Efficacy and safety of vildagliptin in patients with type 2 diabetes mellitus inadequately controlled with dual combination of metformin and sulphonylurea
Aim The broadly used combination of metformin and sulphonylurea (SU) often fails to bring patients to glycaemic goal. This study assessed the efficacy and safety of vildagliptin as add‐on therapy to metformin plus glimepiride combination in patients with type 2 diabetes mellitus (T2DM) who had inade...
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| Veröffentlicht in: | Diabetes, obesity & metabolism obesity & metabolism, 2014-05, Vol.16 (5), p.403-409 |
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| creator | Lukashevich, V. Del Prato, S. Araga, M. Kothny, W. |
| description | Aim
The broadly used combination of metformin and sulphonylurea (SU) often fails to bring patients to glycaemic goal. This study assessed the efficacy and safety of vildagliptin as add‐on therapy to metformin plus glimepiride combination in patients with type 2 diabetes mellitus (T2DM) who had inadequate glycaemic control.
Methods
A multicentre, double‐blind, placebo‐controlled study randomized patients to receive treatment with vildagliptin 50 mg bid (n = 158) or placebo (n = 160) for 24 weeks.
Results
After 24 weeks, the adjusted mean change in haemoglobin A1c (HbA1c) was −1.01% with vildagliptin (baseline 8.75%) and −0.25% with placebo (baseline 8.80%), with a between‐treatment difference of −0.76% (p |
| doi_str_mv | 10.1111/dom.12229 |
| format | Article |
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The broadly used combination of metformin and sulphonylurea (SU) often fails to bring patients to glycaemic goal. This study assessed the efficacy and safety of vildagliptin as add‐on therapy to metformin plus glimepiride combination in patients with type 2 diabetes mellitus (T2DM) who had inadequate glycaemic control.
Methods
A multicentre, double‐blind, placebo‐controlled study randomized patients to receive treatment with vildagliptin 50 mg bid (n = 158) or placebo (n = 160) for 24 weeks.
Results
After 24 weeks, the adjusted mean change in haemoglobin A1c (HbA1c) was −1.01% with vildagliptin (baseline 8.75%) and −0.25% with placebo (baseline 8.80%), with a between‐treatment difference of −0.76% (p < 0.001). Significantly more patients on vildagliptin achieved the HbA1c target <7% (28.3% vs. 5.6%; p < 0.001). The difference in fasting plasma glucose reduction between vildagliptin and placebo was −1.13 mmol/l (p < 0.001). In subgroup of patients with baseline HbA1c ≤8%, vildagliptin reduced HbA1c by 0.74% from baseline 7.82% (between‐treatment difference: –0.97%; p < 0.001) with significantly more patients achieving the HbA1c target <7% (38.6% vs. 13.9%; p = 0.014). Vildagliptin was well tolerated with low incidence of hypoglycaemia, slightly higher than with placebo (5.1% vs. 1.9%) and no clinically relevant weight gain.
