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An exploratory clinical trial on the efficacy and safety of glucagon-like peptide-1 receptor agonist dulaglutide in patients with type 2 diabetes on maintenance hemodialysis

Abstract Background Dulaglutide is a once-weekly glucagon-like peptide-1 (GLP-1) receptor agonist approved for the treatment of type 2 diabetes mellitus (T2DM). However, the efficacy and safety of dulaglutide remain unclear in insulin-treated patients with T2DM on maintenance hemodialysis (HD). Meth...

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Published in:Renal replacement therapy 2022-06, Vol.8 (1), p.1-10, Article 26
Main Authors: Ugamura, Daisuke, Hosojima, Michihiro, Kabasawa, Hideyuki, Tanabe, Naohito, Yoshizawa, Yuta, Suzuki, Yoshiki, Saito, Akihiko, Narita, Ichiei
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cited_by cdi_FETCH-LOGICAL-c2934-f789c98936f7c14d90372611b87599dc7fb862ba703114ab9985ad7dc4400b4c3
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container_title Renal replacement therapy
container_volume 8
creator Ugamura, Daisuke
Hosojima, Michihiro
Kabasawa, Hideyuki
Tanabe, Naohito
Yoshizawa, Yuta
Suzuki, Yoshiki
Saito, Akihiko
Narita, Ichiei
description Abstract Background Dulaglutide is a once-weekly glucagon-like peptide-1 (GLP-1) receptor agonist approved for the treatment of type 2 diabetes mellitus (T2DM). However, the efficacy and safety of dulaglutide remain unclear in insulin-treated patients with T2DM on maintenance hemodialysis (HD). Methods Dulaglutide treatment was initiated, and the insulin dose was adjusted according to the needs of individual participants. Primary outcomes were changes in the mean and standard deviation (SD) of blood glucose (BG) levels and mean amplitude of glycemic excursions (MAGE) evaluated by continuous glucose monitoring (CGM) for six days, glycated albumin (GA), glycated hemoglobin (HbA1c), pre-dialysis blood glucose levels, and daily total insulin dose from the baseline over 24 weeks. Secondary outcomes were changes in treatment satisfaction and QOL levels from the baseline, measured by using the Diabetes Treatment Satisfaction Questionnaire (DTSQ) and the Diabetes Therapy-Related Quality of Life questionnaire (DTR-QOL) scores. Results The analysis was performed on the 12 participants who completed the study. The GA level (median − 1.8 [interquartile range − 6.6, − 0.3] %; p = 0.026) and daily total insulin dose (− 15.0 [− 24.5, − 9.4] U/day; p = 0.002) significantly decreased without increasing hypoglycemia (area over the glucose curve 
doi_str_mv 10.1186/s41100-022-00409-4
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However, the efficacy and safety of dulaglutide remain unclear in insulin-treated patients with T2DM on maintenance hemodialysis (HD). Methods Dulaglutide treatment was initiated, and the insulin dose was adjusted according to the needs of individual participants. Primary outcomes were changes in the mean and standard deviation (SD) of blood glucose (BG) levels and mean amplitude of glycemic excursions (MAGE) evaluated by continuous glucose monitoring (CGM) for six days, glycated albumin (GA), glycated hemoglobin (HbA1c), pre-dialysis blood glucose levels, and daily total insulin dose from the baseline over 24 weeks. Secondary outcomes were changes in treatment satisfaction and QOL levels from the baseline, measured by using the Diabetes Treatment Satisfaction Questionnaire (DTSQ) and the Diabetes Therapy-Related Quality of Life questionnaire (DTR-QOL) scores. Results