflozin 300 mg,
n
= 40). At 18 weeks, placebo-subtracted changes (95% confidence interval) in HbA1c were −0.74% (−1.15, −0.33;
P
< 0.001) and −0.83% (−1.24, −0.42;
P
< 0.001) with canagliflozin 100 and 300 mg, respectively. Relative to placebo, canagliflozin 100 and 300 mg also decreased fasting plasma glucose (FPG; −2.1 mmol/L [−3.0, −1.2] and −2.7 mmol/L [−3.6, −1.7], respectively). Body weight was lower with canagliflozin 300 mg (–1.8% [−3.2, −0.4];
P
= 0.014) but unchanged with canagliflozin 100 mg (−0.4% [−1.8, 1.0];
P
= 0.557). Canagliflozin 300 mg increased hypoglycemia episodes compared to canagliflozin 100 mg and placebo (15%, 0%, and 4.4%, respectively). Adverse events (AEs) of male and female genital mycotic infections, pollakiuria, and thirst were more common with canagliflozin.
Conclusions
Canagliflozin added to ongoing sulfonylurea monotherapy produced improvements in HbA1c, FPG, and body weight, with an increased incidence of AEs consistent with the mechanism of action of SGLT2 inhibition.
Funding
Janssen Research & Development, LLC.
Clinical trial registration: ClinicalTrials.gov NCT01032629.</description><identifier>ISSN: 1869-6953</identifier><identifier>EISSN: 1869-6961</identifier><identifier>DOI: 10.1007/s13300-015-0117-z</identifier><identifier>PMID: 26081793</identifier><language>eng</language><publisher>Cheshire: Springer Healthcare</publisher><subject>Cardiology ; Diabetes ; Drug therapy ; Endocrinology ; Internal Medicine ; Medicine ; Medicine & Public Health ; Original Research</subject><ispartof>Diabetes therapy, 2015-09, Vol.6 (3), p.289-302</ispartof><rights>The Author(s) 2015</rights><rights>Springer Healthcare 2015</rights><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c470t-ede19edf83e6a91f9e36020bae0a5da85c8dec33adc0efcb31f72ceed6c4ff983</citedby><cites>FETCH-LOGICAL-c470t-ede19edf83e6a91f9e36020bae0a5da85c8dec33adc0efcb31f72ceed6c4ff983</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/PMC4575303/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC4575303/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,314,727,780,784,864,885,27922,27923,41118,42187,51574,53789,53791</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/26081793$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Fulcher, Greg</creatorcontrib><creatorcontrib>Matthews, David R.</creatorcontrib><creatorcontrib>Perkovic, Vlado</creatorcontrib><creatorcontrib>de Zeeuw, Dick</creatorcontrib><creatorcontrib>Mahaffey, Kenneth W.</creatorcontrib><creatorcontrib>Weiss, Robert</creatorcontrib><creatorcontrib>Rosenstock, Julio</creatorcontrib><creatorcontrib>Capuano, George</creatorcontrib><creatorcontrib>Desai, Mehul</creatorcontrib><creatorcontrib>Shaw, Wayne</creatorcontrib><creatorcontrib>Vercruysse, Frank</creatorcontrib><creatorcontrib>Meininger, Gary</creatorcontrib><creatorcontrib>Neal, Bruce</creatorcontrib><title>Efficacy and Safety of Canagliflozin Used in Conjunction with Sulfonylurea in Patients with Type 2 Diabetes Mellitus: A Randomized, Controlled Trial</title><title>Diabetes therapy</title><addtitle>Diabetes Ther</addtitle><addtitle>Diabetes Ther</addtitle><description>Introduction
The efficacy and safety of canagliflozin, a sodium glucose co-transporter 2 (SGLT2) inhibitor, was evaluated in patients with type 2 diabetes mellitus (T2DM) inadequately controlled on sulfonylurea monotherapy.
Methods
The CANagliflozin cardioVascular Assessment Study (CANVAS) is a double-blind, placebo-controlled cardiovascular outcomes study that randomized participants to placebo or canagliflozin 100 or 300 mg once daily in addition to routine therapy. Participants in the CANVAS trial are men and women aged ≥30 years with T2DM and a history or high risk of cardiovascular disease, and inadequate glycemic control (glycated hemoglobin [HbA1c] ≥7.0% and ≤10.5%) on current antihyperglycemic therapies. The primary objective of this prespecified substudy was to assess change from baseline to 18 weeks in HbA1c among patients on sulfonylurea monotherapy.
