Take Control: A randomized trial evaluating the efficacy and safety of self‐ versus physician‐managed titration of insulin glargine 300 U/mL in patients with uncontrolled type 2 diabetes
Aim To compare the efficacy and safety of self‐ versus physician‐managed titration of insulin glargine 300 U/mL (Gla‐300) in people with inadequately controlled type 2 diabetes. Methods Take Control (EudraCT number: 2015‐001626‐42) was a 24‐week, multi‐national, open‐label, controlled, two‐arm, para...
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| Veröffentlicht in: | Diabetes, obesity & metabolism obesity & metabolism, 2019-07, Vol.21 (7), p.1615-1624 |
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| creator | Russell‐Jones, David Dauchy, Arnaud Delgado, Elías Dimitriadis, George Frandsen, Hans A. Popescu, Luiza Schultes, Bernd Strojek, Krzysztof Bonnemaire, Mireille Roborel de Climens, Aude Davies, Melanie |
| description | Aim
To compare the efficacy and safety of self‐ versus physician‐managed titration of insulin glargine 300 U/mL (Gla‐300) in people with inadequately controlled type 2 diabetes.
Methods
Take Control (EudraCT number: 2015‐001626‐42) was a 24‐week, multi‐national, open‐label, controlled, two‐arm, parallel‐group study in insulin‐naïve and pre‐treated participants, randomized 1:1 to a self‐ or physician‐managed titration of Gla‐300. The fasting self‐monitored plasma glucose (SMPG) target was 4.4 to 7.2 mmol/L. The primary outcome was non‐inferiority of glycated haemoglobin (HbA1c) change from baseline to week 24. Secondary outcomes included SMPG target achievement without hypoglycaemia, hypoglycaemia incidence, adverse events and participant‐reported outcomes (PROs).
Results
At week 24, the least squares (LS) mean HbA1c reduction was 0.97% (10.6 mmol/mol) and 0.84% (9.2 mmol/mol) in the self‐ and physician‐managed groups, respectively, with an LS mean difference of −0.13% [95% confidence interval −0.2619 to −0.0004] (–1.4 mmol/mol [–2.863 to –0.004]), demonstrating non‐inferiority (P |
| doi_str_mv | 10.1111/dom.13697 |
| format | Article |
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To compare the efficacy and safety of self‐ versus physician‐managed titration of insulin glargine 300 U/mL (Gla‐300) in people with inadequately controlled type 2 diabetes.
Methods
Take Control (EudraCT number: 2015‐001626‐42) was a 24‐week, multi‐national, open‐label, controlled, two‐arm, parallel‐group study in insulin‐naïve and pre‐treated participants, randomized 1:1 to a self‐ or physician‐managed titration of Gla‐300. The fasting self‐monitored plasma glucose (SMPG) target was 4.4 to 7.2 mmol/L. The primary outcome was non‐inferiority of glycated haemoglobin (HbA1c) change from baseline to week 24. Secondary outcomes included SMPG target achievement without hypoglycaemia, hypoglycaemia incidence, adverse events and participant‐reported outcomes (PROs).
Results
At week 24, the least squares (LS) mean HbA1c reduction was 0.97% (10.6 mmol/mol) and 0.84% (9.2 mmol/mol) in the self‐ and physician‐managed groups, respectively, with an LS mean difference of −0.13% [95% confidence interval −0.2619 to −0.0004] (–1.4 mmol/mol [–2.863 to –0.004]), demonstrating non‐inferiority (P < 0.0001) and superiority (P = 0.0247) of self‐ versus physician‐managed titration. Significantly more of the self‐ than physician‐managed group achieved SMPG target without hypoglycaemia (67% vs 58%; P = 0.0187). Overall, hypoglycaemia incidence was similar in each group. No safety concerns were reported. In both groups, similar PRO improvements were observed for distress related to diabetes disease burden and for confidence in diabetes self‐management, with even more individuals achieving a clinically relevant reduction in emotional burden and fewer individuals with high emotional burden in the self‐managed group.