Conclusions
Vildagliptin significantly improved glycaemic control in patients with T2DM inadequately controlled with metformin plus glimepiride combination. The addition of vildagliptin was well tolerated with low risk of hypoglycaemia and weight gain. This makes vildagliptin an attractive treatment option for patients failing on metformin plus SU particularly in patients with baseline HbA1c ≤8%.]]></description><identifier>ISSN: 1462-8902</identifier><identifier>EISSN: 1463-1326</identifier><identifier>DOI: 10.1111/dom.12229</identifier><identifier>PMID: 24199686</identifier><identifier>CODEN: DOMEF6</identifier><language>eng</language><publisher>Oxford, UK: Blackwell Publishing Ltd</publisher><subject>Adamantane - administration & dosage ; Adamantane - adverse effects ; Adamantane - analogs & derivatives ; Adamantane - therapeutic use ; Adolescent ; Adult ; Aged ; Aged, 80 and over ; Antidiabetics ; Blood Glucose - drug effects ; Blood Glucose - metabolism ; Body Weight - drug effects ; Diabetes ; Diabetes mellitus (non-insulin dependent) ; Diabetes Mellitus, Type 2 - blood ; Diabetes Mellitus, Type 2 - drug therapy ; Dipeptidyl-Peptidase IV Inhibitors - therapeutic use ; Double-Blind Method ; DPP-4 inhibitor ; Drug Administration Schedule ; Drug Therapy, Combination ; Female ; glimepiride ; Glycated Hemoglobin A - drug effects ; Glycated Hemoglobin A - metabolism ; Hemoglobin ; Humans ; Hypoglycemia ; Hypoglycemia - blood ; Hypoglycemia - drug therapy ; Hypoglycemic Agents - administration & dosage ; Hypoglycemic Agents - adverse effects ; Hypoglycemic Agents - therapeutic use ; Insulin ; Male ; Metformin ; Metformin - therapeutic use ; Middle Aged ; Nitriles - administration & dosage ; Nitriles - adverse effects ; Nitriles - therapeutic use ; oral antidiabetic drug ; Original ; Placebos ; Pyrrolidines - administration & dosage ; Pyrrolidines - adverse effects ; Pyrrolidines - therapeutic use ; Sulfonylurea Compounds - therapeutic use ; Treatment Outcome ; type 2 diabetes ; vildagliptin</subject><ispartof>Diabetes, obesity & metabolism, 2014-05, Vol.16 (5), p.403-409</ispartof><rights>2013 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd.</rights><rights>2014 John Wiley & Sons Ltd</rights><rights>2013. This article is published under http://creativecommons.org/licenses/by-nc-nd/3.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><rights>2013 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd. 2013</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c5099-afae5bde77db3dcb99e4eed45317ee5c7624ed61da4db0a1236a78cfc16f52b23</citedby><cites>FETCH-LOGICAL-c5099-afae5bde77db3dcb99e4eed45317ee5c7624ed61da4db0a1236a78cfc16f52b23</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1111%2Fdom.12229$$EPDF$$P50$$Gwiley$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1111%2Fdom.12229$$EHTML$$P50$$Gwiley$$Hfree_for_read</linktohtml><link.rule.ids>230,314,776,780,881,1411,27901,27902,45550,45551</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/24199686$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Lukashevich, V.</creatorcontrib><creatorcontrib>Del Prato, S.</creatorcontrib><creatorcontrib>Araga, M.</creatorcontrib><creatorcontrib>Kothny, W.</creatorcontrib><title>Efficacy and safety of vildagliptin in patients with type 2 diabetes mellitus inadequately controlled with dual combination of metformin and sulphonylurea</title><title>Diabetes, obesity & metabolism</title><addtitle>Diabetes Obes Metab</addtitle><description><![CDATA[Aim
The broadly used combination of metformin and sulphonylurea (SU) often fails to bring patients to glycaemic goal. This study assessed the efficacy and safety of vildagliptin as add‐on therapy to metformin plus glimepiride combination in patients with type 2 diabetes mellitus (T2DM) who had inadequate glycaemic control.
Methods
A multicentre, double‐blind, placebo‐controlled study randomized patients to receive treatment with vildagliptin 50 mg bid (n = 158) or placebo (n = 160) for 24 weeks.
Results
After 24 weeks, the adjusted mean change in haemoglobin A1c (HbA1c) was −1.01% with vildagliptin (baseline 8.75%) and −0.25% with placebo (baseline 8.80%), with a between‐treatment difference of −0.76% (p < 0.001). Significantly more patients on vildagliptin achieved the HbA1c target <7% (28.3% vs. 5.6%; p < 0.001). The difference in fasting plasma glucose reduction between vildagliptin and placebo was −1.13 mmol/l (p < 0.001). In subgroup of patients with baseline HbA1c ≤8%, vildagliptin reduced HbA1c by 0.74% from baseline 7.82% (between‐treatment difference: –0.97%; p < 0.001) with significantly more patients achieving the HbA1c target <7% (38.6% vs. 13.9%; p = 0.014). Vildagliptin was well tolerated with low incidence of hypoglycaemia, slightly higher than with placebo (5.1% vs. 1.9%) and no clinically relevant weight gain.