Results
Of the 4330 patients enrolled in CANVAS, 127 met the entry criteria for the sulfonylurea monotherapy substudy (placebo,
n
= 45; canagliflozin 100 mg,
n
= 42; canagliflozin 300 mg,
n
= 40). At 18 weeks, placebo-subtracted changes (95% confidence interval) in HbA1c were −0.74% (−1.15, −0.33;
P
< 0.001) and −0.83% (−1.24, −0.42;
P
< 0.001) with canagliflozin 100 and 300 mg, respectively. Relative to placebo, canagliflozin 100 and 300 mg also decreased fasting plasma glucose (FPG; −2.1 mmol/L [−3.0, −1.2] and −2.7 mmol/L [−3.6, −1.7], respectively). Body weight was lower with canagliflozin 300 mg (–1.8% [−3.2, −0.4];
P
= 0.014) but unchanged with canagliflozin 100 mg (−0.4% [−1.8, 1.0];
P
= 0.557). Canagliflozin 300 mg increased hypoglycemia episodes compared to canagliflozin 100 mg and placebo (15%, 0%, and 4.4%, respectively). Adverse events (AEs) of male and female genital mycotic infections, pollakiuria, and thirst were more common with canagliflozin.
Conclusions
Canagliflozin added to ongoing sulfonylurea monotherapy produced improvements in HbA1c, FPG, and body weight, with an increased incidence of AEs consistent with the mechanism of action of SGLT2 inhibition.
Funding
Janssen Research & Development, LLC.
Clinical trial registration: ClinicalTrials.gov NCT01032629.</description><subject>Cardiology</subject><subject>Diabetes</subject><subject>Drug therapy</subject><subject>Endocrinology</subject><subject>Internal Medicine</subject><subject>Medicine</subject><subject>Medicine & Public Health</subject><subject>Original Research</subject><issn>1869-6953</issn><issn>1869-6961</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2015</creationdate><recordtype>article</recordtype><sourceid>C6C</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AZQEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><sourceid>DWQXO</sourceid><recordid>eNp1kd9qVDEQxg9isaXtA3gjAW-88Njk5PyLF0JZWy1UFLu9Dtlkss2STbZJjnL2OfrAZj11qYKBMAPzm29m-IriJcHvCMbdWSSUYlxi0uRPunL7rDgifcvKlrXk-T5v6GFxGuMK50cZY4S8KA6rFvekY_SoeLjQ2kghRyScQjdCQxqR12gmnFhao63fGoduIyiU48y71eBkMt6hnybdoZvBau9GOwQQO-CbSAZcilN1Pm4AVeijEQtIENEXsNakIb5H5-h7nufXZgvq7U42BW9tHjIPRtiT4kALG-H0MR4Xt5cX89nn8vrrp6vZ-XUp6w6nEhQQBkr3FFrBiGZAW1zhhQAsGiX6RvYKJKVCSQxaLijRXSUBVCtrrVlPj4sPk-5mWKxBybx5EJZvglmLMHIvDP-74swdX_ofvG66hmKaBd48CgR_P0BMfG2izFcKB36InHSEsrquqy6jr_9BV34ILp_3m-qyXF9likyUDD7GAHq_DMF8ZzufbOfZdr6znW9zz6unV-w7_picgWoCYi65JYQno_-r-gv36rx_</recordid><startdate>20150901</startdate><enddate>20150901</enddate><creator>Fulcher, Greg</creator><creator>Matthews, David R.</creator><creator>Perkovic, Vlado</creator><creator>de Zeeuw, Dick</creator><creator>Mahaffey, Kenneth W.</creator><creator>Weiss, Robert</creator><creator>Rosenstock, Julio</creator><creator>Capuano, George</creator><creator>Desai, Mehul</creator><creator>Shaw, Wayne</creator><creator>Vercruysse, Frank</creator><creator>Meininger, Gary</creator><creator>Neal, Bruce</creator><general>Springer Healthcare</general><general>Springer Nature B.V</general><scope>C6C</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7RV</scope><scope>7X7</scope><scope>7XB</scope><scope>8AO</scope><scope>8C1</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>K9-</scope><scope>K9.</scope><scope>KB0</scope><scope>M0R</scope><scope>M0S</scope><scope>NAPCQ</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>20150901</creationdate><title>Efficacy and Safety of Canagliflozin Used in Conjunction with Sulfonylurea in Patients with Type 2 Diabetes Mellitus: A Randomized, Controlled Trial</title><author>Fulcher, Greg ; Matthews, David R. ; Perkovic, Vlado ; de Zeeuw, Dick ; Mahaffey, Kenneth W. ; Weiss, Robert ; Rosenstock, Julio ; Capuano, George ; Desai, Mehul ; Shaw, Wayne ; Vercruysse, Frank ; Meininger, Gary ; Neal, Bruce</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c470t-ede19edf83e6a91f9e36020bae0a5da85c8dec33adc0efcb31f72ceed6c4ff983</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2015</creationdate><topic>Cardiology</topic><topic>Diabetes</topic><topic>Drug therapy</topic><topic>Endocrinology</topic><topic>Internal Medicine</topic><topic>Medicine</topic><topic>Medicine & Public Health</topic><topic>Original Research</topic><toplevel>online_resources</toplevel><creatorcontrib>Fulcher, Greg</creatorcontrib><creatorcontrib>Matthews, David R.</creatorcontrib><creatorcontrib>Perkovic, Vlado</creatorcontrib><creatorcontrib>de Zeeuw, Dick</creatorcontrib><creatorcontrib>Mahaffey, Kenneth W.