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Comparison of Clinical Efficacy and Safety of Metformin Sustained-Release Tablet (II) (Dulening) and Metformin Tablet (Glucophage) in Treatment of Type 2 Diabetes Mellitus
This study investigated the clinical efficacy and safety of metformin hydrochloride sustained-release (SR) tablet (II) produced by Dulening and the original metformin hydrochloride tablet produced by Glucophage in the treatment of type 2 diabetes mellitus (T2DM). This randomized, open and parallel c...
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| Published in: | Frontiers in endocrinology (Lausanne) 2021-09, Vol.12, p.712200-712200 |
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| creator | Guo, Li-Xin Liu, Guo-En Chen, Li Wang, Hai-Fang Guo, Jian Zheng, Xian-Ling Duan, Bin-Hong Wang, De-Zhong Zhu, Wei Wang, Kun Tan, Wan-Shou Chen, Qiu Li, Quan-Zhong Yang, Jing Zhang, Qiu Xie, Pei-Feng Lei, Min-Xiang |
| description | This study investigated the clinical efficacy and safety of metformin hydrochloride sustained-release (SR) tablet (II) produced by Dulening and the original metformin hydrochloride tablet produced by Glucophage in the treatment of type 2 diabetes mellitus (T2DM).
This randomized, open and parallel controlled clinical trial consecutively recruited a total of 886 patients with T2DM in 40 clinical centers between May 2016 and December 2018. These patients were randomly assigned to the Dulening group (n=446), in which patients were treated with Dulening metformin SR tablets, and the Glucophage group (n=440), in which patients were treated with Glucophage metformin tablets, for 16 weeks. The changes in the levels of glycated hemoglobin (HbAc1) and fasting blood glucose (FBG) as well as weight loss were compared between these two groups. Also, the overall incidence of adverse drug reactions (ADRs) and the incidence of ADR of the gastrointestinal system observed in patients of these two groups were also compared.
There were no significant differences in demographic and basal clinical characteristics between these two groups. The Dulening and Glucophage groups showed comparable levels of decrease in HbA1c levels, FBG and weight loss after 12-week treatment (all p>0.05). The Dulening group had a significantly lower overall incidence of ADRs as well as gastrointestinal ADR than the Glucophage group.
Metformin SR tablets (II) and the original metformin tablets exhibit similar therapeutic efficacy in the treatment of T2DM, but metformin SR tablets (II) has the significantly lower incidence of ADRs than the original metformin tablets. |
| doi_str_mv | 10.3389/fendo.2021.712200 |
| format | article |
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This randomized, open and parallel controlled clinical trial consecutively recruited a total of 886 patients with T2DM in 40 clinical centers between May 2016 and December 2018. These patients were randomly assigned to the Dulening group (n=446), in which patients were treated with Dulening metformin SR tablets, and the Glucophage group (n=440), in which patients were treated with Glucophage metformin tablets, for 16 weeks. The changes in the levels of glycated hemoglobin (HbAc1) and fasting blood glucose (FBG) as well as weight loss were compared between these two groups. Also, the overall incidence of adverse drug reactions (ADRs) and the incidence of ADR of the gastrointestinal system observed in patients of these two groups were also compared.
There were no significant differences in demographic and basal clinical characteristics between these two groups. The Dulening and Glucophage groups showed comparable levels of decrease in HbA1c levels, FBG and weight loss after 12-week treatment (all p>0.05). The Dulening group had a significantly lower overall incidence of ADRs as well as gastrointestinal ADR than the Glucophage group.