Conclusions
Vildagliptin significantly improved glycaemic control in patients with T2DM inadequately controlled with metformin plus glimepiride combination. The addition of vildagliptin was well tolerated with low risk of hypoglycaemia and weight gain. This makes vildagliptin an attractive treatment option for patients failing on metformin plus SU particularly in patients with baseline HbA1c ≤8%.]]></description><subject>Adamantane - administration & dosage</subject><subject>Adamantane - adverse effects</subject><subject>Adamantane - analogs & derivatives</subject><subject>Adamantane - therapeutic use</subject><subject>Adolescent</subject><subject>Adult</subject><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Antidiabetics</subject><subject>Blood Glucose - drug effects</subject><subject>Blood Glucose - metabolism</subject><subject>Body Weight - drug effects</subject><subject>Diabetes</subject><subject>Diabetes mellitus (non-insulin dependent)</subject><subject>Diabetes Mellitus, Type 2 - blood</subject><subject>Diabetes Mellitus, Type 2 - drug therapy</subject><subject>Dipeptidyl-Peptidase IV Inhibitors - therapeutic use</subject><subject>Double-Blind Method</subject><subject>DPP-4 inhibitor</subject><subject>Drug Administration Schedule</subject><subject>Drug Therapy, Combination</subject><subject>Female</subject><subject>glimepiride</subject><subject>Glycated Hemoglobin A - drug effects</subject><subject>Glycated Hemoglobin A - metabolism</subject><subject>Hemoglobin</subject><subject>Humans</subject><subject>Hypoglycemia</subject><subject>Hypoglycemia - blood</subject><subject>Hypoglycemia - drug therapy</subject><subject>Hypoglycemic Agents - administration & dosage</subject><subject>Hypoglycemic Agents - adverse effects</subject><subject>Hypoglycemic Agents - therapeutic use</subject><subject>Insulin</subject><subject>Male</subject><subject>Metformin</subject><subject>Metformin - therapeutic use</subject><subject>Middle Aged</subject><subject>Nitriles - administration & dosage</subject><subject>Nitriles - adverse effects</subject><subject>Nitriles - therapeutic use</subject><subject>oral antidiabetic drug</subject><subject>Original</subject><subject>Placebos</subject><subject>Pyrrolidines - administration & dosage</subject><subject>Pyrrolidines - adverse effects</subject><subject>Pyrrolidines - therapeutic use</subject><subject>Sulfonylurea Compounds - therapeutic use</subject><subject>Treatment Outcome</subject><subject>type 2 diabetes</subject><subject>vildagliptin</subject><issn>1462-8902</issn><issn>1463-1326</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2014</creationdate><recordtype>article</recordtype><sourceid>24P</sourceid><sourceid>EIF</sourceid><recordid>eNp9kctu1TAURSMEoqUw4AeQJUYM0vqdZIKE-gJUqJB4SEwsJz7pdXHi1HZa8it8Le697RUMwLJky157n3O0i-I5wfskrwPjh31CKW0eFLuES1YSRuXD9Z2WdYPpTvEkxkuMMWd19bjYoZw0jazlbvHruO9tp7sF6dGgqHtIC_I9urbO6Atnp2RHlPekk4UxRXRj0wqlZQJEkbG6hQQRDeCcTXPMpDZwNesEbkGdH1PwzoHZqMysXX4c2kwl68fbOgOk3ochV1jXn9208uPi5gD6afGo1y7Cs7tzr_hycvz58G15dn767vDNWdkJ3DSl7jWI1kBVmZaZrm0a4ACGC0YqANFVknIwkhjNTYs1oUzqqu76jshe0JayveL1xnea2wFMl8cM2qkp2EGHRXlt1d8_o12pC3-tOGWVECIbvLwzCP5qhpjUpZ_DmHtWDIuGM0nr_1JEEMlqWVc8U682VBd8jAH6bR8Eq9uwVQ5brcPO7Is_G9-S9-lm4GAD3FgHy7-d1NH5h3vLcqOwMcHPrUKHH0pWeVr17eOpev_p5GtFv2PVsN8-IMg6</recordid><startdate>201405</startdate><enddate>201405</enddate><creator>Lukashevich, V.</creator><creator>Del Prato, S.</creator><creator>Araga, M.</creator><creator>Kothny, W.</creator><general>Blackwell Publishing Ltd</general><general>Wiley Subscription Services, Inc</general><scope>BSCLL</scope><scope>24P</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7T5</scope><scope>7TK</scope><scope>H94</scope><scope>K9.