A real‐world, observational study of weekly exenatide added to basal insulin in patients with type 2 diabetes mellitus (NCT02895672)

Summary Aim This is a pre‐post observational study from an endocrinology ambulatory care practice which assessed the effectiveness and safety following the addition of a glucagon‐like peptide‐1 (GLP‐1) agonist, weekly exenatide (Bydureon), to basal insulin therapy in patients with type 2 diabetes me...

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Veröffentlicht in:Endocrinology, diabetes & metabolism diabetes & metabolism, 2018-01, Vol.1 (1), p.e00004-n/a
Hauptverfasser: Stryker, Matthew D., Kane, Michael P., Busch, Robert S.
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description Summary Aim This is a pre‐post observational study from an endocrinology ambulatory care practice which assessed the effectiveness and safety following the addition of a glucagon‐like peptide‐1 (GLP‐1) agonist, weekly exenatide (Bydureon), to basal insulin therapy in patients with type 2 diabetes mellitus (T2DM). Liraglutide plus basal insulin served as a comparison group. Materials and methods A data collection form was utilized to collect study‐related information. The primary study outcome was change in HbA1c from baseline to 12 months after GLP‐1 receptor agonist therapy was added to basal insulin therapy. Secondary outcomes were change in weight, percentage of patients achieving an HbA1c of
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Liraglutide plus basal insulin served as a comparison group. Materials and methods A data collection form was utilized to collect study‐related information. The primary study outcome was change in HbA1c from baseline to 12 months after GLP‐1 receptor agonist therapy was added to basal insulin therapy. Secondary outcomes were change in weight, percentage of patients achieving an HbA1c of &lt;7% (53 mmol/mol) or ≤6.5% (48 mmol/mol) and changes in blood pressure and lipid parameters. Safety was assessed by a collection of reported adverse events. Results One‐hundred and fifty patients met inclusion criteria (seventy‐five per treatment arm). After 1 year of therapy, HbA1c decreased by 0.7% in the entire cohort (once‐weekly exenatide: −0.7%; once‐daily liraglutide: −0.8%; no significant between‐group difference). More subjects in the weekly exenatide arm achieved an HbA1c &lt; 7% (53 mmol/mol) (P = .03), but a comparable number achieved an HbA1c ≤ 6.5% (48 mmol/mol). Although significantly more patients achieved an HbA1c &lt; 7% (53 mmol/mol) in the once‐weekly exenatide arm, the baseline HbA1c was lower (7.9%) than the liraglutide arm (8.4%). No significant differences were observed between groups for other secondary outcomes. A similar number of subjects discontinued therapy, mainly due to gastrointestinal‐ill effects, and hypoglycaemia incidence did not increase compared with the previous year. Conclusion The addition of once‐weekly exenatide to basal insulin was associated with appreciable reductions in HbA1c and weight without an increase in hypoglycaemia. The addition of once‐weekly exenatide to basal insulin was associated with appreciable reductions in HbA1c and weight without an increase in hypoglycaemia.</description><identifier>ISSN: 2398-9238</identifier><identifier>EISSN: 2398-9238</identifier><identifier>DOI: 10.1002/edm2.4</identifier><identifier>PMID: 30815541</identifier><language>eng</language><publisher>England: John Wiley &amp; Sons, Inc</publisher><subject>Ambulatory care ; Antidiabetics ; basal insulin ; Diabetes ; exenatide ; glucagon‐like peptide‐1 agonist ; Hypoglycemia ; Insulin ; liraglutide ; Observational studies ; Original</subject><ispartof>Endocrinology, diabetes &amp; metabolism, 2018-01, Vol.1 (1), p.e00004-n/a</ispartof><rights>2017 The Authors. published by John Wiley &amp; Sons Ltd.