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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Veröffentlicht in:Journal of diabetes and its complications 2015-11, Vol.29 (8), p.1304-1309
Hauptverfasser: Seino, Yutaka, Yabe, Daisuke, Takami, Akane, Niemoeller, Elisabeth, Takagi, Hiroki
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container_end_page 1309
container_issue 8
container_start_page 1304
container_title Journal of diabetes and its complications
container_volume 29
creator Seino, Yutaka
Yabe, Daisuke
Takami, Akane
Niemoeller, Elisabeth
Takagi, Hiroki
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 &amp; 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 &amp; control ; Hypoglycemia ; Hypoglycemia - chemically induced ; Hypoglycemia - prevention &amp; control ; Hypoglycemic Agents - administration &amp; 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 &amp; 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 &amp; 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 &amp; control</subject><subject>Hypoglycemia</subject><subject>Hypoglycemia - chemically induced</subject><subject>Hypoglycemia - prevention &amp; 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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 &amp; 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 &amp; 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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.</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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issn 1056-8727
1873-460X
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source MEDLINE; Elsevier ScienceDirect Journals; ProQuest Central UK/Ireland
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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