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Efficacy and safety of dulaglutide monotherapy compared with glimepiride in Chinese patients with type 2 diabetes: Post‐hoc analyses of a randomized, double‐blind, phase III study
Aims/Introduction To investigate the efficacy/safety of dulaglutide once‐weekly monotherapy versus glimepiride in Chinese patients with type 2 diabetes. Materials and Methods This was a post‐hoc analysis of a Chinese randomized, double‐blind, non‐inferiority, phase III study. Patients (n = 572) with...
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| Published in: | Journal of diabetes investigation 2020-01, Vol.11 (1), p.142-150 |
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| container_title | Journal of diabetes investigation |
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| creator | Shi, Li Xin Liu, Xiao Min Shi, Yong Quan Li, Quan Min Ma, Jian Hua Li, Yan Bing Du, Li Ying Wang, Feng Chen, Lu Lu |
| description | Aims/Introduction
To investigate the efficacy/safety of dulaglutide once‐weekly monotherapy versus glimepiride in Chinese patients with type 2 diabetes.
Materials and Methods
This was a post‐hoc analysis of a Chinese randomized, double‐blind, non‐inferiority, phase III study. Patients (n = 572) with inadequate glycemic control received dulaglutide 1.5 mg (n = 189) or 0.75 mg (n = 194) once‐weekly or glimepiride (1–3 mg/day; n = 189) for 26 weeks. The primary objective of the study was to investigate the non‐inferiority of dulaglutide 1.5 mg versus glimepiride by the change from baseline to week 26 in glycated hemoglobin (non‐inferiority margin 0.4%).
Results
Dulaglutide 1.5 mg and 0.75 mg were non‐inferior (P |
| doi_str_mv | 10.1111/jdi.13075 |
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| fullrecord | <record><control><sourceid>proquest_doaj_</sourceid><recordid>TN_cdi_doaj_primary_oai_doaj_org_article_91fe1aaf9d094f2f969135e10d2d30f7</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><doaj_id>oai_doaj_org_article_91fe1aaf9d094f2f969135e10d2d30f7</doaj_id><sourcerecordid>2333807757</sourcerecordid><originalsourceid>FETCH-LOGICAL-c5335-486eae6ed4f82460d174434d5a69a73b9d2de6ee2ff00a8c341469adbb1243703</originalsourceid><addsrcrecordid>eNp1kk1u1TAQgCMEolXpggsgS2xA4rV27PyxqIRKgaBKsIC1NYnH7_nJiYOdUIUVR-AIXIMtR-Ek-DXliSIxm8SZT9-MJ5MkDxk9YTFOt8qcME6L7E5ymFJBV4yl4u7-neUHyXEIWxqDl2WeF_eTA84YTXmaHyY_LrQ2LbQzgV6RABrHmThN1GRhbafRKCSd6924QQ_DTFrXDeBRkSszbsjamg4H43eU6cn5xvQYkAwwGuzHsEDjPODP7ylRBhocMTwn710Yf339tnFtrAp2Dhh2NYH42ITrzBdUz4hyU2MxYo01fTwPGwjRU9c1CeOk5gfJPQ024PHN8yj5-Oriw_mb1eW71_X5i8tVm3GerUSZI2COSugyFTlVrBCCC5VBXkHBm0qlKqYx1ZpSKFsumIgZ1TRxjLyg_CipF69ysJWDNx34WTow8vqD82sJfjStRVkxjQxAV4pWQqe6yivGM2Q01uBUF9F1triGqelQtXFIHuwt6e1MbzZy7T7LvBKi5DvBkxuBd58mDKPsTGjRWujRTUGm8a_SLF4gj-jjf9Ctm3wcd6Q45yUtimwnfLpQrXcheNT7ZhiVu_2Scb_k9X5F9tHf3e_JP9sUgdMFuDIW5_-b5NuX9aL8DXXY4BA</addsrcrecordid><sourcetype>Open Website</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2333807757</pqid></control><display><type>article</type><title>Efficacy and safety of dulaglutide monotherapy compared with glimepiride in Chinese patients with type 2 diabetes: Post‐hoc analyses of a randomized, double‐blind, phase III study</title><source>Open Access: Wiley-Blackwell Open Access Journals</source><source>Publicly Available Content (ProQuest)</source><source>PubMed Central</source><creator>Shi, Li Xin ; Liu, Xiao Min ; Shi, Yong Quan ; Li, Quan Min ; Ma, Jian Hua ; Li, Yan Bing ; Du, Li Ying ; Wang, Feng ; Chen, Lu Lu</creator><creatorcontrib>Shi, Li Xin ; Liu, Xiao Min ; Shi, Yong Quan ; Li, Quan Min ; Ma, Jian Hua ; Li, Yan Bing ; Du, Li Ying ; Wang, Feng ; Chen, Lu Lu</creatorcontrib><description>Aims/Introduction
To investigate the efficacy/safety of dulaglutide once‐weekly monotherapy versus glimepiride in Chinese patients with type 2 diabetes.
