Once‐weekly insulin efsitora alfa: Design and rationale for the QWINT phase 3 clinical development programme
Aims Insulin efsitora alfa (efsitora) is a once‐weekly basal insulin. This review describes the study design and rationale of the efsitora phase 3 Once Weekly (QW) Insulin Therapy (QWINT) clinical development programme, including the five trials, QWINT‐1 through QWINT‐5. Materials and Methods The fi...
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| Veröffentlicht in: | Diabetes, obesity & metabolism obesity & metabolism, 2024-08, Vol.26 (8), p.3020-3030 |
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| container_title | Diabetes, obesity & metabolism |
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| creator | Bergenstal, Richard M. Philis‐Tsimikas, Athena Wysham, Carol Carr, Molly C. Bue‐Valleskey, Juliana M. Botros, Fady T. Blevins, Thomas Rosenstock, Julio |
| description | Aims
Insulin efsitora alfa (efsitora) is a once‐weekly basal insulin. This review describes the study design and rationale of the efsitora phase 3 Once Weekly (QW) Insulin Therapy (QWINT) clinical development programme, including the five trials, QWINT‐1 through QWINT‐5.
Materials and Methods
The five trials included insulin‐naïve adults (QWINT‐1 and ‐2) with type 2 diabetes (T2D), adults with T2D previously treated with basal insulin (QWINT‐3 and ‐4), and QWINT‐5 in adults with type 1 diabetes. All five trials were designed as multicentre, randomized, controlled, open‐label, treat‐to‐target studies to investigate the efficacy and safety of efsitora versus active once‐daily basal insulin comparators (insulin glargine U100 or insulin degludec U100). The primary objective of each trial is to compare the change in HbA1c from baseline to week 26 or 52 between efsitora and the active comparator. The key secondary objectives include change in fasting glucose, insulin dose and continuous glucose monitoring variables, and patient‐reported outcome questionnaires.
Conclusions
The QWINT development programme includes a racially and geographically diverse population to provide important information regarding the efficacy and safety of efsitora and its clinical management of people with diabetes. |
| doi_str_mv | 10.1111/dom.15604 |
| format | Article |
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Insulin efsitora alfa (efsitora) is a once‐weekly basal insulin. This review describes the study design and rationale of the efsitora phase 3 Once Weekly (QW) Insulin Therapy (QWINT) clinical development programme, including the five trials, QWINT‐1 through QWINT‐5.
Materials and Methods
The five trials included insulin‐naïve adults (QWINT‐1 and ‐2) with type 2 diabetes (T2D), adults with T2D previously treated with basal insulin (QWINT‐3 and ‐4), and QWINT‐5 in adults with type 1 diabetes. All five trials were designed as multicentre, randomized, controlled, open‐label, treat‐to‐target studies to investigate the efficacy and safety of efsitora versus active once‐daily basal insulin comparators (insulin glargine U100 or insulin degludec U100). The primary objective of each trial is to compare the change in HbA1c from baseline to week 26 or 52 between efsitora and the active comparator. The key secondary objectives include change in fasting glucose, insulin dose and continuous glucose monitoring variables, and patient‐reported outcome questionnaires.
Conclusions
The QWINT development programme includes a racially and geographically diverse population to provide important information regarding the efficacy and safety of efsitora and its clinical management of people with diabetes.</description><identifier>ISSN: 1462-8902</identifier><identifier>ISSN: 1463-1326</identifier><identifier>EISSN: 1463-1326</identifier><identifier>DOI: 10.1111/dom.15604</identifier><identifier>PMID: 38679838</identifier><language>eng</language><publisher>Oxford, UK: Blackwell Publishing Ltd</publisher><subject>basal insulin ; clinical trial ; Clinical trials ; Diabetes ; Diabetes mellitus (insulin dependent) ; Diabetes mellitus (non-insulin dependent) ; Disease management ; Glucose monitoring ; Insulin ; type 1 diabetes ; type 2 diabetes</subject><ispartof>Diabetes, obesity & metabolism, 2024-08, Vol.26 (8), p.3020-3030</ispartof><rights>2024 The Authors. published by John Wiley & Sons Ltd.</rights><rights>2024 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd.</rights><rights>2024. This article is published under http://creativecommons.org/licenses/by-nc-nd/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-c3884-bbce7d62c22a462929565ab32bd911e74ff8d9642133c352383042b6921608433</citedby><cites>FETCH-LOGICAL-c3884-bbce7d62c22a462929565ab32bd911e74ff8d9642133c352383042b6921608433</cites><orcidid>0000-0002-9746-7744 ; 0000-0001-8324-3275 ; 0000-0002-9050-5584 ; 0000-0003-3746-9606 ; 0000-0002-3056-0047 ; 0000-0003-1980-4458</orcidid></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.15604$$EPDF$$P50$$Gwiley$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1111%2Fdom.15604$$EHTML$$P50$$Gwiley$$Hfree_for_read</linktohtml><link.rule.ids>314,776,780,1411,27901,27902,45550,45551</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/38679838$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Bergenstal, Richard M.</creatorcontrib><creatorcontrib>Philis‐Tsimikas, Athena</creatorcontrib><creatorcontrib>Wysham, Carol</creatorcontrib><creatorcontrib>Carr, Molly C.</creatorcontrib><creatorcontrib>Bue‐Valleskey, Juliana M.</creatorcontrib><creatorcontrib>Botros, Fady T.</creatorcontrib><creatorcontrib>Blevins, Thomas</creatorcontrib><creatorcontrib>Rosenstock, Julio</creatorcontrib><title>Once‐weekly insulin efsitora alfa: Design and rationale for the QWINT phase 3 clinical development programme</title><title>Diabetes, obesity & metabolism</title><addtitle>Diabetes Obes Metab</addtitle><description>Aims
Insulin efsitora alfa (efsitora) is a once‐weekly basal insulin. This review describes the study design and rationale of the efsitora phase 3 Once Weekly (QW) Insulin Therapy (QWINT) clinical development programme, including the five trials, QWINT‐1 through QWINT‐5.