The analysis was performed on the 12 participants who completed the study. The GA level (median − 1.8 [interquartile range − 6.6, − 0.3] %; p = 0.026) and daily total insulin dose (− 15.0 [− 24.5, − 9.4] U/day; p = 0.002) significantly decreased without increasing hypoglycemia (area over the glucose curve &lt; 70 mg/dL: 0.0 [− 0.2, 0.0] mg·24 h/dl; p = 0.917). Four patients successfully withdrew from insulin therapy. The levels of HbA1c, SD of BG, and MAGE showed a decreasing tendency, but no significant improvement. Regarding treatment satisfaction and QOL, the total scores of DTSQ (8.0 [0.3, 12.5]; p = 0.041) and DTR-QOL (15.5 [− 1.8, 42.0]; p = 0.023) significantly improved. Conclusion Dulaglutide may help improve glycemic control, treatment satisfaction, and QOL without increasing hypoglycemia in insulin-treated patients with T2DM on maintenance HD. Trial registration This study was registered with the University Hospital Medical Information Network-Clinical Trials Registry (UMIN-CTR) on October 11, 2016 (registration ID, UMIN000024283).</description><identifier>ISSN: 2059-1381</identifier><identifier>EISSN: 2059-1381</identifier><identifier>DOI: 10.1186/s41100-022-00409-4</identifier><language>eng</language><publisher>BMC</publisher><subject>Dulaglutide ; Glucagon-like peptide-1 receptor agonist ; Hemodialysis ; Once-weekly ; Type 2 diabetes mellitus</subject><ispartof>Renal replacement therapy, 2022-06, Vol.8 (1), p.1-10, Article 26</ispartof><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c2934-f789c98936f7c14d90372611b87599dc7fb862ba703114ab9985ad7dc4400b4c3</citedby><cites>FETCH-LOGICAL-c2934-f789c98936f7c14d90372611b87599dc7fb862ba703114ab9985ad7dc4400b4c3</cites><orcidid>0000-0002-2750-735X</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,27924,27925</link.rule.ids></links><search><creatorcontrib>Ugamura, Daisuke</creatorcontrib><creatorcontrib>Hosojima, Michihiro</creatorcontrib><creatorcontrib>Kabasawa, Hideyuki</creatorcontrib><creatorcontrib>Tanabe, Naohito</creatorcontrib><creatorcontrib>Yoshizawa, Yuta</creatorcontrib><creatorcontrib>Suzuki, Yoshiki</creatorcontrib><creatorcontrib>Saito, Akihiko</creatorcontrib><creatorcontrib>Narita, Ichiei</creatorcontrib><title>An exploratory clinical trial on the efficacy and safety of glucagon-like peptide-1 receptor agonist dulaglutide in patients with type 2 diabetes on maintenance hemodialysis</title><title>Renal replacement therapy</title><description>Abstract Background Dulaglutide is a once-weekly glucagon-like peptide-1 (GLP-1) receptor agonist approved for the treatment of type 2 diabetes mellitus (T2DM). However, the efficacy and safety of dulaglutide remain unclear in insulin-treated patients with T2DM on maintenance hemodialysis (HD). Methods Dulaglutide treatment was initiated, and the insulin dose was adjusted according to the needs of individual participants. Primary outcomes were changes in the mean and standard deviation (SD) of blood glucose (BG) levels and mean amplitude of glycemic excursions (MAGE) evaluated by continuous glucose monitoring (CGM) for six days, glycated albumin (GA), glycated hemoglobin (HbA1c), pre-dialysis blood glucose levels, and daily total insulin dose from the baseline over 24 weeks. Secondary outcomes were changes in treatment satisfaction and QOL levels from the baseline, measured by using the Diabetes Treatment Satisfaction Questionnaire (DTSQ) and the Diabetes Therapy-Related Quality of Life questionnaire (DTR-QOL) scores. Results The analysis was performed