Materials and Methods
This was a post‐hoc analysis of a Chinese randomized, double‐blind, non‐inferiority, phase III study. Patients (n = 572) with inadequate glycemic control received dulaglutide 1.5 mg (n = 189) or 0.75 mg (n = 194) once‐weekly or glimepiride (1–3 mg/day; n = 189) for 26 weeks. The primary objective of the study was to investigate the non‐inferiority of dulaglutide 1.5 mg versus glimepiride by the change from baseline to week 26 in glycated hemoglobin (non‐inferiority margin 0.4%).
Results
Dulaglutide 1.5 mg and 0.75 mg were non‐inferior (P < 0.001) and superior (P ≤ 0.002) versus glimepiride for the change in glycated hemoglobin from baseline to week 26. The least‐squares mean differences (95% confidence interval) versus glimepiride were dulaglutide 1.5 mg, −0.53% (−0.74, −0.32) and dulaglutide 0.75 mg, −0.32% (−0.53, −0.12). Significantly more patients attained glycated hemoglobin <7.0% at week 26 in the dulaglutide 1.5 mg (71.7%) versus the glimepiride (57.5%; P = 0.005) group. The decrease from baseline to week 26 in fasting blood glucose was significantly more pronounced in both the dulaglutide groups versus the glimepiride group (P < 0.01). The overall incidence and rate of hypoglycemia were lower in both of the dulaglutide groups versus the glimepiride group. At week 26, bodyweight had increased from baseline in the glimepiride group and decreased from baseline in both dulaglutide groups. The most frequent gastrointestinal drug‐related adverse events with dulaglutide were diarrhea, abdominal distension, nausea and vomiting.
Conclusions
These findings support once‐weekly dulaglutide monotherapy as a treatment for Chinese patients with early stage type 2 diabetes.
