Long-term safety of once-daily lixisenatide in Japanese patients with type 2 diabetes mellitus: GetGoal-Mono-Japan
Abstract Aims This 76-week, open-label, parallel-group study assessed the long-term safety of once-daily lixisenatide monotherapy in Japanese patients with type 2 diabetes mellitus. Methods Patients were randomized to receive lixisenatide in a 2-step or a 1-step dose-increase regimen. The primary ob...
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description | Abstract Aims This 76-week, open-label, parallel-group study assessed the long-term safety of once-daily lixisenatide monotherapy in Japanese patients with type 2 diabetes mellitus. Methods Patients were randomized to receive lixisenatide in a 2-step or a 1-step dose-increase regimen. The primary objective was to assess the safety of lixisenatide at week 24 by a descriptive comparison of the 2- and 1-step groups. Results As expected with treatment with a glucagon-like peptide-1 agonist, nausea was the most common treatment-emergent adverse event (2-step group: n = 12/33 [36.4%] vs 1-step group: n = 18/36 [50.0%] up to week 24). In total, 5/33 patients (15.2%; 2-step group) and 2/36 patients (5.6%; 1-step group) prematurely discontinued treatment up to week 24, mainly due to adverse events. Serious treatment-emergent adverse events occurred in 2/33 patients (6.1%; 2-step group) versus 0/36 patients (0%; 1-step group) up to week 24. Symptomatic hypoglycemia occurred in 2/33 patients (6.1%; 2-step group) versus 1/36 patients (2.8%; 1-step group) up to week 24, with no severe events reported. Glycated hemoglobin, fasting plasma glucose, and body weight were reduced from baseline at weeks 24 and 76. Conclusion In Japanese patients with type 2 diabetes mellitus, once-daily lixisenatide monotherapy was well tolerated, with less nausea with the 2-step regimen. |
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Methods Patients were randomized to receive lixisenatide in a 2-step or a 1-step dose-increase regimen. The primary objective was to assess the safety of lixisenatide at week 24 by a descriptive comparison of the 2- and 1-step groups. Results As expected with treatment with a glucagon-like peptide-1 agonist, nausea was the most common treatment-emergent adverse event (2-step group: n = 12/33 [36.4%] vs 1-step group: n = 18/36 [50.0%] up to week 24). In total, 5/33 patients (15.2%; 2-step group) and 2/36 patients (5.6%; 1-step group) prematurely discontinued treatment up to week 24, mainly due to adverse events. Serious treatment-emergent adverse events occurred in 2/33 patients (6.1%; 2-step group) versus 0/36 patients (0%; 1-step group) up to week 24. Symptomatic hypoglycemia occurred in 2/33 patients (6.1%; 2-step group) versus 1/36 patients (2.8%; 1-step group) up to week 24, with no severe events reported. Glycated hemoglobin, fasting plasma glucose, and body weight were reduced from baseline at weeks 24 and 76. Conclusion In Japanese patients with type 2 diabetes mellitus, once-daily lixisenatide monotherapy was well tolerated, with less nausea with the 2-step regimen.</description><identifier>ISSN: 1056-8727</identifier><identifier>EISSN: 1873-460X</identifier><identifier>DOI: 10.1016/j.jdiacomp.2015.07.003</identifier><identifier>PMID: 26342556</identifier><language>eng</language><publisher>United States: Elsevier Inc</publisher><subject>Adult ; Aged ; Diabetes ; Diabetes Mellitus, Type 2 - blood ; Diabetes Mellitus, Type 2 - drug therapy ; Diabetes Mellitus, Type 2 - metabolism ; Drug Administration Schedule ; Drug dosages ; Endocrinology & Metabolism ; Female ; FPG ; GLP-1 ; Glucagon-Like Peptide-1 Receptor - agonists ; Glucagon-Like Peptide-1 Receptor - metabolism ; Glucose ; Glycated Hemoglobin A - analysis ; HbA1c ; Humans ; Hyperglycemia - prevention & control ; Hypoglycemia ; Hypoglycemia - chemically induced ; Hypoglycemia - prevention & control ; Hypoglycemic Agents - administration & dosage ; Hypoglycemic Agents - adverse effects ; Hypoglycemic Agents - therapeutic use ; Incidence ; Injections, Subcutaneous ; Insulin ; Intention to Treat Analysis ; Japan - epidemiology ; Male ; Middle Aged ; Nausea ; Nausea - chemically induced ; Nausea - epidemiology ; Nausea - physiopathology ; Patient Dropouts ; Peptides - administration & dosage ; Peptides - adverse effects ; Peptides - therapeutic use ; Plasma ; Safety ; Severity of Illness Index ; Standard deviation ; TEAE ; Type 2 diabetes ; Weight Loss - drug effects</subject><ispartof>Journal of diabetes and its complications, 2015-11, Vol.29 (8), p.1304-1309</ispartof><rights>2015</rights><rights>Copyright © 2015. Published by Elsevier Inc.