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....
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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
< 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
< 0.05). Significant changes in HFS-II behavior, worry, and total scores at 6 and 12 months were also observed (
p
< 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 & 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</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
< 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
< 0.05). Significant changes in HFS-II behavior, worry, and total scores at 6 and 12 months were also observed (
p
< 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 & nutrition</subject><subject>Endocrinology</subject><subject>Endocrinology, metabolism & 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 & Public Health</subject><subject>Observational studies</subject><subject>Original Research</subject><subject>Pharmacie, pharmacologie & toxicologie</subject><subject>Pharmacy, pharmacology & 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 & nutrition</topic><topic>Endocrinology</topic><topic>Endocrinology, metabolism & 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 & Public Health</topic><topic>Observational studies</topic><topic>Original Research</topic><topic>Pharmacie, pharmacologie & toxicologie</topic><topic>Pharmacy, pharmacology & 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 & 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 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 & 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>ProQuest Central (New)</collection><collection>ProQuest One Academic (New)</collection><collection>Publicly Available Content Database</collection><collection>ProQuest Health & Medical Research Collection</collection><collection>ProQuest One Academic Middle East (New)</collection><collection>ProQuest One Health & 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
< 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
< 0.05). Significant changes in HFS-II behavior, worry, and total scores at 6 and 12 months were also observed (
p
< 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> |
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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 |
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