Metformin SR tablets (II) and the original metformin tablets exhibit similar therapeutic efficacy in the treatment of T2DM, but metformin SR tablets (II) has the significantly lower incidence of ADRs than the original metformin tablets.</description><identifier>ISSN: 1664-2392</identifier><identifier>EISSN: 1664-2392</identifier><identifier>DOI: 10.3389/fendo.2021.712200</identifier><identifier>PMID: 34659110</identifier><language>eng</language><publisher>Switzerland: Frontiers Media S.A</publisher><subject>Adult ; Aged ; Blood Glucose - analysis ; Delayed-Action Preparations - administration & dosage ; Delayed-Action Preparations - adverse effects ; diabetes ; Diabetes Mellitus, Type 2 - blood ; Diabetes Mellitus, Type 2 - drug therapy ; Dulening ; Endocrinology ; Glucophage ; Glycated Hemoglobin A - analysis ; Humans ; Hypoglycemic Agents ; Metformin - administration & dosage ; Metformin - adverse effects ; Metformin - therapeutic use ; metformin hydrochloride sustained-release ; Middle Aged ; Tablets ; Treatment Outcome ; type 2 diabetes mellitus</subject><ispartof>Frontiers in endocrinology (Lausanne), 2021-09, Vol.12, p.712200-712200</ispartof><rights>Copyright © 2021 Guo, Liu, Chen, Wang, Guo, Zheng, Duan, Wang, Zhu, Wang, Tan, Chen, Li, Yang, Zhang, Xie and Lei.</rights><rights>Copyright © 2021 Guo, Liu, Chen, Wang, Guo, Zheng, Duan, Wang, Zhu, Wang, Tan, Chen, Li, Yang, Zhang, Xie and Lei 2021 Guo, Liu, Chen, Wang, Guo, Zheng, Duan, Wang, Zhu, Wang, Tan, Chen, Li, Yang, Zhang, Xie and Lei</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c465t-b804fdee8fdc52ca75df86a710fa28f55c0402316c1b4c2c2f75396458a392ec3</citedby><cites>FETCH-LOGICAL-c465t-b804fdee8fdc52ca75df86a710fa28f55c0402316c1b4c2c2f75396458a392ec3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC8515195/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC8515195/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,314,723,776,780,881,27901,27902,53766,53768</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/34659110$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Guo, Li-Xin</creatorcontrib><creatorcontrib>Liu, Guo-En</creatorcontrib><creatorcontrib>Chen, Li</creatorcontrib><creatorcontrib>Wang, Hai-Fang</creatorcontrib><creatorcontrib>Guo, Jian</creatorcontrib><creatorcontrib>Zheng, Xian-Ling</creatorcontrib><creatorcontrib>Duan, Bin-Hong</creatorcontrib><creatorcontrib>Wang, De-Zhong</creatorcontrib><creatorcontrib>Zhu, Wei</creatorcontrib><creatorcontrib>Wang, Kun</creatorcontrib><creatorcontrib>Tan, Wan-Shou</creatorcontrib><creatorcontrib>Chen, Qiu</creatorcontrib><creatorcontrib>Li, Quan-Zhong</creatorcontrib><creatorcontrib>Yang, Jing</creatorcontrib><creatorcontrib>Zhang, Qiu</creatorcontrib><creatorcontrib>Xie, Pei-Feng</creatorcontrib><creatorcontrib>Lei, Min-Xiang</creatorcontrib><title>Comparison of Clinical Efficacy and Safety of Metformin Sustained-Release Tablet (II) (Dulening) and Metformin Tablet (Glucophage) in Treatment of Type 2 Diabetes Mellitus</title><title>Frontiers in endocrinology (Lausanne)</title><addtitle>Front Endocrinol (Lausanne)</addtitle><description>This study investigated the clinical efficacy and safety of metformin hydrochloride sustained-release (SR) tablet (II) produced by Dulening and the original metformin hydrochloride tablet produced by Glucophage in the treatment of type 2 diabetes mellitus (T2DM).
This randomized, open and parallel controlled clinical trial consecutively recruited a total of 886 patients with T2DM in 40 clinical centers between May 2016 and December 2018. These patients were randomly assigned to the Dulening group (n=446), in which patients were treated with Dulening metformin SR tablets, and the Glucophage group (n=440), in which patients were treated with Glucophage metformin tablets, for 16 weeks. The changes in the levels of glycated hemoglobin (HbAc1) and fasting blood glucose (FBG) as well as weight loss were compared between these two groups. Also, the overall incidence of adverse drug reactions (ADRs) and the incidence of ADR of the gastrointestinal system observed in patients of these two groups were also compared.
There were no significant differences in demographic and basal clinical characteristics between these two groups. The Dulening and Glucophage groups showed comparable levels of decrease in HbA1c levels, FBG and weight loss after 12-week treatment (all p>0.05). The Dulening group had a significantly lower overall incidence of ADRs as well as gastrointestinal ADR than the Glucophage group.