Materials and Methods
The five trials included insulin‐naïve adults (QWINT‐1 and ‐2) with type 2 diabetes (T2D), adults with T2D previously treated with basal insulin (QWINT‐3 and ‐4), and QWINT‐5 in adults with type 1 diabetes. All five trials were designed as multicentre, randomized, controlled, open‐label, treat‐to‐target studies to investigate the efficacy and safety of efsitora versus active once‐daily basal insulin comparators (insulin glargine U100 or insulin degludec U100). The primary objective of each trial is to compare the change in HbA1c from baseline to week 26 or 52 between efsitora and the active comparator. The key secondary objectives include change in fasting glucose, insulin dose and continuous glucose monitoring variables, and patient‐reported outcome questionnaires.
Conclusions
The QWINT development programme includes a racially and geographically diverse population to provide important information regarding the efficacy and safety of efsitora and its clinical management of people with diabetes.</description><subject>basal insulin</subject><subject>clinical trial</subject><subject>Clinical trials</subject><subject>Diabetes</subject><subject>Diabetes mellitus (insulin dependent)</subject><subject>Diabetes mellitus (non-insulin dependent)</subject><subject>Disease management</subject><subject>Glucose monitoring</subject><subject>Insulin</subject><subject>type 1 diabetes</subject><subject>type 2 diabetes</subject><issn>1462-8902</issn><issn>1463-1326</issn><issn>1463-1326</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2024</creationdate><recordtype>article</recordtype><sourceid>24P</sourceid><recordid>eNp10U1PFDEYB_DGYORFD34B0oSLHAb6tp3WG1lQN1ndmGA8TjqdZ6DQaZd2RrI3PoKf0U9iYdGDib20h1__zdM_Qm8pOaFlnXZxOKEzScQLtEeF5BXlTO48nVmlNGG7aD_nG0KI4Kp-hXa5krVWXO2hsAoWfj38vAe49RvsQp68Cxj67MaYDDa-N-_xOWR3FbAJHU5mdDEYD7iPCY_XgL9-X3y5xOtrkwFzbMt1Z43HHfwAH9cDhBGvU7xKZhjgNXrZG5_hzfN-gL59uLicf6qWq4-L-dmyslwpUbWthbqTzDJmygya6ZmcmZazttOUQi36XnVaCkY5t3zGuOJEsFZqRiVRgvMD9G6bW16-myCPzeCyBe9NgDjlpnAlNJdSF3r0D72JUyoTPqq6AKIkKep4q2yKOSfom3Vyg0mbhpLmsYSmlNA8lVDs4XPi1A7Q_ZV_fr2A0y24dx42_09qzleft5G_AVsUj9M</recordid><startdate>202408</startdate><enddate>202408</enddate><creator>Bergenstal, Richard M.</creator><creator>Philis‐Tsimikas, Athena</creator><creator>Wysham, Carol</creator><creator>Carr, Molly C.</creator><creator>Bue‐Valleskey, Juliana M.</creator><creator>Botros, Fady T.</creator><creator>Blevins, Thomas</creator><creator>Rosenstock, Julio</creator><general>Blackwell Publishing Ltd</general><general>Wiley Subscription Services, Inc</general><scope>24P</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7T5</scope><scope>7TK</scope><scope>H94</scope><scope>K9.</scope><scope>7X8</scope><orcidid>https://orcid.org/0000-0002-9746-7744</orcidid><orcidid>https://orcid.org/0000-0001-8324-3275</orcidid><orcidid>https://orcid.org/0000-0002-9050-5584</orcidid><orcidid>https://orcid.org/0000-0003-3746-9606</orcidid><orcidid>https://orcid.org/0000-0002-3056-0047</orcidid><orcidid>https://orcid.org/0000-0003-1980-4458</orcidid></search><sort><creationdate>202408</creationdate><title>Once‐weekly insulin efsitora alfa: Design and rationale for the QWINT phase 3 clinical development programme</title><author>Bergenstal, Richard M. ; Philis‐Tsimikas, Athena ; Wysham, Carol ; Carr, Molly C. ; Bue‐Valleskey, Juliana M. ; Botros, Fady T. ; Blevins, Thomas ; Rosenstock, Julio</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c3884-bbce7d62c22a462929565ab32bd911e74ff8d9642133c352383042b6921608433</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2024</creationdate><topic>basal insulin</topic><topic>clinical trial</topic><topic>Clinical trials</topic><topic>Diabetes</topic><topic>Diabetes mellitus (insulin dependent)</topic><topic>Diabetes mellitus (non-insulin dependent)</topic><topic>Disease management</topic><topic>Glucose monitoring</topic><topic>Insulin</topic><topic>type 1 diabetes</topic><topic>type 2 diabetes</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Bergenstal, Richard M.