Conclusions
Self‐managed titration of Gla‐300 was superior to physician‐managed titration in terms of HbA1c reduction, accompanied by similar total PRO scores, with a clinically relevant reduction in emotional burden, and similar hypoglycaemia frequency.</description><identifier>ISSN: 1462-8902</identifier><identifier>ISSN: 1463-1326</identifier><identifier>EISSN: 1463-1326</identifier><identifier>DOI: 10.1111/dom.13697</identifier><identifier>PMID: 30851006</identifier><language>eng</language><publisher>Oxford, UK: Blackwell Publishing Ltd</publisher><subject>Aged ; Blood Glucose - analysis ; Diabetes Mellitus, Type 2 - drug therapy ; Female ; glycaemic control ; Glycated Hemoglobin - analysis ; Humans ; hypoglycaemia ; Hypoglycemia - chemically induced ; Hypoglycemia - epidemiology ; Hypoglycemic Agents - administration & dosage ; Hypoglycemic Agents - adverse effects ; Hypoglycemic Agents - therapeutic use ; Insulin Glargine - administration & dosage ; Insulin Glargine - adverse effects ; Insulin Glargine - therapeutic use ; Male ; Middle Aged ; Original ; randomized trial ; Self-Management ; type 2 diabetes</subject><ispartof>Diabetes, obesity & metabolism, 2019-07, Vol.21 (7), p.1615-1624</ispartof><rights>2019 John Wiley & Sons Ltd</rights><rights>2019 John Wiley & Sons Ltd.</rights><rights>2019 The Authors. published by John Wiley & Sons Ltd.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c4157-d27cc64a269b18fa84c2144bc570cefc53113ac2630561bdfda8bcadf83355fc3</citedby><cites>FETCH-LOGICAL-c4157-d27cc64a269b18fa84c2144bc570cefc53113ac2630561bdfda8bcadf83355fc3</cites><orcidid>0000-0002-9987-9371 ; 0000-0002-9490-2480</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.13697$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1111%2Fdom.13697$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>230,314,776,780,881,1411,27903,27904,45553,45554</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/30851006$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Russell‐Jones, David</creatorcontrib><creatorcontrib>Dauchy, Arnaud</creatorcontrib><creatorcontrib>Delgado, Elías</creatorcontrib><creatorcontrib>Dimitriadis, George</creatorcontrib><creatorcontrib>Frandsen, Hans A.</creatorcontrib><creatorcontrib>Popescu, Luiza</creatorcontrib><creatorcontrib>Schultes, Bernd</creatorcontrib><creatorcontrib>Strojek, Krzysztof</creatorcontrib><creatorcontrib>Bonnemaire, Mireille</creatorcontrib><creatorcontrib>Roborel de Climens, Aude</creatorcontrib><creatorcontrib>Davies, Melanie</creatorcontrib><title>Take Control: A randomized trial evaluating the efficacy and safety of self‐ versus physician‐managed titration of insulin glargine 300 U/mL in patients with uncontrolled type 2 diabetes</title><title>Diabetes, obesity & metabolism</title><addtitle>Diabetes Obes Metab</addtitle><description>Aim
To compare the efficacy and safety of self‐ versus physician‐managed titration of insulin glargine 300 U/mL (Gla‐300) in people with inadequately controlled type 2 diabetes.
Methods
Take Control (EudraCT number: 2015‐001626‐42) was a 24‐week, multi‐national, open‐label, controlled, two‐arm, parallel‐group study in insulin‐naïve and pre‐treated participants, randomized 1:1 to a self‐ or physician‐managed titration of Gla‐300. The fasting self‐monitored plasma glucose (SMPG) target was 4.4 to 7.2 mmol/L. The primary outcome was non‐inferiority of glycated haemoglobin (HbA1c) change from baseline to week 24. Secondary outcomes included SMPG target achievement without hypoglycaemia, hypoglycaemia incidence, adverse events and participant‐reported outcomes (PROs).
Results
At week 24, the least squares (LS) mean HbA1c reduction was 0.97% (10.6 mmol/mol) and 0.84% (9.2 mmol/mol) in the self‐ and physician‐managed groups, respectively, with an LS mean difference of −0.13% [95% confidence interval −0.2619 to −0.0004] (–1.4 mmol/mol [–2.863 to –0.004]), demonstrating non‐inferiority (P < 0.0001) and superiority (P = 0.0247) of self‐ versus physician‐managed titration. Significantly more of the self‐ than physician‐managed group achieved SMPG target without hypoglycaemia (67% vs 58%; P = 0.0187). Overall, hypoglycaemia incidence was similar in each group. No safety concerns were reported. In both groups, similar PRO improvements were observed for distress related to diabetes disease burden and for confidence in diabetes self‐management, with even more individuals achieving a clinically relevant reduction in emotional burden and fewer individuals with high emotional burden in the self‐managed group.