Metformin SR tablets (II) and the original metformin tablets exhibit similar therapeutic efficacy in the treatment of T2DM, but metformin SR tablets (II) has the significantly lower incidence of ADRs than the original metformin tablets.</description><subject>Adult</subject><subject>Aged</subject><subject>Blood Glucose - analysis</subject><subject>Delayed-Action Preparations - administration & dosage</subject><subject>Delayed-Action Preparations - adverse effects</subject><subject>diabetes</subject><subject>Diabetes Mellitus, Type 2 - blood</subject><subject>Diabetes Mellitus, Type 2 - drug therapy</subject><subject>Dulening</subject><subject>Endocrinology</subject><subject>Glucophage</subject><subject>Glycated Hemoglobin A - analysis</subject><subject>Humans</subject><subject>Hypoglycemic Agents</subject><subject>Metformin - administration & dosage</subject><subject>Metformin - adverse effects</subject><subject>Metformin - therapeutic use</subject><subject>metformin hydrochloride sustained-release</subject><subject>Middle Aged</subject><subject>Tablets</subject><subject>Treatment Outcome</subject><subject>type 2 diabetes mellitus</subject><issn>1664-2392</issn><issn>1664-2392</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2021</creationdate><recordtype>article</recordtype><sourceid>DOA</sourceid><recordid>eNpVUk1v2zAMNYYNa9H1B-wy6JgcklmS5diXAUP6FaDDgDU7C4xEpSpsKZPkAvlN-5OTk7ZrdaFA8r1HEq8oPtNyznnTfjXotJ-zktH5gjJWlu-KU1rX1Yzxlr1_9T8pzmN8KPOrStq2zcfihFe1aCktT4u_S9_vINjoHfGGLDvrrIKOXBqTo9oTcJrcgcG0H-s_MBkfeuvI3RATWId69gs7hIhkDZsOE5msVlMyuRg6dNZtpweC_7DnputuUH53D1uckjEdEFKPLo0i6_0OCSMXFjaYMGZ019k0xE_FBwNdxPOneFb8vrpcL29mtz-vV8vvtzOV10qzTVNWRiM2RivBFCyENk0NC1oaYI0RQuVDME5rRTeVYoqZheBtXYkG8rVQ8bNideTVHh7kLtgewl56sPKQ8GErISSrOpRVVoJS6IbxLFrplrUCsmwNWigGdeb6duTaDZsetcorBujekL6tOHsvt_5RNoIK2opMMHkiCP7PgDHJ3kaVLwIO_RAlEw3nLBtgbKXHVhV8jAHNiwwt5egZefCMHD0jj57JmC-v53tBPDuE_wPOg7-m</recordid><startdate>20210930</startdate><enddate>20210930</enddate><creator>Guo, Li-Xin</creator><creator>Liu, Guo-En</creator><creator>Chen, Li</creator><creator>Wang, Hai-Fang</creator><creator>Guo, Jian</creator><creator>Zheng, Xian-Ling</creator><creator>Duan, Bin-Hong</creator><creator>Wang, De-Zhong</creator><creator>Zhu, Wei</creator><creator>Wang, Kun</creator><creator>Tan, Wan-Shou</creator><creator>Chen, Qiu</creator><creator>Li, Quan-Zhong</creator><creator>Yang, Jing</creator><creator>Zhang, Qiu</creator><creator>Xie, Pei-Feng</creator><creator>Lei, Min-Xiang</creator><general>Frontiers Media S.A</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>7X8</scope><scope>5PM</scope><scope>DOA</scope></search><sort><creationdate>20210930</creationdate><title>Comparison of Clinical Efficacy and Safety of Metformin Sustained-Release Tablet (II) (Dulening) and Metformin Tablet (Glucophage) in Treatment of Type 2 Diabetes Mellitus</title><author>Guo, Li-Xin ; Liu, Guo-En ; Chen, Li ; Wang, Hai-Fang ; Guo, Jian ; Zheng, Xian-Ling ; Duan, Bin-Hong ; Wang, De-Zhong ; Zhu, Wei ; Wang, Kun ; Tan, Wan-Shou ; Chen, Qiu ; Li, Quan-Zhong ; Yang, Jing ; Zhang, Qiu ; Xie, Pei-Feng ; Lei, Min-Xiang</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c465t-b804fdee8fdc52ca75df86a710fa28f55c0402316c1b4c2c2f75396458a392ec3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2021</creationdate><topic>Adult</topic><topic>Aged</topic><topic>Blood Glucose - analysis</topic><topic>Delayed-Action Preparations - administration & dosage</topic><topic>Delayed-Action Preparations - adverse effects</topic><topic>diabetes</topic><topic>Diabetes Mellitus, Type 2 - blood</topic><topic>Diabetes Mellitus, Type 2 - drug therapy</topic><topic>Dulening</topic><topic>Endocrinology</topic><topic>Glucophage</topic><topic>Glycated Hemoglobin A - analysis</topic><topic>Humans</topic><topic>Hypoglycemic Agents</topic><topic>Metformin - administration & dosage</topic><topic>Metformin - adverse effects</topic><topic>Metformin - therapeutic use</topic><topic>metformin hydrochloride sustained-release</topic><topic>Middle Aged</topic><topic>Tablets</topic><topic>Treatment Outcome</topic><topic>type 2 diabetes