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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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 |
doi_str_mv | 10.1002/edm2.4 |
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fullrecord | <record><control><sourceid>proquest_pubme</sourceid><recordid>TN_cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_6360919</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>2187033022</sourcerecordid><originalsourceid>FETCH-LOGICAL-c3584-ff055b7de7bffb5eed1fe7c340ce1549c812997f76fb26d31ffe9a7ba84ae13</originalsourceid><addsrcrecordid>eNp10c1qFTEUB_BBLLa09REkIEgL3pqP-Ug2QrmttlB1YfchmZzY1MzkmmR6OztXrn1Gn8SUW0sVJIsTOD_-nORU1XOCjwjG9A2YgR7VT6odygRfCMr400f37Wo_pWuMMRFCtJg-q7YZ5qRparJT_ThGEZT_9f3nOkRvXqOgE8QblV0YlUcpT2ZGwaI1wFc_I7iFsfQMIGUMGJQD0ioV6MY0eTeWilYFwJgTWrt8hfK8AkSRcUpDhoQG8N7lKaGDj8tLTLlo2o4e7lVbVvkE-_d1t_r87vRyeba4-PT-fHl8sehZw-uFtbhpdGeg09bqBsAQC13PatwDaWrRc0KF6GzXWk1bw4i1IFSnFa8VELZbvd2kriY9gOnLlFF5uYpuUHGWQTn5d2d0V_JLuJEta7EgogQc3AfE8G2ClOXgUl9epEYIU5KU8A4zhikt9OU_9DpMsfxpUbRteTkUF_Vqo_oYUopgH4YhWN7tVt7tVtYFvng8-gP7s8kCDjdg7TzM_4mRpycfaM1-A7zPrn0</addsrcrecordid><sourcetype>Open Access Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2266868620</pqid></control><display><type>article</type><title>A real‐world, observational study of weekly exenatide added to basal insulin in patients with type 2 diabetes mellitus (NCT02895672)</title><source>DOAJ Directory of Open Access Journals</source><source>Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals</source><source>Access via Wiley Online Library</source><source>Wiley Online Library (Open Access Collection)</source><source>PubMed Central</source><creator>Stryker, Matthew D. ; Kane, Michael P. ; Busch, Robert S.</creator><creatorcontrib>Stryker, Matthew D. ; Kane, Michael P. ; Busch, Robert S.</creatorcontrib><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 <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 < 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 < 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 & 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 & metabolism, 2018-01, Vol.1 (1), p.e00004-n/a</ispartof><rights>2017 The Authors. published by John Wiley & Sons Ltd.</rights><rights>2018. This work is published under http://creativecommons.org/licenses/by-nc/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c3584-ff055b7de7bffb5eed1fe7c340ce1549c812997f76fb26d31ffe9a7ba84ae13</citedby><cites>FETCH-LOGICAL-c3584-ff055b7de7bffb5eed1fe7c340ce1549c812997f76fb26d31ffe9a7ba84ae13</cites><orcidid>0000-0002-0648-6465</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC6360919/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC6360919/$$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/30815541$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Stryker, Matthew D.</creatorcontrib><creatorcontrib>Kane, Michael P.</creatorcontrib><creatorcontrib>Busch, Robert S.</creatorcontrib><title>A real‐world, observational study of weekly exenatide added to basal insulin in patients with type 2 diabetes mellitus (NCT02895672)</title><title>Endocrinology, diabetes & metabolism</title><addtitle>Endocrinol Diabetes Metab</addtitle><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 <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 < 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 < 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 & 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 & 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>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>Endocrinology, diabetes & 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 & 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 <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 < 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 < 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 & 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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