Conclusions
Self‐managed titration of Gla‐300 was superior to physician‐managed titration in terms of HbA1c reduction, accompanied by similar total PRO scores, with a clinically relevant reduction in emotional burden, and similar hypoglycaemia frequency.</description><subject>Aged</subject><subject>Blood Glucose - analysis</subject><subject>Diabetes Mellitus, Type 2 - drug therapy</subject><subject>Female</subject><subject>glycaemic control</subject><subject>Glycated Hemoglobin - analysis</subject><subject>Humans</subject><subject>hypoglycaemia</subject><subject>Hypoglycemia - chemically induced</subject><subject>Hypoglycemia - epidemiology</subject><subject>Hypoglycemic Agents - administration & dosage</subject><subject>Hypoglycemic Agents - adverse effects</subject><subject>Hypoglycemic Agents - therapeutic use</subject><subject>Insulin Glargine - administration & dosage</subject><subject>Insulin Glargine - adverse effects</subject><subject>Insulin Glargine - therapeutic use</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Original</subject><subject>randomized trial</subject><subject>Self-Management</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>2019</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp1kc1u1DAURiMEoqWw4AWQl7BIx44TJ8MCqRp-pUHdtGvrxrnOGBwn2MlUYdUtOx6JZ-mT4GlKBQu8seV7dO4nfUnynNFTFs-q6btTxsW6fJAcs1zwlPFMPLx9Z2m1ptlR8iSEL5TSnFfl4-SI06pglIrj5NcFfEWy6d3oe_uanBEPLurMd2zI6A1YgnuwE4zGtWTcIUGtjQI1k8iRABrHmfSaBLT65von2aMPUyDDbg5GGXDxrwMH7UFnRh89vTvwxoXJGkdaC741Dgmn9Ob6x-Wq28YZGSKIbgzkyow7Mjm1BLQHzTwgyUhjoMYRw9PkkQYb8NndfZJcvn93sfmYbs8_fNqcbVOVs6JMm6xUSuSQiXXNKg1VrjKW57UqSqpQq4IzxkFlgtNCsLrRDVS1gkZXnBeFVvwkebN4h6nusFExnQcrB2868LPswch_J87sZNvvpShFmTMeBS_vBL7_NmEYZWeCQmvBYT8FmbFqXeSZKEREXy2o8n0IHvX9GkbloXEZK5K3jUf2xd-57sk_FUdgtQBXxuL8f5N8e_55Uf4G4Ve9tg</recordid><startdate>201907</startdate><enddate>201907</enddate><creator>Russell‐Jones, David</creator><creator>Dauchy, Arnaud</creator><creator>Delgado, Elías</creator><creator>Dimitriadis, George</creator><creator>Frandsen, Hans A.</creator><creator>Popescu, Luiza</creator><creator>Schultes, Bernd</creator><creator>Strojek, Krzysztof</creator><creator>Bonnemaire, Mireille</creator><creator>Roborel de Climens, Aude</creator><creator>Davies, Melanie</creator><general>Blackwell Publishing Ltd</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope><scope>5PM</scope><orcidid>https://orcid.org/0000-0002-9987-9371</orcidid><orcidid>https://orcid.org/0000-0002-9490-2480</orcidid></search><sort><creationdate>201907</creationdate><title>Take Control: A randomized trial evaluating the efficacy and safety of self‐ versus physician‐managed titration of insulin glargine 300 U/mL in patients with uncontrolled type 2 diabetes</title><author>Russell‐Jones, David ; Dauchy, Arnaud ; Delgado, Elías ; Dimitriadis, George ; Frandsen, Hans A. ; Popescu, Luiza ; Schultes, Bernd ; Strojek, Krzysztof ; Bonnemaire, Mireille ; Roborel de Climens, Aude ; Davies, Melanie</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c4157-d27cc64a269b18fa84c2144bc570cefc53113ac2630561bdfda8bcadf83355fc3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2019</creationdate><topic>Aged</topic><topic>Blood Glucose - analysis</topic><topic>Diabetes Mellitus, Type 2 - drug therapy</topic><topic>Female</topic><topic>glycaemic control</topic><topic>Glycated Hemoglobin - analysis</topic><topic>Humans</topic><topic>hypoglycaemia</topic><topic>Hypoglycemia - chemically induced</topic><topic>Hypoglycemia - epidemiology</topic><topic>Hypoglycemic Agents - administration & dosage</topic><topic>Hypoglycemic Agents - adverse effects</topic><topic>Hypoglycemic Agents - therapeutic use</topic><topic>Insulin Glargine - administration & dosage</topic><topic>Insulin Glargine - adverse effects</topic><topic>Insulin Glargine - therapeutic use</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Original</topic><topic>randomized trial</topic><topic>Self-Management</topic><topic>type 2 diabetes</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Russell‐Jones, David</creatorcontrib><creatorcontrib>Dauchy, Arnaud</creatorcontrib><creatorcontrib>Delgado, Elías</creatorcontrib><creatorcontrib>Dimitriadis, George</creatorcontrib><creatorcontrib>Frandsen, Hans A.