This study investigated the efficacy and safety of once‐weekly dulaglutide monotherapy versus glimepiride in Chinese patients with type 2 diabetes mellitus. Once‐weekly dulaglutide 1.5 mg or 0.75 mg monotherapy provided superior glycemic control over glimepiride. The safety profile of dulaglutide in Chinese patients with type 2 diabetes mellitus was consistent with that expected for a glucagon‐like peptide‐1 receptor agonist.</description><identifier>ISSN: 2040-1116</identifier><identifier>EISSN: 2040-1124</identifier><identifier>DOI: 10.1111/jdi.13075</identifier><identifier>PMID: 31102326</identifier><language>eng</language><publisher>Japan: John Wiley & Sons, Inc</publisher><subject>Aged ; Antidiabetics ; Asian People - statistics & numerical data ; Biomarkers - analysis ; Blood Glucose - analysis ; Body mass index ; Body Weight ; Chinese ; Diabetes ; Diabetes mellitus (non-insulin dependent) ; Diabetes Mellitus, Type 2 - drug therapy ; Diabetes Mellitus, Type 2 - pathology ; Diarrhea ; Distension ; Double-Blind Method ; Double-blind studies ; Drug dosages ; Dulaglutide ; Female ; Follow-Up Studies ; Glucagon-Like Peptides - analogs & derivatives ; Glucagon-Like Peptides - therapeutic use ; Glucose ; Glycated Hemoglobin - analysis ; Hemoglobin ; Humans ; Hypoglycemia ; Hypoglycemic Agents - therapeutic use ; Immunoglobulin Fc Fragments - therapeutic use ; Insulin ; International organizations ; Male ; Middle Aged ; Nausea ; Original ; Patients ; Peptides ; Prognosis ; Recombinant Fusion Proteins - therapeutic use ; Standard deviation ; Sulfonylurea Compounds - therapeutic use ; Type 2 diabetes mellitus ; Vomiting</subject><ispartof>Journal of diabetes investigation, 2020-01, Vol.11 (1), p.142-150</ispartof><rights>2019 Eli Lilly and Company. Journal of Diabetes Investigation published by Asian Association for the Study of Diabetes (AASD) and John Wiley & Sons Australia, Ltd</rights><rights>2019 Eli Lilly and Company. Journal of Diabetes Investigation published by Asian Association for the Study of Diabetes (AASD) and John Wiley & Sons Australia, Ltd.</rights><rights>2020. This work is published under http://creativecommons.org/licenses/by-nc-nd/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c5335-486eae6ed4f82460d174434d5a69a73b9d2de6ee2ff00a8c341469adbb1243703</citedby><cites>FETCH-LOGICAL-c5335-486eae6ed4f82460d174434d5a69a73b9d2de6ee2ff00a8c341469adbb1243703</cites><orcidid>0000-0001-7242-760X</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.proquest.com/docview/2333807757/fulltextPDF?pq-origsite=primo$$EPDF$$P50$$Gproquest$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.proquest.com/docview/2333807757?pq-origsite=primo$$EHTML$$P50$$Gproquest$$Hfree_for_read</linktohtml><link.rule.ids>230,314,723,776,780,881,11542,25732,27903,27904,36991,36992,44569,46030,46454,53769,53771,74872</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/31102326$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Shi, Li Xin</creatorcontrib><creatorcontrib>Liu, Xiao Min</creatorcontrib><creatorcontrib>Shi, Yong Quan</creatorcontrib><creatorcontrib>Li, Quan Min</creatorcontrib><creatorcontrib>Ma, Jian Hua</creatorcontrib><creatorcontrib>Li, Yan Bing</creatorcontrib><creatorcontrib>Du, Li Ying</creatorcontrib><creatorcontrib>Wang, Feng</creatorcontrib><creatorcontrib>Chen, Lu Lu</creatorcontrib><title>Efficacy and safety of dulaglutide monotherapy compared with glimepiride in Chinese patients with type 2 diabetes: Post‐hoc analyses of a randomized, double‐blind, phase III study</title><title>Journal of diabetes investigation</title><addtitle>J Diabetes Investig</addtitle><description>Aims/Introduction
To investigate the efficacy/safety of dulaglutide once‐weekly monotherapy versus glimepiride in Chinese patients with type 2 diabetes.
Materials and Methods
This was a post‐hoc analysis of a Chinese randomized, double‐blind, non‐inferiority, phase III study. Patients (n = 572) with inadequate glycemic control received dulaglutide 1.5 mg (n = 189) or 0.75 mg (n = 194) once‐weekly or glimepiride (1–3 mg/day; n = 189) for 26 weeks. The primary objective of the study was to investigate the non‐inferiority of dulaglutide 1.5 mg versus glimepiride by the change from baseline to week 26 in glycated hemoglobin (non‐inferiority margin 0.4%).
