Patient-Reported Outcomes with Insulin Glargine 300 U/mL in People with Type 2 Diabetes: The MAGE Multicenter Observational Study

Introduction MAGE was a Multicenter, single-Arm, observational 6-month (plus 6-month extension) study that aimed to assess treatment satisfaction, efficacy, and safety of insulin Glargine 300 U/mL (Gla-300) in people with type 2 diabetes (T2DM) receiving basal-bolus insulin in a rEal-world setting....

Ausführliche Beschreibung

Gespeichert in:
Bibliographische Detailangaben
Veröffentlicht in:Diabetes therapy 2020-08, Vol.11 (8), p.1835-1847
Hauptverfasser: Colin, Ides M., Alexandre, Kathy, Bruhwyler, Jacques, Scheen, André, Verhaegen, Ann
Format: Artikel
Sprache:eng
Schlagworte:
Online-Zugang:Volltext
Tags: Tag hinzufügen
Keine Tags, Fügen Sie den ersten Tag hinzu!
container_end_page 1847
container_issue 8
container_start_page 1835
container_title Diabetes therapy
container_volume 11
creator Colin, Ides M.
Alexandre, Kathy
Bruhwyler, Jacques
Scheen, André
Verhaegen, Ann
description Introduction MAGE was a Multicenter, single-Arm, observational 6-month (plus 6-month extension) study that aimed to assess treatment satisfaction, efficacy, and safety of insulin Glargine 300 U/mL (Gla-300) in people with type 2 diabetes (T2DM) receiving basal-bolus insulin in a rEal-world setting. Materials and methods Participants were at least 18 years old, with T2DM for more than 1 year, HbA 1c 7.0–10.0%. The primary endpoint was change in Diabetes Treatment Satisfaction Questionnaire status version (DTSQs) total score (baseline to month 6). Secondary endpoints included reasons for starting Gla-300, changes in the DTSQ change version (DTSQc) total score, Hypoglycemia Fear Survey-II (HFS-II) total behavior and worry scores at months 6 and 12, HbA 1c changes at months 3, 6, 9, and 12, and safety. Results MAGE included 87 adults (mean T2DM duration 17 years). The primary endpoint of DTSQs mean (standard deviation) total score improvement at month 6 was achieved (2.80 [5.46] points; p  
doi_str_mv 10.1007/s13300-020-00866-2
format Article
fullrecord <record><control><sourceid>proquest_pubme</sourceid><recordid>TN_cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_7376812</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>2512386033</sourcerecordid><originalsourceid>FETCH-LOGICAL-c495t-f6bf50e1ae3ba47b95a9dc91bbd1854a87df1d94c0ac412d6db109649852cbaa3</originalsourceid><addsrcrecordid>eNp9ks1q3DAUhU1paUKaF-hK0E03bvRjy1YXhZCkk8CECe1kLST72qMgW65kT5l1XyTPkieLMg7pz6ICISF995wrcZLkPcGfCMbFSSCMYZxiGicuOU_pq-SQlFykXHDy-mWfs4PkOIQ7HAcTQhDyNjlglGeMMHyY_LpRo4F-TL_B4PwINVpNY-U6COinGTfoqg-TNT1aWOVb0wOKpg_3tyfdEsXTG3CDhZlc7wZ4uKfo3CgNI4TPaL0BdH26uEDXkx1NFV3Ao5UO4LfR1PXKou_jVO_eJW8aZQMcP69Hye3Xi_XZZbpcLa7OTpdplYl8TBuumxwDUcC0ygotciXqShCta1LmmSqLuiG1yCqsqozQmteaYMEzUea00kqxo-TLrDtMuoP6qSGvrBy86ZTfSaeM_PumNxvZuq0sWMFLQqMAmwWsgRak89rILd0X7veTbaWqpAZJKS8lzYRgeaz6-Gzr3Y8Jwig7EyqwVvXgphAxSjHOKC4i-uEf9M5NPn5UpPLYQMkxY5GiM1V5F4KH5uUJBMuncMg5HDKGQ-7DIf_oPUS4b8H_lv5P1SO8VLzq</addsrcrecordid><sourcetype>Open Access Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2512386033</pqid></control><display><type>article</type><title>Patient-Reported Outcomes with Insulin Glargine 300 U/mL in People with Type 2 Diabetes: The MAGE Multicenter Observational Study</title><source>DOAJ Directory of Open Access Journals</source><source>Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals</source><source>PubMed Central</source><source>Springer Nature OA Free Journals</source><creator>Colin, Ides M. ; Alexandre, Kathy ; Bruhwyler, Jacques ; Scheen, André ; Verhaegen, Ann</creator><creatorcontrib>Colin, Ides M. ; Alexandre, Kathy ; Bruhwyler, Jacques ; Scheen, André ; Verhaegen, Ann</creatorcontrib><description>Introduction MAGE was a Multicenter, single-Arm, observational 6-month (plus 6-month extension) study that aimed to assess treatment satisfaction, efficacy, and safety of insulin Glargine 300 U/mL (Gla-300) in people with type 2 diabetes (T2DM) receiving basal-bolus insulin in a rEal-world setting. Materials and methods Participants were at least 18 years old, with T2DM for more than 1 year, HbA 1c 7.0–10.0%. The primary endpoint was change in Diabetes Treatment Satisfaction Questionnaire status version (DTSQs) total score (baseline to month 6). Secondary endpoints included reasons for starting Gla-300, changes in the DTSQ change version (DTSQc) total score, Hypoglycemia Fear Survey-II (HFS-II) total behavior and worry scores at months 6 and 12, HbA 1c changes at months 3, 6, 9, and 12, and safety. Results MAGE included 87 adults (mean T2DM duration 17 years). The primary endpoint of DTSQs mean (standard deviation) total score improvement at month 6 was achieved (2.80 [5.46] points; p  &lt; 0.0001). The main reasons for Gla-300 initiation were to decrease HbA 1c (89.7% of participants) and reduce the number of hypoglycemic events (35.6% of participants). Significant improvements were observed in the DTSQc total score and perceived hyperglycemia/hypoglycemia (baseline to month 6, p  &lt; 0.05). Significant changes in HFS-II behavior, worry, and total scores at 6 and 12 months were also observed ( p  &lt; 0.05). There were no statistically significant changes in HbA 1c . Safety outcomes, including hypoglycemia, were comparable to previously reported trials. Conclusions The MAGE study indicates that Gla-300, as part of a basal-bolus regimen, results in improved treatment satisfaction and reduced hypoglycemia fear in people with advanced T2DM.</description><identifier>ISSN: 1869-6953</identifier><identifier>ISSN: 1869-6961</identifier><identifier>EISSN: 1869-6961</identifier><identifier>DOI: 10.1007/s13300-020-00866-2</identifier><identifier>PMID: 32643130</identifier><language>eng</language><publisher>Cheshire: Springer Healthcare</publisher><subject>Basal-bolus insulin regimen ; Cardiology ; Diabetes ; Drug therapy ; Endocrinologie, métabolisme &amp; nutrition ; Endocrinology ; Endocrinology, metabolism &amp; nutrition ; Human health sciences ; Hyperglycemia ; Hypoglycemia ; Insulin ; Insulin glargine 300 U/mL ; Internal Medicine ; Medicine ; Medicine &amp; Public Health ; Observational studies ; Original Research ; Pharmacie, pharmacologie &amp; toxicologie ; Pharmacy, pharmacology &amp; toxicology ; Quality of life ; Sciences de la santé humaine ; Type 2 diabetes</subject><ispartof>Diabetes therapy, 2020-08, Vol.11 (8), p.1835-1847</ispartof><rights>The Author(s) 2020</rights><rights>The Author(s) 2020. 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-c495t-f6bf50e1ae3ba47b95a9dc91bbd1854a87df1d94c0ac412d6db109649852cbaa3</citedby><cites>FETCH-LOGICAL-c495t-f6bf50e1ae3ba47b95a9dc91bbd1854a87df1d94c0ac412d6db109649852cbaa3</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/PMC7376812/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC7376812/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,314,723,776,780,860,881,27901,27902,41096,42165,51551,53766,53768</link.rule.ids></links><search><creatorcontrib>Colin, Ides M.</creatorcontrib><creatorcontrib>Alexandre, Kathy</creatorcontrib><creatorcontrib>Bruhwyler, Jacques</creatorcontrib><creatorcontrib>Scheen, André</creatorcontrib><creatorcontrib>Verhaegen, Ann</creatorcontrib><title>Patient-Reported Outcomes with Insulin Glargine 300 U/mL in People with Type 2 Diabetes: The MAGE Multicenter Observational Study</title><title>Diabetes therapy</title><addtitle>Diabetes Ther</addtitle><description>Introduction MAGE was a Multicenter, single-Arm, observational 6-month (plus 6-month extension) study that aimed to assess treatment satisfaction, efficacy, and safety of insulin Glargine 300 U/mL (Gla-300) in people with type 2 diabetes (T2DM) receiving basal-bolus insulin in a rEal-world setting. Materials and methods Participants were at least 18 years old, with T2DM for more than 1 year, HbA 1c 7.0–10.0%. The primary endpoint was change in Diabetes Treatment Satisfaction Questionnaire status version (DTSQs) total score (baseline to month 6). Secondary endpoints included reasons for starting Gla-300, changes in the DTSQ change version (DTSQc) total score, Hypoglycemia Fear Survey-II (HFS-II) total behavior and worry scores at months 6 and 12, HbA 1c changes at months 3, 6, 9, and 12, and safety. Results MAGE included 87 adults (mean T2DM duration 17 years). The primary endpoint of DTSQs mean (standard deviation) total score improvement at month 6 was achieved (2.80 [5.46] points; p  &lt; 0.0001). The main reasons for Gla-300 initiation were to decrease HbA 1c (89.7% of participants) and reduce the number of hypoglycemic events (35.6% of participants). Significant improvements were observed in the DTSQc total score and perceived hyperglycemia/hypoglycemia (baseline to month 6, p  &lt; 0.05). Significant changes in HFS-II behavior, worry, and total scores at 6 and 12 months were also observed ( p  &lt; 0.05). There were no statistically significant changes in HbA 1c . Safety outcomes, including hypoglycemia, were comparable to previously reported trials. Conclusions The MAGE study indicates that Gla-300, as part of a basal-bolus regimen, results in improved treatment satisfaction and reduced hypoglycemia fear in people with advanced T2DM.</description><subject>Basal-bolus insulin regimen</subject><subject>Cardiology</subject><subject>Diabetes</subject><subject>Drug therapy</subject><subject>Endocrinologie, métabolisme &amp; nutrition</subject><subject>Endocrinology</subject><subject>Endocrinology, metabolism &amp; nutrition</subject><subject>Human health sciences</subject><subject>Hyperglycemia</subject><subject>Hypoglycemia</subject><subject>Insulin</subject><subject>Insulin glargine 300 U/mL</subject><subject>Internal Medicine</subject><subject>Medicine</subject><subject>Medicine &amp; Public Health</subject><subject>Observational studies</subject><subject>Original Research</subject><subject>Pharmacie, pharmacologie &amp; toxicologie</subject><subject>Pharmacy, pharmacology &amp; toxicology</subject><subject>Quality of life</subject><subject>Sciences de la santé humaine</subject><subject>Type 2 diabetes</subject><issn>1869-6953</issn><issn>1869-6961</issn><issn>1869-6961</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2020</creationdate><recordtype>article</recordtype><sourceid>C6C</sourceid><sourceid>BENPR</sourceid><recordid>eNp9ks1q3DAUhU1paUKaF-hK0E03bvRjy1YXhZCkk8CECe1kLST72qMgW65kT5l1XyTPkieLMg7pz6ICISF995wrcZLkPcGfCMbFSSCMYZxiGicuOU_pq-SQlFykXHDy-mWfs4PkOIQ7HAcTQhDyNjlglGeMMHyY_LpRo4F-TL_B4PwINVpNY-U6COinGTfoqg-TNT1aWOVb0wOKpg_3tyfdEsXTG3CDhZlc7wZ4uKfo3CgNI4TPaL0BdH26uEDXkx1NFV3Ao5UO4LfR1PXKou_jVO_eJW8aZQMcP69Hye3Xi_XZZbpcLa7OTpdplYl8TBuumxwDUcC0ygotciXqShCta1LmmSqLuiG1yCqsqozQmteaYMEzUea00kqxo-TLrDtMuoP6qSGvrBy86ZTfSaeM_PumNxvZuq0sWMFLQqMAmwWsgRak89rILd0X7veTbaWqpAZJKS8lzYRgeaz6-Gzr3Y8Jwig7EyqwVvXgphAxSjHOKC4i-uEf9M5NPn5UpPLYQMkxY5GiM1V5F4KH5uUJBMuncMg5HDKGQ-7DIf_oPUS4b8H_lv5P1SO8VLzq</recordid><startdate>20200801</startdate><enddate>20200801</enddate><creator>Colin, Ides M.