Sequential intensification of metformin treatment in type 2 diabetes with liraglutide followed by randomized addition of basal insulin prompted by A1C targets
We evaluated the addition of liraglutide to metformin in type 2 diabetes followed by intensification with basal insulin (detemir) if glycated hemoglobin (A1C) ≥7%. In 988 participants from North America and Europe uncontrolled on metformin ± sulfonylurea, sulfonylurea was discontinued and liraglutid...
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| Veröffentlicht in: | Diabetes care 2012-07, Vol.35 (7), p.1446-1454 |
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| creator | DeVries, J Hans Bain, Stephen C Rodbard, Helena W Seufert, Jochen D'Alessio, David Thomsen, Anne B Zychma, Marcin Rosenstock, Julio |
| description | We evaluated the addition of liraglutide to metformin in type 2 diabetes followed by intensification with basal insulin (detemir) if glycated hemoglobin (A1C) ≥7%.
In 988 participants from North America and Europe uncontrolled on metformin ± sulfonylurea, sulfonylurea was discontinued and liraglutide 1.8 mg/day added for 12 weeks (run-in). Subsequently, those with A1C ≥7% were randomized 1:1 to 26 weeks' open-label addition of insulin detemir to metformin + liraglutide (n = 162) or continuation without insulin detemir (n = 161). Patients achieving A1C |
| doi_str_mv | 10.2337/dc11-1928 |
| format | Article |
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In 988 participants from North America and Europe uncontrolled on metformin ± sulfonylurea, sulfonylurea was discontinued and liraglutide 1.8 mg/day added for 12 weeks (run-in). Subsequently, those with A1C ≥7% were randomized 1:1 to 26 weeks' open-label addition of insulin detemir to metformin + liraglutide (n = 162) or continuation without insulin detemir (n = 161). Patients achieving A1C <7% continued unchanged treatment (observational arm). The primary end point was A1C change between randomized groups.
Of 821 participants completing the run-in, 61% (n = 498) achieved A1C <7% (mean change -1.3% from 7.7% at start), whereas 39% (n = 323) did not (-0.6% from 8.3% at start). During run-in, 167 of 988 (17%) withdrew; 46% of these due to gastrointestinal adverse events. At week 26, A1C decreased further, by 0.5% (from 7.6% at randomization) with insulin detemir (n = 162) versus 0.02% increase without insulin detemir (n = 157) to 7.1 and 7.5%, respectively (estimated treatment difference -0.52 [95% CI -0.68 to -0.36]; P < 0.0001). Forty-three percent of participants with insulin detemir versus 17% without reached A1C <7%. Mean weight decreased by 3.5 kg during run-in, then by 0.16 kg with insulin detemir or 0.95 kg without insulin detemir. In the randomized phase, no major hypoglycemia occurred and minor hypoglycemia rates were 0.286 and 0.029 events per participant-year with and without insulin detemir (9.2 vs. 1.3%).