</creatorcontrib><creatorcontrib>Weiss, Robert</creatorcontrib><creatorcontrib>Rosenstock, Julio</creatorcontrib><creatorcontrib>Capuano, George</creatorcontrib><creatorcontrib>Desai, Mehul</creatorcontrib><creatorcontrib>Shaw, Wayne</creatorcontrib><creatorcontrib>Vercruysse, Frank</creatorcontrib><creatorcontrib>Meininger, Gary</creatorcontrib><creatorcontrib>Neal, Bruce</creatorcontrib><collection>SpringerOpen</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Nursing & Allied Health Database</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>ProQuest Pharma Collection</collection><collection>Public Health Database</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)</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>Consumer Health Database (Alumni Edition)</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>Consumer Health Database</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Nursing & Allied Health Premium</collection><collection>Publicly Available Content Database</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>Diabetes therapy</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Fulcher, Greg</au><au>Matthews, David R.</au><au>Perkovic, Vlado</au><au>de Zeeuw, Dick</au><au>Mahaffey, Kenneth W.</au><au>Weiss, Robert</au><au>Rosenstock, Julio</au><au>Capuano, George</au><au>Desai, Mehul</au><au>Shaw, Wayne</au><au>Vercruysse, Frank</au><au>Meininger, Gary</au><au>Neal, Bruce</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Efficacy and Safety of Canagliflozin Used in Conjunction with Sulfonylurea in Patients with Type 2 Diabetes Mellitus: A Randomized, Controlled Trial</atitle><jtitle>Diabetes therapy</jtitle><stitle>Diabetes Ther</stitle><addtitle>Diabetes Ther</addtitle><date>2015-09-01</date><risdate>2015</risdate><volume>6</volume><issue>3</issue><spage>289</spage><epage>302</epage><pages>289-302</pages><issn>1869-6953</issn><eissn>1869-6961</eissn><abstract>Introduction
The efficacy and safety of canagliflozin, a sodium glucose co-transporter 2 (SGLT2) inhibitor, was evaluated in patients with type 2 diabetes mellitus (T2DM) inadequately controlled on sulfonylurea monotherapy.
Methods
The CANagliflozin cardioVascular Assessment Study (CANVAS) is a double-blind, placebo-controlled cardiovascular outcomes study that randomized participants to placebo or canagliflozin 100 or 300 mg once daily in addition to routine therapy. Participants in the CANVAS trial are men and women aged ≥30 years with T2DM and a history or high risk of cardiovascular disease, and inadequate glycemic control (glycated hemoglobin [HbA1c] ≥7.0% and ≤10.5%) on current antihyperglycemic therapies. The primary objective of this prespecified substudy was to assess change from baseline to 18 weeks in HbA1c among patients on sulfonylurea monotherapy.
Results
Of the 4330 patients enrolled in CANVAS, 127 met the entry criteria for the sulfonylurea monotherapy substudy (placebo,
n
= 45; canagliflozin 100 mg,
n
= 42; canagliflozin 300 mg,
n
= 40). At 18 weeks, placebo-subtracted changes (95% confidence interval) in HbA1c were −0.74% (−1.15, −0.33;
P
< 0.001) and −0.83% (−1.24, −0.42;
P
< 0.001) with canagliflozin 100 and 300 mg, respectively. Relative to placebo, canagliflozin 100 and 300 mg also decreased fasting plasma glucose (FPG; −2.1 mmol/L [−3.0, −1.2] and −2.7 mmol/L [−3.6, −1.7], respectively). Body weight was lower with canagliflozin 300 mg (–1.8% [−3.2, −0.4];
P
= 0.014) but unchanged with canagliflozin 100 mg (−0.4% [−1.8, 1.0];
P
= 0.557). Canagliflozin 300 mg increased hypoglycemia episodes compared to canagliflozin 100 mg and placebo (15%, 0%, and 4.4%, respectively). Adverse events (AEs) of male and female genital mycotic infections, pollakiuria, and thirst were more common with canagliflozin.
Conclusions
Canagliflozin added to ongoing sulfonylurea monotherapy produced improvements in HbA1c, FPG, and body weight, with an increased incidence of AEs consistent with the mechanism of action of SGLT2 inhibition.
Funding
Janssen Research & Development, LLC.
Clinical trial registration: ClinicalTrials.gov NCT01032629.</abstract><cop>Cheshire</cop><pub>Springer Healthcare</pub><pmid>26081793</pmid><doi>10.1007/s13300-015-0117-z</doi><tpages>14</tpages><oa>free_for_read</oa></addata></record> |
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| ispartof | Diabetes therapy, 2015-09, Vol.6 (3), p.289-302 |
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| source | SpringerOpen; DOAJ Directory of Open Access Journals; PubMed Central; EZB Electronic Journals Library |
| subjects | Cardiology Diabetes Drug therapy Endocrinology Internal Medicine Medicine Medicine & Public Health Original Research |
| title | Efficacy and Safety of Canagliflozin Used in Conjunction with Sulfonylurea in Patients with Type 2 Diabetes Mellitus: A Randomized, Controlled Trial |
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