Results
Dulaglutide 1.5 mg and 0.75 mg were non‐inferior (P < 0.001) and superior (P ≤ 0.002) versus glimepiride for the change in glycated hemoglobin from baseline to week 26. The least‐squares mean differences (95% confidence interval) versus glimepiride were dulaglutide 1.5 mg, −0.53% (−0.74, −0.32) and dulaglutide 0.75 mg, −0.32% (−0.53, −0.12). Significantly more patients attained glycated hemoglobin <7.0% at week 26 in the dulaglutide 1.5 mg (71.7%) versus the glimepiride (57.5%; P = 0.005) group. The decrease from baseline to week 26 in fasting blood glucose was significantly more pronounced in both the dulaglutide groups versus the glimepiride group (P < 0.01). The overall incidence and rate of hypoglycemia were lower in both of the dulaglutide groups versus the glimepiride group. At week 26, bodyweight had increased from baseline in the glimepiride group and decreased from baseline in both dulaglutide groups. The most frequent gastrointestinal drug‐related adverse events with dulaglutide were diarrhea, abdominal distension, nausea and vomiting.
Conclusions
These findings support once‐weekly dulaglutide monotherapy as a treatment for Chinese patients with early stage type 2 diabetes.
This study investigated the efficacy and safety of once‐weekly dulaglutide monotherapy versus glimepiride in Chinese patients with type 2 diabetes mellitus. Once‐weekly dulaglutide 1.5 mg or 0.75 mg monotherapy provided superior glycemic control over glimepiride. The safety profile of dulaglutide in Chinese patients with type 2 diabetes mellitus was consistent with that expected for a glucagon‐like peptide‐1 receptor agonist.</description><subject>Aged</subject><subject>Antidiabetics</subject><subject>Asian People - statistics & numerical data</subject><subject>Biomarkers - analysis</subject><subject>Blood Glucose - analysis</subject><subject>Body mass index</subject><subject>Body Weight</subject><subject>Chinese</subject><subject>Diabetes</subject><subject>Diabetes mellitus (non-insulin dependent)</subject><subject>Diabetes Mellitus, Type 2 - drug therapy</subject><subject>Diabetes Mellitus, Type 2 - pathology</subject><subject>Diarrhea</subject><subject>Distension</subject><subject>Double-Blind Method</subject><subject>Double-blind studies</subject><subject>Drug dosages</subject><subject>Dulaglutide</subject><subject>Female</subject><subject>Follow-Up Studies</subject><subject>Glucagon-Like Peptides - analogs & derivatives</subject><subject>Glucagon-Like Peptides - therapeutic use</subject><subject>Glucose</subject><subject>Glycated Hemoglobin - analysis</subject><subject>Hemoglobin</subject><subject>Humans</subject><subject>Hypoglycemia</subject><subject>Hypoglycemic Agents - therapeutic use</subject><subject>Immunoglobulin Fc Fragments - therapeutic use</subject><subject>Insulin</subject><subject>International organizations</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Nausea</subject><subject>Original</subject><subject>Patients</subject><subject>Peptides</subject><subject>Prognosis</subject><subject>Recombinant Fusion Proteins - therapeutic use</subject><subject>Standard deviation</subject><subject>Sulfonylurea Compounds - therapeutic use</subject><subject>Type 2 diabetes