Supplementation of metformin with liraglutide and then insulin detemir was well tolerated in the majority of patients, with good glycemic control, sustained weight loss, and very low hypoglycemia rates.</description><identifier>ISSN: 0149-5992</identifier><identifier>EISSN: 1935-5548</identifier><identifier>DOI: 10.2337/dc11-1928</identifier><identifier>PMID: 22584132</identifier><identifier>CODEN: DICAD2</identifier><language>eng</language><publisher>United States: American Diabetes Association</publisher><subject>Adolescent ; Adult ; Aged ; Aged, 80 and over ; Blood Glucose - metabolism ; Diabetes ; Diabetes Mellitus, Type 2 - drug therapy ; Diabetes therapy ; Drug dosages ; Drug therapy ; Female ; Generalized linear models ; Glucagon-Like Peptide 1 - administration & dosage ; Glucagon-Like Peptide 1 - analogs & derivatives ; Glucagon-Like Peptide 1 - therapeutic use ; Glycated Hemoglobin A - metabolism ; Glycosylated hemoglobin ; Hemoglobin ; Humans ; Hypoglycemic agents ; Hypoglycemic Agents - administration & dosage ; Hypoglycemic Agents - therapeutic use ; Insulin ; Insulin Detemir ; Insulin, Long-Acting - administration & dosage ; Insulin, Long-Acting - therapeutic use ; Liraglutide ; Male ; Metformin - therapeutic use ; Middle Aged ; Original Research ; Pharmaceutical industry ; Plasma ; Studies ; Type 2 diabetes</subject><ispartof>Diabetes care, 2012-07, Vol.35 (7), p.1446-1454</ispartof><rights>COPYRIGHT 2012 American Diabetes Association</rights><rights>Copyright American Diabetes Association Jul 2012</rights><rights>2012 by the American Diabetes Association. 2012</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c508t-bb0e3c898b61ac3603cc5efa3ccfdce8565945f9ee13a806dcb03ac4c59d334d3</citedby><cites>FETCH-LOGICAL-c508t-bb0e3c898b61ac3603cc5efa3ccfdce8565945f9ee13a806dcb03ac4c59d334d3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>230,314,776,780,881,27901,27902</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/22584132$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>DeVries, J Hans</creatorcontrib><creatorcontrib>Bain, Stephen C</creatorcontrib><creatorcontrib>Rodbard, Helena W</creatorcontrib><creatorcontrib>Seufert, Jochen</creatorcontrib><creatorcontrib>D'Alessio, David</creatorcontrib><creatorcontrib>Thomsen, Anne B</creatorcontrib><creatorcontrib>Zychma, Marcin</creatorcontrib><creatorcontrib>Rosenstock, Julio</creatorcontrib><creatorcontrib>Liraglutide-Detemir Study Group</creatorcontrib><creatorcontrib>on behalf of the Liraglutide-Detemir Study Group</creatorcontrib><title>Sequential intensification of metformin treatment in type 2 diabetes with liraglutide followed by randomized addition of basal insulin prompted by A1C targets</title><title>Diabetes care</title><addtitle>Diabetes Care</addtitle><description>We evaluated the addition of liraglutide to metformin in type 2 diabetes followed by intensification with basal insulin (detemir) if glycated hemoglobin (A1C) ≥7%.
In 988 participants from North America and Europe uncontrolled on metformin ± sulfonylurea, sulfonylurea was discontinued and liraglutide 1.8 mg/day added for 12 weeks (run-in). Subsequently, those with A1C ≥7% were randomized 1:1 to 26 weeks' open-label addition of insulin detemir to metformin + liraglutide (n = 162) or continuation without insulin detemir (n = 161). Patients achieving A1C <7% continued unchanged treatment (observational arm). The primary end point was A1C change between randomized groups.
Of 821 participants completing the run-in, 61% (n = 498) achieved A1C <7% (mean change -1.3% from 7.7% at start), whereas 39% (n = 323) did not (-0.6% from 8.3% at start). During run-in, 167 of 988 (17%) withdrew; 46% of these due to gastrointestinal adverse events. At week 26, A1C decreased further, by 0.5% (from 7.6% at randomization) with insulin detemir (n = 162) versus 0.02% increase without insulin detemir (n = 157) to 7.1 and 7.5%, respectively (estimated treatment difference -0.52 [95% CI -0.68 to -0.36]; P < 0.0001). Forty-three percent of participants with insulin detemir versus 17% without reached A1C <7%. Mean weight decreased by 3.5 kg during run-in, then by 0.16 kg with insulin detemir or 0.95 kg without insulin detemir. In the randomized phase, no major hypoglycemia occurred and minor hypoglycemia rates were 0.286 and 0.029 events per participant-year with and without insulin detemir (9.2 vs. 1.3%).