</scope><scope>5PM</scope></search><sort><creationdate>201405</creationdate><title>Efficacy and safety of vildagliptin in patients with type 2 diabetes mellitus inadequately controlled with dual combination of metformin and sulphonylurea</title><author>Lukashevich, V. ; Del Prato, S. ; Araga, M. ; Kothny, W.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c5099-afae5bde77db3dcb99e4eed45317ee5c7624ed61da4db0a1236a78cfc16f52b23</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2014</creationdate><topic>Adamantane - administration & dosage</topic><topic>Adamantane - adverse effects</topic><topic>Adamantane - analogs & derivatives</topic><topic>Adamantane - therapeutic use</topic><topic>Adolescent</topic><topic>Adult</topic><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>Antidiabetics</topic><topic>Blood Glucose - drug effects</topic><topic>Blood Glucose - metabolism</topic><topic>Body Weight - drug effects</topic><topic>Diabetes</topic><topic>Diabetes mellitus (non-insulin dependent)</topic><topic>Diabetes Mellitus, Type 2 - blood</topic><topic>Diabetes Mellitus, Type 2 - drug therapy</topic><topic>Dipeptidyl-Peptidase IV Inhibitors - therapeutic use</topic><topic>Double-Blind Method</topic><topic>DPP-4 inhibitor</topic><topic>Drug Administration Schedule</topic><topic>Drug Therapy, Combination</topic><topic>Female</topic><topic>glimepiride</topic><topic>Glycated Hemoglobin A - drug effects</topic><topic>Glycated Hemoglobin A - metabolism</topic><topic>Hemoglobin</topic><topic>Humans</topic><topic>Hypoglycemia</topic><topic>Hypoglycemia - blood</topic><topic>Hypoglycemia - drug therapy</topic><topic>Hypoglycemic Agents - administration & dosage</topic><topic>Hypoglycemic Agents - adverse effects</topic><topic>Hypoglycemic Agents - therapeutic use</topic><topic>Insulin</topic><topic>Male</topic><topic>Metformin</topic><topic>Metformin - therapeutic use</topic><topic>Middle Aged</topic><topic>Nitriles - administration & dosage</topic><topic>Nitriles - adverse effects</topic><topic>Nitriles - therapeutic use</topic><topic>oral antidiabetic drug</topic><topic>Original</topic><topic>Placebos</topic><topic>Pyrrolidines - administration & dosage</topic><topic>Pyrrolidines - adverse effects</topic><topic>Pyrrolidines - therapeutic use</topic><topic>Sulfonylurea Compounds - therapeutic use</topic><topic>Treatment Outcome</topic><topic>type 2 diabetes</topic><topic>vildagliptin</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Lukashevich, V.</creatorcontrib><creatorcontrib>Del Prato, S.</creatorcontrib><creatorcontrib>Araga, M.</creatorcontrib><creatorcontrib>Kothny, W.</creatorcontrib><collection>Istex</collection><collection>Wiley Online Library Open Access</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Immunology Abstracts</collection><collection>Neurosciences Abstracts</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Diabetes, obesity & metabolism</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Lukashevich, V.</au><au>Del Prato, S.</au><au>Araga, M.</au><au>Kothny, W.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Efficacy and safety of vildagliptin in patients with type 2 diabetes mellitus inadequately controlled with dual combination of metformin and sulphonylurea</atitle><jtitle>Diabetes, obesity & metabolism</jtitle><addtitle>Diabetes Obes Metab</addtitle><date>2014-05</date><risdate>2014</risdate><volume>16</volume><issue>5</issue><spage>403</spage><epage>409</epage><pages>403-409</pages><issn>1462-8902</issn><eissn>1463-1326</eissn><coden>DOMEF6</coden><abstract><![CDATA[Aim
The broadly used combination of metformin and sulphonylurea (SU) often fails to bring patients to glycaemic goal. This study assessed the efficacy and safety of vildagliptin as add‐on therapy to metformin plus glimepiride combination in patients with type 2 diabetes mellitus (T2DM) who had inadequate glycaemic control.