mellitus</subject><subject>Vomiting</subject><issn>2040-1116</issn><issn>2040-1124</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2020</creationdate><recordtype>article</recordtype><sourceid>24P</sourceid><sourceid>PIMPY</sourceid><sourceid>DOA</sourceid><recordid>eNp1kk1u1TAQgCMEolXpggsgS2xA4rV27PyxqIRKgaBKsIC1NYnH7_nJiYOdUIUVR-AIXIMtR-Ek-DXliSIxm8SZT9-MJ5MkDxk9YTFOt8qcME6L7E5ymFJBV4yl4u7-neUHyXEIWxqDl2WeF_eTA84YTXmaHyY_LrQ2LbQzgV6RABrHmThN1GRhbafRKCSd6924QQ_DTFrXDeBRkSszbsjamg4H43eU6cn5xvQYkAwwGuzHsEDjPODP7ylRBhocMTwn710Yf339tnFtrAp2Dhh2NYH42ITrzBdUz4hyU2MxYo01fTwPGwjRU9c1CeOk5gfJPQ024PHN8yj5-Oriw_mb1eW71_X5i8tVm3GerUSZI2COSugyFTlVrBCCC5VBXkHBm0qlKqYx1ZpSKFsumIgZ1TRxjLyg_CipF69ysJWDNx34WTow8vqD82sJfjStRVkxjQxAV4pWQqe6yivGM2Q01uBUF9F1triGqelQtXFIHuwt6e1MbzZy7T7LvBKi5DvBkxuBd58mDKPsTGjRWujRTUGm8a_SLF4gj-jjf9Ctm3wcd6Q45yUtimwnfLpQrXcheNT7ZhiVu_2Scb_k9X5F9tHf3e_JP9sUgdMFuDIW5_-b5NuX9aL8DXXY4BA</recordid><startdate>202001</startdate><enddate>202001</enddate><creator>Shi, Li Xin</creator><creator>Liu, Xiao Min</creator><creator>Shi, Yong Quan</creator><creator>Li, Quan Min</creator><creator>Ma, Jian Hua</creator><creator>Li, Yan Bing</creator><creator>Du, Li Ying</creator><creator>Wang, Feng</creator><creator>Chen, Lu Lu</creator><general>John Wiley & Sons, Inc</general><general>John Wiley and Sons Inc</general><general>Wiley</general><scope>24P</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>7T5</scope><scope>7TM</scope><scope>7X7</scope><scope>7XB</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>H94</scope><scope>K9.</scope><scope>M0S</scope><scope>PIMPY</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>7X8</scope><scope>5PM</scope><scope>DOA</scope><orcidid>https://orcid.org/0000-0001-7242-760X</orcidid></search><sort><creationdate>202001</creationdate><title>Efficacy and safety of dulaglutide monotherapy compared with glimepiride in Chinese patients with type 2 diabetes: Post‐hoc analyses of a randomized, double‐blind, phase III study</title><author>Shi, Li Xin ; Liu, Xiao Min ; Shi, Yong Quan ; Li, Quan Min ; Ma, Jian Hua ; Li, Yan Bing ; Du, Li Ying ; Wang, Feng ; Chen, Lu Lu</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c5335-486eae6ed4f82460d174434d5a69a73b9d2de6ee2ff00a8c341469adbb1243703</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2020</creationdate><topic>Aged</topic><topic>Antidiabetics</topic><topic>Asian People - statistics & numerical data</topic><topic>Biomarkers - analysis</topic><topic>Blood Glucose - analysis</topic><topic>Body mass index</topic><topic>Body Weight</topic><topic>Chinese</topic><topic>Diabetes</topic><topic>Diabetes mellitus (non-insulin dependent)</topic><topic>Diabetes Mellitus, Type 2 - drug therapy</topic><topic>Diabetes Mellitus, Type 2 - pathology</topic><topic>Diarrhea</topic><topic>Distension</topic><topic>Double-Blind Method</topic><topic>Double-blind studies</topic><topic>Drug dosages</topic><topic>Dulaglutide</topic><topic>Female</topic><topic>Follow-Up Studies</topic><topic>Glucagon-Like Peptides - analogs & derivatives</topic><topic>Glucagon-Like Peptides - therapeutic use</topic><topic>Glucose</topic><topic>Glycated Hemoglobin - analysis</topic><topic>Hemoglobin</topic><topic>Humans</topic><topic>Hypoglycemia</topic><topic>Hypoglycemic Agents - therapeutic use</topic><topic>Immunoglobulin Fc Fragments - therapeutic use</topic><topic>Insulin</topic><topic>International organizations</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Nausea</topic><topic>Original</topic><topic>Patients</topic><topic>Peptides</topic><topic>Prognosis</topic><topic>Recombinant Fusion Proteins - therapeutic use</topic><topic>Standard deviation</topic><topic>Sulfonylurea Compounds - therapeutic use</topic><topic>Type 2 diabetes mellitus</topic><topic>Vomiting</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Shi, Li