Supplementation of metformin with liraglutide and then insulin detemir was well tolerated in the majority of patients, with good glycemic control, sustained weight loss, and very low hypoglycemia rates.</description><subject>Adolescent</subject><subject>Adult</subject><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Blood Glucose - metabolism</subject><subject>Diabetes</subject><subject>Diabetes Mellitus, Type 2 - drug therapy</subject><subject>Diabetes therapy</subject><subject>Drug dosages</subject><subject>Drug therapy</subject><subject>Female</subject><subject>Generalized linear models</subject><subject>Glucagon-Like Peptide 1 - administration & dosage</subject><subject>Glucagon-Like Peptide 1 - analogs & derivatives</subject><subject>Glucagon-Like Peptide 1 - therapeutic use</subject><subject>Glycated Hemoglobin A - metabolism</subject><subject>Glycosylated hemoglobin</subject><subject>Hemoglobin</subject><subject>Humans</subject><subject>Hypoglycemic agents</subject><subject>Hypoglycemic Agents - administration & dosage</subject><subject>Hypoglycemic Agents - therapeutic use</subject><subject>Insulin</subject><subject>Insulin Detemir</subject><subject>Insulin, Long-Acting - administration & dosage</subject><subject>Insulin, Long-Acting - therapeutic use</subject><subject>Liraglutide</subject><subject>Male</subject><subject>Metformin - therapeutic use</subject><subject>Middle Aged</subject><subject>Original Research</subject><subject>Pharmaceutical industry</subject><subject>Plasma</subject><subject>Studies</subject><subject>Type 2 diabetes</subject><issn>0149-5992</issn><issn>1935-5548</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2012</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>8G5</sourceid><sourceid>BEC</sourceid><sourceid>BENPR</sourceid><sourceid>GUQSH</sourceid><sourceid>M2O</sourceid><recordid>eNptks9uVCEUxm-Mxo7VhS9gSNzo4la4wAxsTCYT_yVNXKhrwoXDlIYLI3BtxofxWWWctmlNw-IE-J3vwJev614SfDZQunpnDSE9kYN41C2IpLznnInH3QITJnsu5XDSPSvlEmPMmBBPu5Nh4IIROiy6P9_g5wyxeh2QjxVi8c4bXX2KKDk0QXUpTz6imkHXqZHosNnvAA3Iej1ChYKufL1AwWe9DXP1FpBLIaQrsGjco6yjTZP_3XbaWn8jPeryb2aZQ1Pc5TTt6rFhTTao6ryFWp53T5wOBV5c19Pux8cP3zef-_Ovn75s1ue94VjUfhwxUCOkGJdEG7rE1BgOTrfirAHBl1wy7iQAoVrgpTUjptoww6WllFl62r0_6u7mcYLWEmvWQe2yn3Teq6S9un8T_YXapl-q2S-5oE3gzbVATs3QUtXki4EQdIQ0F0UwZZysmOANff0fepnmHNv3GjUwMQh-l9rqAMpHl9pccxBV60Eu-YpQyRrVP0BtIUJ7ZIrgfDu-x589wLdlYfLmwYa3xwaTUykZ3K0nBKtD-NQhfOoQvsa-umviLXmTNvoXylLXnw</recordid><startdate>20120701</startdate><enddate>20120701</enddate><creator>DeVries, J Hans</creator><creator>Bain, Stephen C</creator><creator>Rodbard, Helena W</creator><creator>Seufert, Jochen</creator><creator>D'Alessio, David</creator><creator>Thomsen, Anne B</creator><creator>Zychma, Marcin</creator><creator>Rosenstock, Julio</creator><general>American Diabetes Association</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>3V.</scope><scope>7RV</scope><scope>7X2</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>88I</scope><scope>8AF</scope><scope>8AO</scope><scope>8C1</scope><scope>8FE</scope><scope>8FH</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>8G5</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AN0</scope><scope>ATCPS</scope><scope>AZQEC</scope><scope>BEC</scope><scope>BENPR</scope><scope>BHPHI</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>GUQSH</scope><scope>HCIFZ</scope><scope>K9-</scope><scope>K9.</scope><scope>KB0</scope><scope>M0K</scope><scope>M0R</scope><scope>M0S</scope><scope>M0T</scope><scope>M1P</scope><scope>M2O</scope><scope>M2P</scope><scope>MBDVC</scope><scope>NAPCQ</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>Q9U</scope><scope>S0X</scope><scope>7X8</scope><scope>5PM</scope></search><sort><creationdate>20120701</creationdate><title>Sequential intensification of metformin treatment in type 2 diabetes with liraglutide followed by randomized addition of basal insulin prompted by A1C targets</title><author>DeVries, J Hans ; Bain, Stephen C ; Rodbard, Helena W ; Seufert, Jochen ; D'Alessio, David ; Thomsen, Anne B ; Zychma, Marcin ; Rosenstock, Julio</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c508t-bb0e3c898b61ac3603cc5efa3ccfdce8565945f9ee13a806dcb03ac4c59d334d3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2012</creationdate><topic>Adolescent</topic><topic>Adult</topic><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>Blood Glucose - metabolism</topic><topic>Diabetes</topic><topic>Diabetes