on the 12 participants who completed the study. The GA level (median − 1.8 [interquartile range − 6.6, − 0.3] %; p = 0.026) and daily total insulin dose (− 15.0 [− 24.5, − 9.4] U/day; p = 0.002) significantly decreased without increasing hypoglycemia (area over the glucose curve &lt; 70 mg/dL: 0.0 [− 0.2, 0.0] mg·24 h/dl; p = 0.917). Four patients successfully withdrew from insulin therapy. The levels of HbA1c, SD of BG, and MAGE showed a decreasing tendency, but no significant improvement. Regarding treatment satisfaction and QOL, the total scores of DTSQ (8.0 [0.3, 12.5]; p = 0.041) and DTR-QOL (15.5 [− 1.8, 42.0]; p = 0.023) significantly improved. Conclusion Dulaglutide may help improve glycemic control, treatment satisfaction, and QOL without increasing hypoglycemia in insulin-treated patients with T2DM on maintenance HD. Trial registration This study was registered with the University Hospital Medical Information Network-Clinical Trials Registry (UMIN-CTR) on October 11, 2016 (registration ID, UMIN000024283).</description><subject>Dulaglutide</subject><subject>Glucagon-like peptide-1 receptor agonist</subject><subject>Hemodialysis</subject><subject>Once-weekly</subject><subject>Type 2 diabetes mellitus</subject><issn>2059-1381</issn><issn>2059-1381</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2022</creationdate><recordtype>article</recordtype><sourceid>DOA</sourceid><recordid>eNpNkU1uFDEQhVsIJKKQC7CqCzT4r9v2Mor4iRSJDawtt12ecfDYLdsR9KG4Iz0ZFLGpenqv9NXiDcN7Sj5QquaPTVBKyEgYGwkRRI_i1XDFyKRHyhV9_Z9-O9y09kgIoTOXlKmr4c9tBvy9plJtL3UDl2KOziboNe6zZOhHBAxhN90GNntoNmDfoAQ4pCdnDyWPKf5EWHHt0eNIoaLbdalwDmPr4J-S3Y_PMcQMq-0Rc2_wK_Yj9G1FYOCjXbBjO_882Zg7ZpsdwhFPZc_S1mJ7N7wJNjW8-bevhx-fP32_-zo-fPtyf3f7MDqmuRiDVNpppfkcpKPCa8IlmyldlJy09k6GRc1ssZJwSoVdtFaT9dI7IQhZhOPXw_2F64t9NGuNJ1s3U2w0z0apB2Nrjy6h0UKJhSIqNUmBQWvNhFrQEaVQCD7tLHZhuVpaqxheeJSYc3_m0p_Z-zPP_RnB_wK1GZBB</recordid><startdate>20220611</startdate><enddate>20220611</enddate><creator>Ugamura, Daisuke</creator><creator>Hosojima, Michihiro</creator><creator>Kabasawa, Hideyuki</creator><creator>Tanabe, Naohito</creator><creator>Yoshizawa, Yuta</creator><creator>Suzuki, Yoshiki</creator><creator>Saito, Akihiko</creator><creator>Narita, Ichiei</creator><general>BMC</general><scope>AAYXX</scope><scope>CITATION</scope><scope>DOA</scope><orcidid>https://orcid.org/0000-0002-2750-735X</orcidid></search><sort><creationdate>20220611</creationdate><title>An exploratory clinical trial on the efficacy and safety of glucagon-like peptide-1 receptor agonist dulaglutide in patients with type 2 diabetes on maintenance hemodialysis</title><author>Ugamura, Daisuke ; Hosojima, Michihiro ; Kabasawa, Hideyuki ; Tanabe, Naohito ; Yoshizawa, Yuta ; Suzuki, Yoshiki ; Saito, Akihiko ; Narita, Ichiei</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c2934-f789c98936f7c14d90372611b87599dc7fb862ba703114ab9985ad7dc4400b4c3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2022</creationdate><topic>Dulaglutide</topic><topic>Glucagon-like peptide-1 receptor agonist</topic><topic>Hemodialysis</topic><topic>Once-weekly</topic><topic>Type 2 diabetes mellitus</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Ugamura, Daisuke</creatorcontrib><creatorcontrib>Hosojima, Michihiro</creatorcontrib><creatorcontrib>Kabasawa, Hideyuki</creatorcontrib><creatorcontrib>Tanabe, Naohito</creatorcontrib><creatorcontrib>Yoshizawa, Yuta</creatorcontrib><creatorcontrib>Suzuki, Yoshiki</creatorcontrib><creatorcontrib>Saito, Akihiko</creatorcontrib><creatorcontrib>Narita, Ichiei</creatorcontrib><collection>CrossRef</collection><collection>DOAJ Directory of Open Access Journals</collection><jtitle>Renal replacement therapy</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Ugamura, Daisuke</au><au>Hosojima, Michihiro</au><au>Kabasawa, Hideyuki</au><au>Tanabe, Naohito</au><au>Yoshizawa, Yuta</au><au>Suzuki, Yoshiki</au><au>Saito, Akihiko</au><au>Narita, Ichiei</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>An exploratory clinical trial on the efficacy and safety of glucagon-like peptide-1 receptor agonist dulaglutide in patients with type 2 diabetes on maintenance hemodialysis</atitle><jtitle>Renal replacement therapy</jtitle><date>2022-06-11</date><risdate>2022</risdate><volume>8</volume><issue>1</issue><spage>1</spage><epage>10</epage><pages>1-10</pages><artnum>26</artnum><issn>2059-1381</issn><eissn>2059-1381</eissn><abstract>Abstract Background Dulaglutide is a once-weekly glucagon-like peptide-1 (GLP-1) receptor agonist approved for the treatment of type 2 diabetes mellitus (T2DM). However, the efficacy and safety of dulaglutide remain unclear in insulin-treated patients with T2DM on maintenance hemodialysis (HD). Methods Dulaglutide treatment was initiated, and the insulin dose was adjusted according to the needs of individual participants. Primary outcomes were changes in the mean and standard deviation (SD) of blood glucose (BG) levels and mean amplitude of glycemic excursions (MAGE) evaluated by continuous glucose monitoring (CGM) for six days, glycated albumin (GA), glycated hemoglobin (HbA1c), pre-dialysis blood glucose levels, and daily total insulin dose from the baseline over 24 weeks. Secondary outcomes were changes in treatment satisfaction and QOL levels from the baseline, measured by using the Diabetes Treatment Satisfaction Questionnaire (DTSQ) and the Diabetes Therapy-Related Quality of Life questionnaire (DTR-QOL) scores. Results The analysis was performed on the 12 participants who completed the study. The GA level (median − 1.8 [interquartile range − 6.6, − 0.3] %; p = 0.026) and daily total insulin dose (− 15.0 [− 24.5, − 9.4] U/day; p = 0.002) significantly decreased without increasing hypoglycemia (area over the glucose curve &lt; 70 mg/dL: 0.0 [− 0.2, 0.0] mg·24 h/dl; p = 0.917). Four patients successfully withdrew from insulin therapy. The levels of HbA1c, SD of BG, and MAGE showed a decreasing tendency, but no significant improvement. Regarding treatment satisfaction and QOL, the total scores of DTSQ (8.0 [0.3, 12.5]; p = 0.041) and DTR-QOL (15.5 [− 1.8, 42.0]; p = 0.023) significantly improved. Conclusion Dulaglutide may help improve glycemic control, treatment satisfaction, and QOL without increasing hypoglycemia in insulin-treated patients with T2DM on maintenance HD. Trial registration This study was registered with the University Hospital Medical Information Network-Clinical Trials Registry (UMIN-CTR) on October 11, 2016 (registration ID, UMIN000024283).</abstract><pub>BMC</pub><doi>10.1186/s41100-022-00409-4</doi><tpages>10</tpages><orcidid>https://orcid.org/0000-0002-2750-735X</orcidid><oa>free_for_read</oa></addata></record>
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subjects Dulaglutide
Glucagon-like peptide-1 receptor agonist
Hemodialysis
Once-weekly
Type 2 diabetes mellitus
title An exploratory clinical trial on the efficacy and safety of glucagon-like peptide-1 receptor agonist dulaglutide in patients with type 2 diabetes on maintenance hemodialysis
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