mellitus</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Guo, Li-Xin</creatorcontrib><creatorcontrib>Liu, Guo-En</creatorcontrib><creatorcontrib>Chen, Li</creatorcontrib><creatorcontrib>Wang, Hai-Fang</creatorcontrib><creatorcontrib>Guo, Jian</creatorcontrib><creatorcontrib>Zheng, Xian-Ling</creatorcontrib><creatorcontrib>Duan, Bin-Hong</creatorcontrib><creatorcontrib>Wang, De-Zhong</creatorcontrib><creatorcontrib>Zhu, Wei</creatorcontrib><creatorcontrib>Wang, Kun</creatorcontrib><creatorcontrib>Tan, Wan-Shou</creatorcontrib><creatorcontrib>Chen, Qiu</creatorcontrib><creatorcontrib>Li, Quan-Zhong</creatorcontrib><creatorcontrib>Yang, Jing</creatorcontrib><creatorcontrib>Zhang, Qiu</creatorcontrib><creatorcontrib>Xie, Pei-Feng</creatorcontrib><creatorcontrib>Lei, Min-Xiang</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><collection>DOAJ Directory of Open Access Journals</collection><jtitle>Frontiers in endocrinology (Lausanne)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Guo, Li-Xin</au><au>Liu, Guo-En</au><au>Chen, Li</au><au>Wang, Hai-Fang</au><au>Guo, Jian</au><au>Zheng, Xian-Ling</au><au>Duan, Bin-Hong</au><au>Wang, De-Zhong</au><au>Zhu, Wei</au><au>Wang, Kun</au><au>Tan, Wan-Shou</au><au>Chen, Qiu</au><au>Li, Quan-Zhong</au><au>Yang, Jing</au><au>Zhang, Qiu</au><au>Xie, Pei-Feng</au><au>Lei, Min-Xiang</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Comparison of Clinical Efficacy and Safety of Metformin Sustained-Release Tablet (II) (Dulening) and Metformin Tablet (Glucophage) in Treatment of Type 2 Diabetes Mellitus</atitle><jtitle>Frontiers in endocrinology (Lausanne)</jtitle><addtitle>Front Endocrinol (Lausanne)</addtitle><date>2021-09-30</date><risdate>2021</risdate><volume>12</volume><spage>712200</spage><epage>712200</epage><pages>712200-712200</pages><issn>1664-2392</issn><eissn>1664-2392</eissn><abstract>This study investigated the clinical efficacy and safety of metformin hydrochloride sustained-release (SR) tablet (II) produced by Dulening and the original metformin hydrochloride tablet produced by Glucophage in the treatment of type 2 diabetes mellitus (T2DM).
This randomized, open and parallel controlled clinical trial consecutively recruited a total of 886 patients with T2DM in 40 clinical centers between May 2016 and December 2018. These patients were randomly assigned to the Dulening group (n=446), in which patients were treated with Dulening metformin SR tablets, and the Glucophage group (n=440), in which patients were treated with Glucophage metformin tablets, for 16 weeks. The changes in the levels of glycated hemoglobin (HbAc1) and fasting blood glucose (FBG) as well as weight loss were compared between these two groups. Also, the overall incidence of adverse drug reactions (ADRs) and the incidence of ADR of the gastrointestinal system observed in patients of these two groups were also compared.
There were no significant differences in demographic and basal clinical characteristics between these two groups. The Dulening and Glucophage groups showed comparable levels of decrease in HbA1c levels, FBG and weight loss after 12-week treatment (all p>0.05). The Dulening group had a significantly lower overall incidence of ADRs as well as gastrointestinal ADR than the Glucophage group.
Metformin SR tablets (II) and the original metformin tablets exhibit similar therapeutic efficacy in the treatment of T2DM, but metformin SR tablets (II) has the significantly lower incidence of ADRs than the original metformin tablets.</abstract><cop>Switzerland</cop><pub>Frontiers Media S.A</pub><pmid>34659110</pmid><doi>10.3389/fendo.2021.712200</doi><tpages>1</tpages><oa>free_for_read</oa></addata></record> |
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| subjects | Adult Aged Blood Glucose - analysis Delayed-Action Preparations - administration & dosage Delayed-Action Preparations - adverse effects diabetes Diabetes Mellitus, Type 2 - blood Diabetes Mellitus, Type 2 - drug therapy Dulening Endocrinology Glucophage Glycated Hemoglobin A - analysis Humans Hypoglycemic Agents Metformin - administration & dosage Metformin - adverse effects Metformin - therapeutic use metformin hydrochloride sustained-release Middle Aged Tablets Treatment Outcome type 2 diabetes mellitus |
| title | Comparison of Clinical Efficacy and Safety of Metformin Sustained-Release Tablet (II) (Dulening) and Metformin Tablet (Glucophage) in Treatment of Type 2 Diabetes Mellitus |
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