Mellitus, Type 2 - drug therapy</topic><topic>Diabetes therapy</topic><topic>Drug dosages</topic><topic>Drug therapy</topic><topic>Female</topic><topic>Generalized linear models</topic><topic>Glucagon-Like Peptide 1 - administration & dosage</topic><topic>Glucagon-Like Peptide 1 - analogs & derivatives</topic><topic>Glucagon-Like Peptide 1 - therapeutic use</topic><topic>Glycated Hemoglobin A - metabolism</topic><topic>Glycosylated hemoglobin</topic><topic>Hemoglobin</topic><topic>Humans</topic><topic>Hypoglycemic agents</topic><topic>Hypoglycemic Agents - administration & dosage</topic><topic>Hypoglycemic Agents - therapeutic use</topic><topic>Insulin</topic><topic>Insulin Detemir</topic><topic>Insulin, Long-Acting - administration & dosage</topic><topic>Insulin, Long-Acting - therapeutic use</topic><topic>Liraglutide</topic><topic>Male</topic><topic>Metformin - therapeutic use</topic><topic>Middle Aged</topic><topic>Original Research</topic><topic>Pharmaceutical industry</topic><topic>Plasma</topic><topic>Studies</topic><topic>Type 2 diabetes</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>DeVries, J Hans</creatorcontrib><creatorcontrib>Bain, Stephen C</creatorcontrib><creatorcontrib>Rodbard, Helena W</creatorcontrib><creatorcontrib>Seufert, Jochen</creatorcontrib><creatorcontrib>D'Alessio, David</creatorcontrib><creatorcontrib>Thomsen, Anne B</creatorcontrib><creatorcontrib>Zychma, Marcin</creatorcontrib><creatorcontrib>Rosenstock, Julio</creatorcontrib><creatorcontrib>Liraglutide-Detemir Study Group</creatorcontrib><creatorcontrib>on behalf of the Liraglutide-Detemir Study Group</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Nursing & Allied Health Database</collection><collection>Agricultural Science Collection</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>Science Database (Alumni Edition)</collection><collection>STEM Database</collection><collection>ProQuest Pharma Collection</collection><collection>Public Health Database</collection><collection>ProQuest SciTech Collection</collection><collection>ProQuest Natural Science Collection</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>Research Library (Alumni Edition)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>British Nursing Database</collection><collection>Agricultural & Environmental Science Collection</collection><collection>ProQuest Central Essentials</collection><collection>eLibrary</collection><collection>ProQuest Central</collection><collection>Natural Science Collection</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 Central Student</collection><collection>Research Library Prep</collection><collection>SciTech Premium Collection</collection><collection>Consumer Health Database (Alumni Edition)</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>Agricultural Science Database</collection><collection>Consumer Health Database</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Healthcare Administration Database</collection><collection>Medical Database</collection><collection>Research Library</collection><collection>Science Database</collection><collection>Research Library (Corporate)</collection><collection>Nursing & Allied Health Premium</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>ProQuest Central Basic</collection><collection>SIRS Editorial</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Diabetes care</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>DeVries, J Hans</au><au>Bain, Stephen C</au><au>Rodbard, Helena W</au><au>Seufert, Jochen</au><au>D'Alessio, David</au><au>Thomsen, Anne B</au><au>Zychma, Marcin</au><au>Rosenstock, Julio</au><aucorp>Liraglutide-Detemir Study Group</aucorp><aucorp>on behalf of the Liraglutide-Detemir Study Group</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Sequential intensification of metformin treatment in type 2 diabetes with liraglutide followed by randomized addition of basal insulin prompted by A1C targets</atitle><jtitle>Diabetes care</jtitle><addtitle>Diabetes Care</addtitle><date>2012-07-01</date><risdate>2012</risdate><volume>35</volume><issue>7</issue><spage>1446</spage><epage>1454</epage><pages>1446-1454</pages><issn>0149-5992</issn><eissn>1935-5548</eissn><coden>DICAD2</coden><abstract>We evaluated the addition of liraglutide to metformin in type 2 diabetes followed by intensification with basal insulin (detemir) if glycated hemoglobin (A1C) ≥7%.