</creatorcontrib><creatorcontrib>Popescu, Luiza</creatorcontrib><creatorcontrib>Schultes, Bernd</creatorcontrib><creatorcontrib>Strojek, Krzysztof</creatorcontrib><creatorcontrib>Bonnemaire, Mireille</creatorcontrib><creatorcontrib>Roborel de Climens, Aude</creatorcontrib><creatorcontrib>Davies, Melanie</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Diabetes, obesity & metabolism</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Russell‐Jones, David</au><au>Dauchy, Arnaud</au><au>Delgado, Elías</au><au>Dimitriadis, George</au><au>Frandsen, Hans A.</au><au>Popescu, Luiza</au><au>Schultes, Bernd</au><au>Strojek, Krzysztof</au><au>Bonnemaire, Mireille</au><au>Roborel de Climens, Aude</au><au>Davies, Melanie</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Take Control: A randomized trial evaluating the efficacy and safety of self‐ versus physician‐managed titration of insulin glargine 300 U/mL in patients with uncontrolled type 2 diabetes</atitle><jtitle>Diabetes, obesity & metabolism</jtitle><addtitle>Diabetes Obes Metab</addtitle><date>2019-07</date><risdate>2019</risdate><volume>21</volume><issue>7</issue><spage>1615</spage><epage>1624</epage><pages>1615-1624</pages><issn>1462-8902</issn><issn>1463-1326</issn><eissn>1463-1326</eissn><abstract>Aim
To compare the efficacy and safety of self‐ versus physician‐managed titration of insulin glargine 300 U/mL (Gla‐300) in people with inadequately controlled type 2 diabetes.
Methods
Take Control (EudraCT number: 2015‐001626‐42) was a 24‐week, multi‐national, open‐label, controlled, two‐arm, parallel‐group study in insulin‐naïve and pre‐treated participants, randomized 1:1 to a self‐ or physician‐managed titration of Gla‐300. The fasting self‐monitored plasma glucose (SMPG) target was 4.4 to 7.2 mmol/L. The primary outcome was non‐inferiority of glycated haemoglobin (HbA1c) change from baseline to week 24. Secondary outcomes included SMPG target achievement without hypoglycaemia, hypoglycaemia incidence, adverse events and participant‐reported outcomes (PROs).
Results
At week 24, the least squares (LS) mean HbA1c reduction was 0.97% (10.6 mmol/mol) and 0.84% (9.2 mmol/mol) in the self‐ and physician‐managed groups, respectively, with an LS mean difference of −0.13% [95% confidence interval −0.2619 to −0.0004] (–1.4 mmol/mol [–2.863 to –0.004]), demonstrating non‐inferiority (P < 0.0001) and superiority (P = 0.0247) of self‐ versus physician‐managed titration. Significantly more of the self‐ than physician‐managed group achieved SMPG target without hypoglycaemia (67% vs 58%; P = 0.0187). Overall, hypoglycaemia incidence was similar in each group. No safety concerns were reported. In both groups, similar PRO improvements were observed for distress related to diabetes disease burden and for confidence in diabetes self‐management, with even more individuals achieving a clinically relevant reduction in emotional burden and fewer individuals with high emotional burden in the self‐managed group.
Conclusions
Self‐managed titration of Gla‐300 was superior to physician‐managed titration in terms of HbA1c reduction, accompanied by similar total PRO scores, with a clinically relevant reduction in emotional burden, and similar hypoglycaemia frequency.</abstract><cop>Oxford, UK</cop><pub>Blackwell Publishing Ltd</pub><pmid>30851006</pmid><doi>10.1111/dom.13697</doi><tpages>10</tpages><orcidid>https://orcid.org/0000-0002-9987-9371</orcidid><orcidid>https://orcid.org/0000-0002-9490-2480</orcidid><oa>free_for_read</oa></addata></record> |
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| source | MEDLINE; Wiley Online Library Journals Frontfile Complete |
| subjects | Aged Blood Glucose - analysis Diabetes Mellitus, Type 2 - drug therapy Female glycaemic control Glycated Hemoglobin - analysis Humans hypoglycaemia Hypoglycemia - chemically induced Hypoglycemia - epidemiology Hypoglycemic Agents - administration & dosage Hypoglycemic Agents - adverse effects Hypoglycemic Agents - therapeutic use Insulin Glargine - administration & dosage Insulin Glargine - adverse effects Insulin Glargine - therapeutic use Male Middle Aged Original randomized trial Self-Management type 2 diabetes |
| title | Take Control: A randomized trial evaluating the efficacy and safety of self‐ versus physician‐managed titration of insulin glargine 300 U/mL in patients with uncontrolled type 2 diabetes |
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