Xin</creatorcontrib><creatorcontrib>Liu, Xiao Min</creatorcontrib><creatorcontrib>Shi, Yong Quan</creatorcontrib><creatorcontrib>Li, Quan Min</creatorcontrib><creatorcontrib>Ma, Jian Hua</creatorcontrib><creatorcontrib>Li, Yan Bing</creatorcontrib><creatorcontrib>Du, Li Ying</creatorcontrib><creatorcontrib>Wang, Feng</creatorcontrib><creatorcontrib>Chen, Lu Lu</creatorcontrib><collection>Open Access: Wiley-Blackwell Open Access Journals</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>Immunology Abstracts</collection><collection>Nucleic Acids Abstracts</collection><collection>ProQuest Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni)</collection><collection>ProQuest Central</collection><collection>ProQuest Central Essentials</collection><collection>ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Publicly Available Content (ProQuest)</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><collection>Directory of Open Access Journals</collection><jtitle>Journal of diabetes investigation</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Shi, Li Xin</au><au>Liu, Xiao Min</au><au>Shi, Yong Quan</au><au>Li, Quan Min</au><au>Ma, Jian Hua</au><au>Li, Yan Bing</au><au>Du, Li Ying</au><au>Wang, Feng</au><au>Chen, Lu Lu</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Efficacy and safety of dulaglutide monotherapy compared with glimepiride in Chinese patients with type 2 diabetes: Post‐hoc analyses of a randomized, double‐blind, phase III study</atitle><jtitle>Journal of diabetes investigation</jtitle><addtitle>J Diabetes Investig</addtitle><date>2020-01</date><risdate>2020</risdate><volume>11</volume><issue>1</issue><spage>142</spage><epage>150</epage><pages>142-150</pages><issn>2040-1116</issn><eissn>2040-1124</eissn><abstract>Aims/Introduction
To investigate the efficacy/safety of dulaglutide once‐weekly monotherapy versus glimepiride in Chinese patients with type 2 diabetes.
Materials and Methods
This was a post‐hoc analysis of a Chinese randomized, double‐blind, non‐inferiority, phase III study. Patients (n = 572) with inadequate glycemic control received dulaglutide 1.5 mg (n = 189) or 0.75 mg (n = 194) once‐weekly or glimepiride (1–3 mg/day; n = 189) for 26 weeks. The primary objective of the study was to investigate the non‐inferiority of dulaglutide 1.5 mg versus glimepiride by the change from baseline to week 26 in glycated hemoglobin (non‐inferiority margin 0.4%).
Results
Dulaglutide 1.5 mg and 0.75 mg were non‐inferior (P < 0.001) and superior (P ≤ 0.002) versus glimepiride for the change in glycated hemoglobin from baseline to week 26. The least‐squares mean differences (95% confidence interval) versus glimepiride were dulaglutide 1.5 mg, −0.53% (−0.74, −0.32) and dulaglutide 0.75 mg, −0.32% (−0.53, −0.12). Significantly more patients attained glycated hemoglobin <7.0% at week 26 in the dulaglutide 1.5 mg (71.7%) versus the glimepiride (57.5%; P = 0.005) group. The decrease from baseline to week 26 in fasting blood glucose was significantly more pronounced in both the dulaglutide groups versus the glimepiride group (P < 0.01). The overall incidence and rate of hypoglycemia were lower in both of the dulaglutide groups versus the glimepiride group. At week 26, bodyweight had increased from baseline in the glimepiride group and decreased from baseline in both dulaglutide groups. The most frequent gastrointestinal drug‐related adverse events with dulaglutide were diarrhea, abdominal distension, nausea and vomiting.