</creator><creator>Alexandre, Kathy</creator><creator>Bruhwyler, Jacques</creator><creator>Scheen, André</creator><creator>Verhaegen, Ann</creator><general>Springer Healthcare</general><general>Springer Nature B.V</general><scope>C6C</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>PHGZM</scope><scope>PHGZT</scope><scope>PIMPY</scope><scope>PJZUB</scope><scope>PKEHL</scope><scope>PPXIY</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>7X8</scope><scope>Q33</scope><scope>5PM</scope></search><sort><creationdate>20200801</creationdate><title>Patient-Reported Outcomes with Insulin Glargine 300 U/mL in People with Type 2 Diabetes: The MAGE Multicenter Observational Study</title><author>Colin, Ides M. ; Alexandre, Kathy ; Bruhwyler, Jacques ; Scheen, André ; Verhaegen, Ann</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c495t-f6bf50e1ae3ba47b95a9dc91bbd1854a87df1d94c0ac412d6db109649852cbaa3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2020</creationdate><topic>Basal-bolus insulin regimen</topic><topic>Cardiology</topic><topic>Diabetes</topic><topic>Drug therapy</topic><topic>Endocrinologie, métabolisme &amp; nutrition</topic><topic>Endocrinology</topic><topic>Endocrinology, metabolism &amp; nutrition</topic><topic>Human health sciences</topic><topic>Hyperglycemia</topic><topic>Hypoglycemia</topic><topic>Insulin</topic><topic>Insulin glargine 300 U/mL</topic><topic>Internal Medicine</topic><topic>Medicine</topic><topic>Medicine &amp; Public Health</topic><topic>Observational studies</topic><topic>Original Research</topic><topic>Pharmacie, pharmacologie &amp; toxicologie</topic><topic>Pharmacy, pharmacology &amp; toxicology</topic><topic>Quality of life</topic><topic>Sciences de la santé humaine</topic><topic>Type 2 diabetes</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Colin, Ides M.</creatorcontrib><creatorcontrib>Alexandre, Kathy</creatorcontrib><creatorcontrib>Bruhwyler, Jacques</creatorcontrib><creatorcontrib>Scheen, André</creatorcontrib><creatorcontrib>Verhaegen, Ann</creatorcontrib><collection>Springer Nature OA Free Journals</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Nursing &amp; Allied Health Database</collection><collection>Health &amp; 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 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>Consumer Health Database (Alumni Edition)</collection><collection>ProQuest Health &amp; Medical Complete (Alumni)</collection><collection>Nursing &amp; Allied Health Database (Alumni Edition)</collection><collection>Consumer Health Database</collection><collection>Health &amp; Medical Collection (Alumni Edition)</collection><collection>Nursing &amp; Allied Health Premium</collection><collection>ProQuest Central (New)</collection><collection>ProQuest One Academic (New)</collection><collection>Publicly Available Content Database</collection><collection>ProQuest Health &amp; Medical Research Collection</collection><collection>ProQuest One Academic Middle East (New)</collection><collection>ProQuest One Health &amp; Nursing</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>Université de Liège - Open Repository and Bibliography (ORBI)</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>Colin, Ides M.</au><au>Alexandre, Kathy</au><au>Bruhwyler, Jacques</au><au>Scheen, André</au><au>Verhaegen, Ann</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Patient-Reported Outcomes with Insulin Glargine 300 U/mL in People with Type 2 Diabetes: The MAGE Multicenter Observational Study</atitle><jtitle>Diabetes therapy</jtitle><stitle>Diabetes Ther</stitle><date>2020-08-01</date><risdate>2020</risdate><volume>11</volume><issue>8</issue><spage>1835</spage><epage>1847</epage><pages>1835-1847</pages><issn>1869-6953</issn><issn>1869-6961</issn><eissn>1869-6961</eissn><abstract>Introduction