</rights><rights>Copyright Elsevier Limited Nov 2015</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c602t-c18bb4dc429935e590c0c0021132b29f3e148d0b98826584f1677f97b6b22ba03</citedby><cites>FETCH-LOGICAL-c602t-c18bb4dc429935e590c0c0021132b29f3e148d0b98826584f1677f97b6b22ba03</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.proquest.com/docview/1735325553?pq-origsite=primo$$EHTML$$P50$$Gproquest$$H</linktohtml><link.rule.ids>314,777,781,3537,27905,27906,45976,64364,64366,64368,72218</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/26342556$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Seino, Yutaka</creatorcontrib><creatorcontrib>Yabe, Daisuke</creatorcontrib><creatorcontrib>Takami, Akane</creatorcontrib><creatorcontrib>Niemoeller, Elisabeth</creatorcontrib><creatorcontrib>Takagi, Hiroki</creatorcontrib><title>Long-term safety of once-daily lixisenatide in Japanese patients with type 2 diabetes mellitus: GetGoal-Mono-Japan</title><title>Journal of diabetes and its complications</title><addtitle>J Diabetes Complications</addtitle><description>Abstract Aims This 76-week, open-label, parallel-group study assessed the long-term safety of once-daily lixisenatide monotherapy in Japanese patients with type 2 diabetes mellitus. Methods Patients were randomized to receive lixisenatide in a 2-step or a 1-step dose-increase regimen. The primary objective was to assess the safety of lixisenatide at week 24 by a descriptive comparison of the 2- and 1-step groups. Results As expected with treatment with a glucagon-like peptide-1 agonist, nausea was the most common treatment-emergent adverse event (2-step group: n = 12/33 [36.4%] vs 1-step group: n = 18/36 [50.0%] up to week 24). In total, 5/33 patients (15.2%; 2-step group) and 2/36 patients (5.6%; 1-step group) prematurely discontinued treatment up to week 24, mainly due to adverse events. Serious treatment-emergent adverse events occurred in 2/33 patients (6.1%; 2-step group) versus 0/36 patients (0%; 1-step group) up to week 24. Symptomatic hypoglycemia occurred in 2/33 patients (6.1%; 2-step group) versus 1/36 patients (2.8%; 1-step group) up to week 24, with no severe events reported. Glycated hemoglobin, fasting plasma glucose, and body weight were reduced from baseline at weeks 24 and 76. Conclusion In Japanese patients with type 2 diabetes mellitus, once-daily lixisenatide monotherapy was well tolerated, with less nausea with the 2-step regimen.</description><subject>Adult</subject><subject>Aged</subject><subject>Diabetes</subject><subject>Diabetes Mellitus, Type 2 - blood</subject><subject>Diabetes Mellitus, Type 2 - drug therapy</subject><subject>Diabetes Mellitus, Type 2 - metabolism</subject><subject>Drug Administration Schedule</subject><subject>Drug dosages</subject><subject>Endocrinology & Metabolism</subject><subject>Female</subject><subject>FPG</subject><subject>GLP-1</subject><subject>Glucagon-Like Peptide-1 Receptor - agonists</subject><subject>Glucagon-Like Peptide-1 Receptor - metabolism</subject><subject>Glucose</subject><subject>Glycated Hemoglobin A - analysis</subject><subject>HbA1c</subject><subject>Humans</subject><subject>Hyperglycemia - prevention & control</subject><subject>Hypoglycemia</subject><subject>Hypoglycemia - chemically induced</subject><subject>Hypoglycemia - prevention & control</subject><subject>Hypoglycemic Agents - administration & dosage</subject><subject>Hypoglycemic Agents - adverse effects</subject><subject>Hypoglycemic Agents - therapeutic use</subject><subject>Incidence</subject><subject>Injections, Subcutaneous</subject><subject>Insulin</subject><subject>Intention to Treat Analysis</subject><subject>Japan - epidemiology</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Nausea</subject><subject>Nausea - chemically induced</subject><subject>Nausea - epidemiology</subject><subject>Nausea - physiopathology</subject><subject>Patient Dropouts</subject><subject>Peptides - administration & dosage</subject><subject>Peptides - adverse effects</subject><subject>Peptides - therapeutic use</subject><subject>Plasma</subject><subject>Safety</subject><subject>Severity of Illness Index</subject><subject>Standard deviation</subject><subject>TEAE</subject><subject>Type 