Methods
A multicentre, double‐blind, placebo‐controlled study randomized patients to receive treatment with vildagliptin 50 mg bid (n = 158) or placebo (n = 160) for 24 weeks.
Results
After 24 weeks, the adjusted mean change in haemoglobin A1c (HbA1c) was −1.01% with vildagliptin (baseline 8.75%) and −0.25% with placebo (baseline 8.80%), with a between‐treatment difference of −0.76% (p < 0.001). Significantly more patients on vildagliptin achieved the HbA1c target <7% (28.3% vs. 5.6%; p < 0.001). The difference in fasting plasma glucose reduction between vildagliptin and placebo was −1.13 mmol/l (p < 0.001). In subgroup of patients with baseline HbA1c ≤8%, vildagliptin reduced HbA1c by 0.74% from baseline 7.82% (between‐treatment difference: –0.97%; p < 0.001) with significantly more patients achieving the HbA1c target <7% (38.6% vs. 13.9%; p = 0.014). Vildagliptin was well tolerated with low incidence of hypoglycaemia, slightly higher than with placebo (5.1% vs. 1.9%) and no clinically relevant weight gain.
Conclusions
Vildagliptin significantly improved glycaemic control in patients with T2DM inadequately controlled with metformin plus glimepiride combination. The addition of vildagliptin was well tolerated with low risk of hypoglycaemia and weight gain. This makes vildagliptin an attractive treatment option for patients failing on metformin plus SU particularly in patients with baseline HbA1c ≤8%.]]></abstract><cop>Oxford, UK</cop><pub>Blackwell Publishing Ltd</pub><pmid>24199686</pmid><doi>10.1111/dom.12229</doi><tpages>7</tpages><oa>free_for_read</oa></addata></record> |
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| ispartof | Diabetes, obesity & metabolism, 2014-05, Vol.16 (5), p.403-409 |
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| source | MEDLINE; Wiley Online Library Journals Frontfile Complete |
| subjects | Adamantane - administration & dosage Adamantane - adverse effects Adamantane - analogs & derivatives Adamantane - therapeutic use Adolescent Adult Aged Aged, 80 and over Antidiabetics Blood Glucose - drug effects Blood Glucose - metabolism Body Weight - drug effects Diabetes Diabetes mellitus (non-insulin dependent) Diabetes Mellitus, Type 2 - blood Diabetes Mellitus, Type 2 - drug therapy Dipeptidyl-Peptidase IV Inhibitors - therapeutic use Double-Blind Method DPP-4 inhibitor Drug Administration Schedule Drug Therapy, Combination Female glimepiride Glycated Hemoglobin A - drug effects Glycated Hemoglobin A - metabolism Hemoglobin Humans Hypoglycemia Hypoglycemia - blood Hypoglycemia - drug therapy Hypoglycemic Agents - administration & dosage Hypoglycemic Agents - adverse effects Hypoglycemic Agents - therapeutic use Insulin Male Metformin Metformin - therapeutic use Middle Aged Nitriles - administration & dosage Nitriles - adverse effects Nitriles - therapeutic use oral antidiabetic drug Original Placebos Pyrrolidines - administration & dosage Pyrrolidines - adverse effects Pyrrolidines - therapeutic use Sulfonylurea Compounds - therapeutic use Treatment Outcome type 2 diabetes vildagliptin |
| title | Efficacy and safety of vildagliptin in patients with type 2 diabetes mellitus inadequately controlled with dual combination of metformin and sulphonylurea |
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