In 988 participants from North America and Europe uncontrolled on metformin ± sulfonylurea, sulfonylurea was discontinued and liraglutide 1.8 mg/day added for 12 weeks (run-in). Subsequently, those with A1C ≥7% were randomized 1:1 to 26 weeks' open-label addition of insulin detemir to metformin + liraglutide (n = 162) or continuation without insulin detemir (n = 161). Patients achieving A1C <7% continued unchanged treatment (observational arm). The primary end point was A1C change between randomized groups.
Of 821 participants completing the run-in, 61% (n = 498) achieved A1C <7% (mean change -1.3% from 7.7% at start), whereas 39% (n = 323) did not (-0.6% from 8.3% at start). During run-in, 167 of 988 (17%) withdrew; 46% of these due to gastrointestinal adverse events. At week 26, A1C decreased further, by 0.5% (from 7.6% at randomization) with insulin detemir (n = 162) versus 0.02% increase without insulin detemir (n = 157) to 7.1 and 7.5%, respectively (estimated treatment difference -0.52 [95% CI -0.68 to -0.36]; P < 0.0001). Forty-three percent of participants with insulin detemir versus 17% without reached A1C <7%. Mean weight decreased by 3.5 kg during run-in, then by 0.16 kg with insulin detemir or 0.95 kg without insulin detemir. In the randomized phase, no major hypoglycemia occurred and minor hypoglycemia rates were 0.286 and 0.029 events per participant-year with and without insulin detemir (9.2 vs. 1.3%).
Supplementation of metformin with liraglutide and then insulin detemir was well tolerated in the majority of patients, with good glycemic control, sustained weight loss, and very low hypoglycemia rates.</abstract><cop>United States</cop><pub>American Diabetes Association</pub><pmid>22584132</pmid><doi>10.2337/dc11-1928</doi><tpages>9</tpages><oa>free_for_read</oa></addata></record> |
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| ispartof | Diabetes care, 2012-07, Vol.35 (7), p.1446-1454 |
| issn | 0149-5992 1935-5548 |
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| source | MEDLINE; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals; Journals@Ovid Complete |
| subjects | Adolescent Adult Aged Aged, 80 and over Blood Glucose - metabolism Diabetes Diabetes Mellitus, Type 2 - drug therapy Diabetes therapy Drug dosages Drug therapy Female Generalized linear models Glucagon-Like Peptide 1 - administration & dosage Glucagon-Like Peptide 1 - analogs & derivatives Glucagon-Like Peptide 1 - therapeutic use Glycated Hemoglobin A - metabolism Glycosylated hemoglobin Hemoglobin Humans Hypoglycemic agents Hypoglycemic Agents - administration & dosage Hypoglycemic Agents - therapeutic use Insulin Insulin Detemir Insulin, Long-Acting - administration & dosage Insulin, Long-Acting - therapeutic use Liraglutide Male Metformin - therapeutic use Middle Aged Original Research Pharmaceutical industry Plasma Studies Type 2 diabetes |
| title | Sequential intensification of metformin treatment in type 2 diabetes with liraglutide followed by randomized addition of basal insulin prompted by A1C targets |
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