2 diabetes</subject><subject>Weight Loss - drug effects</subject><issn>1056-8727</issn><issn>1873-460X</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2015</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>8G5</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AZQEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><sourceid>DWQXO</sourceid><sourceid>GNUQQ</sourceid><sourceid>GUQSH</sourceid><sourceid>M2O</sourceid><recordid>eNqFkstu1DAUhiMEoqXwCpUlNmwcfInthAUCVTCABrEAJHaW45yAQxKntgPk7fF0WpC6qbywZX3n9v-nKM4pKSmh8vlQDp0z1k9LyQgVJVElIfxecUprxXElybf7-U2ExLVi6qR4FONACJFC0IfFCZO8YkLI0yLs_fwdJwgTiqaHtCHfIz9bwJ1x44ZG98dFmE1yHSA3ow9mMTNEQEv-gjlF9NulHyhtCyCGckstJIhognF0aY0v0A7SzpsRf_Szx1fRj4sHvRkjPLm-z4qvb998uXiH95927y9e77GVhCVsad22VWcr1jRcgGiIzYcwSjlrWdNzoFXdkbapayZFXfVUKtU3qpUtY60h_Kx4dsy7BH-5Qkx6ctHmxvIAfo2a1kw1jFMq7kYVz_W5EjKjT2-hg1_DnAe5oniWVfBMySNlg48xQK-X4CYTNk2JPhioB31joD4YqInS2cAceH6dfm0n6P6F3TiWgVdHALJ0vxwEHW02wkLnAtikO-_urvHyVgo7utlZM_6EDeL_eXRkmujPhzU6bBEVWX5Fa_4XkbDC2Q</recordid><startdate>20151101</startdate><enddate>20151101</enddate><creator>Seino, Yutaka</creator><creator>Yabe, Daisuke</creator><creator>Takami, Akane</creator><creator>Niemoeller, Elisabeth</creator><creator>Takagi, Hiroki</creator><general>Elsevier Inc</general><general>Elsevier Limited</general><scope>6I.</scope><scope>AAFTH</scope><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>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8AO</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>8G5</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AN0</scope><scope>ASE</scope><scope>AZQEC</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FPQ</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>GUQSH</scope><scope>K6X</scope><scope>K9-</scope><scope>K9.</scope><scope>KB0</scope><scope>M0R</scope><scope>M0S</scope><scope>M1P</scope><scope>M2O</scope><scope>MBDVC</scope><scope>NAPCQ</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>Q9U</scope><scope>7X8</scope><scope>7T5</scope><scope>H94</scope></search><sort><creationdate>20151101</creationdate><title>Long-term safety of once-daily lixisenatide in Japanese patients with type 2 diabetes mellitus: GetGoal-Mono-Japan</title><author>Seino, Yutaka ; Yabe, Daisuke ; Takami, Akane ; Niemoeller, Elisabeth ; Takagi, Hiroki</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c602t-c18bb4dc429935e590c0c0021132b29f3e148d0b98826584f1677f97b6b22ba03</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2015</creationdate><topic>Adult</topic><topic>Aged</topic><topic>Diabetes</topic><topic>Diabetes Mellitus, Type 2 - blood</topic><topic>Diabetes Mellitus, Type 2 - drug therapy</topic><topic>Diabetes Mellitus, Type 2 - metabolism</topic><topic>Drug Administration Schedule</topic><topic>Drug dosages</topic><topic>Endocrinology & Metabolism</topic><topic>Female</topic><topic>FPG</topic><topic>GLP-1</topic><topic>Glucagon-Like Peptide-1 Receptor - agonists</topic><topic>Glucagon-Like Peptide-1 Receptor - metabolism</topic><topic>Glucose</topic><topic>Glycated Hemoglobin A - analysis</topic><topic>HbA1c</topic><topic>Humans</topic><topic>Hyperglycemia - prevention & control</topic><topic>Hypoglycemia</topic><topic>Hypoglycemia - chemically induced</topic><topic>Hypoglycemia - prevention & control</topic><topic>Hypoglycemic Agents - administration & dosage</topic><topic>Hypoglycemic Agents - adverse effects</topic><topic>Hypoglycemic Agents - therapeutic use</topic><topic>Incidence</topic><topic>Injections, Subcutaneous</topic><topic>Insulin</topic><topic>Intention to Treat Analysis</topic><topic>Japan - epidemiology</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Nausea</topic><topic>Nausea - chemically induced</topic><topic>Nausea - epidemiology</topic><topic>Nausea - physiopathology</topic><topic>Patient Dropouts</topic><topic>Peptides - administration & dosage</topic><topic>Peptides - adverse effects</topic><topic>Peptides - therapeutic use</topic><topic>Plasma</topic><topic>Safety</topic><topic>Severity of Illness Index</topic><topic>Standard deviation</topic><topic>TEAE</topic><topic>Type 2 diabetes</topic><topic>Weight Loss - drug effects</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Seino, Yutaka</creatorcontrib><creatorcontrib>Yabe, Daisuke</creatorcontrib><creatorcontrib>Takami, Akane</creatorcontrib><creatorcontrib>Niemoeller, Elisabeth</creatorcontrib><creatorcontrib>Takagi, Hiroki</creatorcontrib><collection>ScienceDirect