</creatorcontrib><creatorcontrib>Philis‐Tsimikas, Athena</creatorcontrib><creatorcontrib>Wysham, Carol</creatorcontrib><creatorcontrib>Carr, Molly C.</creatorcontrib><creatorcontrib>Bue‐Valleskey, Juliana M.</creatorcontrib><creatorcontrib>Botros, Fady T.</creatorcontrib><creatorcontrib>Blevins, Thomas</creatorcontrib><creatorcontrib>Rosenstock, Julio</creatorcontrib><collection>Wiley Online Library Open Access</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>MEDLINE - Academic</collection><jtitle>Diabetes, obesity & metabolism</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Bergenstal, Richard M.</au><au>Philis‐Tsimikas, Athena</au><au>Wysham, Carol</au><au>Carr, Molly C.</au><au>Bue‐Valleskey, Juliana M.</au><au>Botros, Fady T.</au><au>Blevins, Thomas</au><au>Rosenstock, Julio</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Once‐weekly insulin efsitora alfa: Design and rationale for the QWINT phase 3 clinical development programme</atitle><jtitle>Diabetes, obesity & metabolism</jtitle><addtitle>Diabetes Obes Metab</addtitle><date>2024-08</date><risdate>2024</risdate><volume>26</volume><issue>8</issue><spage>3020</spage><epage>3030</epage><pages>3020-3030</pages><issn>1462-8902</issn><issn>1463-1326</issn><eissn>1463-1326</eissn><abstract>Aims
Insulin efsitora alfa (efsitora) is a once‐weekly basal insulin. This review describes the study design and rationale of the efsitora phase 3 Once Weekly (QW) Insulin Therapy (QWINT) clinical development programme, including the five trials, QWINT‐1 through QWINT‐5.
Materials and Methods
The five trials included insulin‐naïve adults (QWINT‐1 and ‐2) with type 2 diabetes (T2D), adults with T2D previously treated with basal insulin (QWINT‐3 and ‐4), and QWINT‐5 in adults with type 1 diabetes. All five trials were designed as multicentre, randomized, controlled, open‐label, treat‐to‐target studies to investigate the efficacy and safety of efsitora versus active once‐daily basal insulin comparators (insulin glargine U100 or insulin degludec U100). The primary objective of each trial is to compare the change in HbA1c from baseline to week 26 or 52 between efsitora and the active comparator. The key secondary objectives include change in fasting glucose, insulin dose and continuous glucose monitoring variables, and patient‐reported outcome questionnaires.
Conclusions
The QWINT development programme includes a racially and geographically diverse population to provide important information regarding the efficacy and safety of efsitora and its clinical management of people with diabetes.</abstract><cop>Oxford, UK</cop><pub>Blackwell Publishing Ltd</pub><pmid>38679838</pmid><doi>10.1111/dom.15604</doi><tpages>11</tpages><orcidid>https://orcid.org/0000-0002-9746-7744</orcidid><orcidid>https://orcid.org/0000-0001-8324-3275</orcidid><orcidid>https://orcid.org/0000-0002-9050-5584</orcidid><orcidid>https://orcid.org/0000-0003-3746-9606</orcidid><orcidid>https://orcid.org/0000-0002-3056-0047</orcidid><orcidid>https://orcid.org/0000-0003-1980-4458</orcidid><oa>free_for_read</oa></addata></record> |
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| source | Wiley Online Library Journals Frontfile Complete |
| subjects | basal insulin clinical trial Clinical trials Diabetes Diabetes mellitus (insulin dependent) Diabetes mellitus (non-insulin dependent) Disease management Glucose monitoring Insulin type 1 diabetes type 2 diabetes |
| title | Once‐weekly insulin efsitora alfa: Design and rationale for the QWINT phase 3 clinical development programme |
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