MAGE was a Multicenter, single-Arm, observational 6-month (plus 6-month extension) study that aimed to assess treatment satisfaction, efficacy, and safety of insulin Glargine 300 U/mL (Gla-300) in people with type 2 diabetes (T2DM) receiving basal-bolus insulin in a rEal-world setting. Materials and methods Participants were at least 18 years old, with T2DM for more than 1 year, HbA 1c 7.0–10.0%. The primary endpoint was change in Diabetes Treatment Satisfaction Questionnaire status version (DTSQs) total score (baseline to month 6). Secondary endpoints included reasons for starting Gla-300, changes in the DTSQ change version (DTSQc) total score, Hypoglycemia Fear Survey-II (HFS-II) total behavior and worry scores at months 6 and 12, HbA 1c changes at months 3, 6, 9, and 12, and safety. Results MAGE included 87 adults (mean T2DM duration 17 years). The primary endpoint of DTSQs mean (standard deviation) total score improvement at month 6 was achieved (2.80 [5.46] points; p  &lt; 0.0001). The main reasons for Gla-300 initiation were to decrease HbA 1c (89.7% of participants) and reduce the number of hypoglycemic events (35.6% of participants). Significant improvements were observed in the DTSQc total score and perceived hyperglycemia/hypoglycemia (baseline to month 6, p  &lt; 0.05). Significant changes in HFS-II behavior, worry, and total scores at 6 and 12 months were also observed ( p  &lt; 0.05). There were no statistically significant changes in HbA 1c . Safety outcomes, including hypoglycemia, were comparable to previously reported trials. Conclusions The MAGE study indicates that Gla-300, as part of a basal-bolus regimen, results in improved treatment satisfaction and reduced hypoglycemia fear in people with advanced T2DM.</abstract><cop>Cheshire</cop><pub>Springer Healthcare</pub><pmid>32643130</pmid><doi>10.1007/s13300-020-00866-2</doi><tpages>13</tpages><oa>free_for_read</oa></addata></record>
fulltext fulltext
identifier ISSN: 1869-6953
ispartof Diabetes therapy, 2020-08, Vol.11 (8), p.1835-1847
issn 1869-6953
1869-6961
1869-6961
language eng
recordid cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_7376812
source DOAJ Directory of Open Access Journals; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals; PubMed Central; Springer Nature OA Free Journals
subjects Basal-bolus insulin regimen
Cardiology
Diabetes
Drug therapy
Endocrinologie, métabolisme & nutrition
Endocrinology
Endocrinology, metabolism & nutrition
Human health sciences
Hyperglycemia
Hypoglycemia
Insulin
Insulin glargine 300 U/mL
Internal Medicine
Medicine
Medicine & Public Health
Observational studies
Original Research
Pharmacie, pharmacologie & toxicologie
Pharmacy, pharmacology & toxicology
Quality of life
Sciences de la santé humaine
Type 2 diabetes
title Patient-Reported Outcomes with Insulin Glargine 300 U/mL in People with Type 2 Diabetes: The MAGE Multicenter Observational Study
url https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-02-20T13%3A23%3A34IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_pubme&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Patient-Reported%20Outcomes%20with%20Insulin%20Glargine%20300%C2%A0U/mL%20in%20People%20with%20Type%C2%A02%20Diabetes:%20The%20MAGE%20Multicenter%20Observational%20Study&rft.jtitle=Diabetes%20therapy&rft.au=Colin,%20Ides%20M.&rft.date=2020-08-01&rft.volume=11&rft.issue=8&rft.spage=1835&rft.epage=1847&rft.pages=1835-1847&rft.issn=1869-6953&rft.eissn=1869-6961&rft_id=info:doi/10.1007/s13300-020-00866-2&rft_dat=%3Cproquest_pubme%3E2512386033%3C/proquest_pubme%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=2512386033&rft_id=info:pmid/32643130&rfr_iscdi=true