</rights><rights>2018. This work is published under http://creativecommons.org/licenses/by-nc/4.0/ (the “License”). 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Liraglutide plus basal insulin served as a comparison group. Materials and methods A data collection form was utilized to collect study‐related information. The primary study outcome was change in HbA1c from baseline to 12 months after GLP‐1 receptor agonist therapy was added to basal insulin therapy. Secondary outcomes were change in weight, percentage of patients achieving an HbA1c of &lt;7% (53 mmol/mol) or ≤6.5% (48 mmol/mol) and changes in blood pressure and lipid parameters. Safety was assessed by a collection of reported adverse events. Results One‐hundred and fifty patients met inclusion criteria (seventy‐five per treatment arm). After 1 year of therapy, HbA1c decreased by 0.7% in the entire cohort (once‐weekly exenatide: −0.7%; once‐daily liraglutide: −0.8%; no significant between‐group difference). More subjects in the weekly exenatide arm achieved an HbA1c &lt; 7% (53 mmol/mol) (P = .03), but a comparable number achieved an HbA1c ≤ 6.5% (48 mmol/mol). Although significantly more patients achieved an HbA1c &lt; 7% (53 mmol/mol) in the once‐weekly exenatide arm, the baseline HbA1c was lower (7.9%) than the liraglutide arm (8.4%). No significant differences were observed between groups for other secondary outcomes. A similar number of subjects discontinued therapy, mainly due to gastrointestinal‐ill effects, and hypoglycaemia incidence did not increase compared with the previous year. Conclusion The addition of once‐weekly exenatide to basal insulin was associated with appreciable reductions in HbA1c and weight without an increase in hypoglycaemia. The addition of once‐weekly exenatide to basal insulin was associated with appreciable reductions in HbA1c and weight without an increase in hypoglycaemia.</description><subject>Ambulatory care</subject><subject>Antidiabetics</subject><subject>basal insulin</subject><subject>Diabetes</subject><subject>exenatide</subject><subject>glucagon‐like peptide‐1 agonist</subject><subject>Hypoglycemia</subject><subject>Insulin</subject><subject>liraglutide</subject><subject>Observational studies</subject><subject>Original</subject><issn>2398-9238</issn><issn>2398-9238</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2018</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>eNp10c1qFTEUB_BBLLa09REkIEgL3pqP-Ug2QrmttlB1YfchmZzY1MzkmmR6OztXrn1Gn8SUW0sVJIsTOD_-nORU1XOCjwjG9A2YgR7VT6odygRfCMr400f37Wo_pWuMMRFCtJg-q7YZ5qRparJT_ThGEZT_9f3nOkRvXqOgE8QblV0YlUcpT2ZGwaI1wFc_I7iFsfQMIGUMGJQD0ioV6MY0eTeWilYFwJgTWrt8hfK8AkSRcUpDhoQG8N7lKaGDj8tLTLlo2o4e7lVbVvkE-_d1t_r87vRyeba4-PT-fHl8sehZw-uFtbhpdGeg09bqBsAQC13PatwDaWrRc0KF6GzXWk1bw4i1IFSnFa8VELZbvd2kriY9gOnLlFF5uYpuUHGWQTn5d2d0V_JLuJEta7EgogQc3AfE8G2ClOXgUl9epEYIU5KU8A4zhikt9OU_9DpMsfxpUbRteTkUF_Vqo_oYUopgH4YhWN7tVt7tVtYFvng8-gP7s8kCDjdg7TzM_4mRpycfaM1-A7zPrn0</recordid><startdate>201801</startdate><enddate>201801</enddate><creator>Stryker, Matthew D.</creator><creator>Kane, Michael P.</creator><creator>Busch, Robert S.</creator><general>John Wiley &amp; Sons, Inc</general><general>John Wiley and Sons Inc</general><scope>24P</scope><scope>WIN</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</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>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><orcidid>https://orcid.org/0000-0002-0648-6465</orcidid></search><sort><creationdate>201801</creationdate><title>A real‐world, observational study of weekly exenatide added to basal insulin in patients with type 2 diabetes mellitus (NCT02895672)</title><author>Stryker, Matthew D. ; Kane, Michael P. ; Busch, Robert S.