Conclusions
These findings support once‐weekly dulaglutide monotherapy as a treatment for Chinese patients with early stage type 2 diabetes.
This study investigated the efficacy and safety of once‐weekly dulaglutide monotherapy versus glimepiride in Chinese patients with type 2 diabetes mellitus. Once‐weekly dulaglutide 1.5 mg or 0.75 mg monotherapy provided superior glycemic control over glimepiride. The safety profile of dulaglutide in Chinese patients with type 2 diabetes mellitus was consistent with that expected for a glucagon‐like peptide‐1 receptor agonist.</abstract><cop>Japan</cop><pub>John Wiley & Sons, Inc</pub><pmid>31102326</pmid><doi>10.1111/jdi.13075</doi><tpages>10</tpages><orcidid>https://orcid.org/0000-0001-7242-760X</orcidid><oa>free_for_read</oa></addata></record> |
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| identifier | ISSN: 2040-1116 |
| ispartof | Journal of diabetes investigation, 2020-01, Vol.11 (1), p.142-150 |
| issn | 2040-1116 2040-1124 |
| language | eng |
| recordid | cdi_doaj_primary_oai_doaj_org_article_91fe1aaf9d094f2f969135e10d2d30f7 |
| source | Open Access: Wiley-Blackwell Open Access Journals; Publicly Available Content (ProQuest); PubMed Central |
| subjects | Aged Antidiabetics Asian People - statistics & numerical data Biomarkers - analysis Blood Glucose - analysis Body mass index Body Weight Chinese Diabetes Diabetes mellitus (non-insulin dependent) Diabetes Mellitus, Type 2 - drug therapy Diabetes Mellitus, Type 2 - pathology Diarrhea Distension Double-Blind Method Double-blind studies Drug dosages Dulaglutide Female Follow-Up Studies Glucagon-Like Peptides - analogs & derivatives Glucagon-Like Peptides - therapeutic use Glucose Glycated Hemoglobin - analysis Hemoglobin Humans Hypoglycemia Hypoglycemic Agents - therapeutic use Immunoglobulin Fc Fragments - therapeutic use Insulin International organizations Male Middle Aged Nausea Original Patients Peptides Prognosis Recombinant Fusion Proteins - therapeutic use Standard deviation Sulfonylurea Compounds - therapeutic use Type 2 diabetes mellitus Vomiting |
| title | Efficacy and safety of dulaglutide monotherapy compared with glimepiride in Chinese patients with type 2 diabetes: Post‐hoc analyses of a randomized, double‐blind, phase III study |
| url | http://sfxeu10.hosted.exlibrisgroup.com/loughborough?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-01-26T02%3A13%3A17IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_doaj_&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Efficacy%20and%20safety%20of%20dulaglutide%20monotherapy%20compared%20with%20glimepiride%20in%20Chinese%20patients%20with%20type%C2%A02%20diabetes:%20Post%E2%80%90hoc%20analyses%20of%20a%20randomized,%20double%E2%80%90blind,%20phase%C2%A0III%20study&rft.jtitle=Journal%20of%20diabetes%20investigation&rft.au=Shi,%20Li%20Xin&rft.date=2020-01&rft.volume=11&rft.issue=1&rft.spage=142&rft.epage=150&rft.pages=142-150&rft.issn=2040-1116&rft.eissn=2040-1124&rft_id=info:doi/10.1111/jdi.13075&rft_dat=%3Cproquest_doaj_%3E2333807757%3C/proquest_doaj_%3E%3Cgrp_id%3Ecdi_FETCH-LOGICAL-c5335-486eae6ed4f82460d174434d5a69a73b9d2de6ee2ff00a8c341469adbb1243703%3C/grp_id%3E%3Coa%3E%3C/oa%3E%3Curl%3E%3C/url%3E&rft_id=info:oai/&rft_pqid=2333807757&rft_id=info:pmid/31102326&rfr_iscdi=true |