Open Access Titles</collection><collection>Elsevier:ScienceDirect:Open Access</collection><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>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>ProQuest Pharma 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>British Nursing Index</collection><collection>ProQuest Central Essentials</collection><collection>ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central Korea</collection><collection>British Nursing Index (BNI) (1985 to Present)</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>British Nursing Index</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>Medical Database</collection><collection>Research Library</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>MEDLINE - Academic</collection><collection>Immunology Abstracts</collection><collection>AIDS and Cancer Research Abstracts</collection><jtitle>Journal of diabetes and its complications</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Seino, Yutaka</au><au>Yabe, Daisuke</au><au>Takami, Akane</au><au>Niemoeller, Elisabeth</au><au>Takagi, Hiroki</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Long-term safety of once-daily lixisenatide in Japanese patients with type 2 diabetes mellitus: GetGoal-Mono-Japan</atitle><jtitle>Journal of diabetes and its complications</jtitle><addtitle>J Diabetes Complications</addtitle><date>2015-11-01</date><risdate>2015</risdate><volume>29</volume><issue>8</issue><spage>1304</spage><epage>1309</epage><pages>1304-1309</pages><issn>1056-8727</issn><eissn>1873-460X</eissn><abstract>Abstract Aims This 76-week, open-label, parallel-group study assessed the long-term safety of once-daily lixisenatide monotherapy in Japanese patients with type 2 diabetes mellitus. Methods Patients were randomized to receive lixisenatide in a 2-step or a 1-step dose-increase regimen. The primary objective was to assess the safety of lixisenatide at week 24 by a descriptive comparison of the 2- and 1-step groups. Results As expected with treatment with a glucagon-like peptide-1 agonist, nausea was the most common treatment-emergent adverse event (2-step group: n = 12/33 [36.4%] vs 1-step group: n = 18/36 [50.0%] up to week 24). In total, 5/33 patients (15.2%; 2-step group) and 2/36 patients (5.6%; 1-step group) prematurely discontinued treatment up to week 24, mainly due to adverse events. Serious treatment-emergent adverse events occurred in 2/33 patients (6.1%; 2-step group) versus 0/36 patients (0%; 1-step group) up to week 24. Symptomatic hypoglycemia occurred in 2/33 patients (6.1%; 2-step group) versus 1/36 patients (2.8%; 1-step group) up to week 24, with no severe events reported. Glycated hemoglobin, fasting plasma glucose, and body weight were reduced from baseline at weeks 24 and 76. Conclusion In Japanese patients with type 2 diabetes mellitus, once-daily lixisenatide monotherapy was well tolerated, with less nausea with the 2-step regimen.</abstract><cop>United States</cop><pub>Elsevier Inc</pub><pmid>26342556</pmid><doi>10.1016/j.jdiacomp.2015.07.003</doi><tpages>6</tpages><oa>free_for_read</oa></addata></record> |
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subjects | Adult Aged Diabetes Diabetes Mellitus, Type 2 - blood Diabetes Mellitus, Type 2 - drug therapy Diabetes Mellitus, Type 2 - metabolism Drug Administration Schedule Drug dosages Endocrinology & Metabolism Female FPG GLP-1 Glucagon-Like Peptide-1 Receptor - agonists Glucagon-Like Peptide-1 Receptor - metabolism Glucose Glycated Hemoglobin A - analysis HbA1c Humans Hyperglycemia - prevention & control Hypoglycemia Hypoglycemia - chemically induced Hypoglycemia - prevention & control Hypoglycemic Agents - administration & dosage Hypoglycemic Agents - adverse effects Hypoglycemic Agents - therapeutic use Incidence Injections, Subcutaneous Insulin Intention to Treat Analysis Japan - epidemiology Male Middle Aged Nausea Nausea - chemically induced Nausea - epidemiology Nausea - physiopathology Patient Dropouts Peptides - administration & dosage Peptides - adverse effects Peptides - therapeutic use Plasma Safety Severity of Illness Index Standard deviation TEAE Type 2 diabetes Weight Loss - drug effects |
title | Long-term safety of once-daily lixisenatide in Japanese patients with type 2 diabetes mellitus: GetGoal-Mono-Japan |
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