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c3584-ff055b7de7bffb5eed1fe7c340ce1549c812997f76fb26d31ffe9a7ba84ae13</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2018</creationdate><topic>Ambulatory care</topic><topic>Antidiabetics</topic><topic>basal insulin</topic><topic>Diabetes</topic><topic>exenatide</topic><topic>glucagon‐like peptide‐1 agonist</topic><topic>Hypoglycemia</topic><topic>Insulin</topic><topic>liraglutide</topic><topic>Observational studies</topic><topic>Original</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Stryker, Matthew D.</creatorcontrib><creatorcontrib>Kane, Michael P.</creatorcontrib><creatorcontrib>Busch, Robert S.</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>Health &amp; 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metabolism</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Stryker, Matthew D.</au><au>Kane, Michael P.</au><au>Busch, Robert S.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>A real‐world, observational study of weekly exenatide added to basal insulin in patients with type 2 diabetes mellitus (NCT02895672)</atitle><jtitle>Endocrinology, diabetes &amp; metabolism</jtitle><addtitle>Endocrinol Diabetes Metab</addtitle><date>2018-01</date><risdate>2018</risdate><volume>1</volume><issue>1</issue><spage>e00004</spage><epage>n/a</epage><pages>e00004-n/a</pages><issn>2398-9238</issn><eissn>2398-9238</eissn><abstract>Summary Aim This is a pre‐post observational study from an endocrinology ambulatory care practice which assessed the effectiveness and safety following the addition of a glucagon‐like peptide‐1 (GLP‐1) agonist, weekly exenatide (Bydureon), to basal insulin therapy in patients with type 2 diabetes mellitus (T2DM). Liraglutide plus basal insulin served as a comparison group. Materials and methods A data collection form was utilized to collect study‐related information. The primary study outcome was change in HbA1c from baseline to 12 months after GLP‐1 receptor agonist therapy was added to basal insulin therapy. Secondary outcomes were change in weight, percentage of patients achieving an HbA1c of &lt;7% (53 mmol/mol) or ≤6.5% (48 mmol/mol) and changes in blood pressure and lipid parameters. Safety was assessed by a collection of reported adverse events. Results One‐hundred and fifty patients met inclusion criteria (seventy‐five per treatment arm). After 1 year of therapy, HbA1c decreased by 0.7% in the entire cohort (once‐weekly exenatide: −0.7%; once‐daily liraglutide: −0.8%; no significant between‐group difference). More subjects in the weekly exenatide arm achieved an HbA1c &lt; 7% (53 mmol/mol) (P = .03), but a comparable number achieved an HbA1c ≤ 6.5% (48 mmol/mol). Although significantly more patients achieved an HbA1c &lt; 7% (53 mmol/mol) in the once‐weekly exenatide arm, the baseline HbA1c was lower (7.9%) than the liraglutide arm (8.4%). No significant differences were observed between groups for other secondary outcomes. A similar number of subjects discontinued therapy, mainly due to gastrointestinal‐ill effects, and hypoglycaemia incidence did not increase compared with the previous year. Conclusion The addition of once‐weekly exenatide to basal insulin was associated with appreciable reductions in HbA1c and weight without an increase in hypoglycaemia. The addition of once‐weekly exenatide to basal insulin was associated with appreciable reductions in HbA1c and weight without an increase in hypoglycaemia.</abstract><cop>England</cop><pub>John Wiley &amp; Sons, Inc</pub><pmid>30815541</pmid><doi>10.1002/edm2.4</doi><tpages>7</tpages><orcidid>https://orcid.org/0000-0002-0648-6465</orcidid><oa>free_for_read</oa></addata></record>
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subjects Ambulatory care
Antidiabetics
basal insulin
Diabetes
exenatide
glucagon‐like peptide‐1 agonist
Hypoglycemia
Insulin
liraglutide
Observational studies
Original
title A real‐world, observational study of weekly exenatide added to basal insulin in patients with type 2 diabetes mellitus (NCT02895672)
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