Efficacy and safety of dapagliflozin add‐on to evogliptin plus metformin therapy in patients with type 2 diabetes: A randomized, double‐blind, placebo‐controlled study
Aim To evaluate the efficacy and safety of dapagliflozin versus placebo as an add‐on in patients with type 2 diabetes who did not achieve adequate glycaemic control with evogliptin and metformin combination. Patients and Methods In this multicentre, randomized, double‐blind, placebo‐controlled Phase...
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| Veröffentlicht in: | Diabetes, obesity & metabolism obesity & metabolism, 2024-11, Vol.26 (11), p.5065-5077 |
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| creator | Jeong, In‐Kyung Choi, Kyung Mook Han, Kyung Ah Kim, Kyoung‐Ah Kim, In Joo Han, Seung Jin Lee, Won Young Yoo, Soon Jib |
| description | Aim
To evaluate the efficacy and safety of dapagliflozin versus placebo as an add‐on in patients with type 2 diabetes who did not achieve adequate glycaemic control with evogliptin and metformin combination.
Patients and Methods
In this multicentre, randomized, double‐blind, placebo‐controlled Phase 3 trial, patients with glycated haemoglobin (HbA1c) levels ≥7.0% (≥53 mmol/mol) and ≤10.5% (≤91 mmol/mol) who had received stable‐dose metformin (≥1000 mg) and evogliptin (5 mg) for at least 8 weeks were randomized to receive dapagliflozin 10 mg or placebo once daily for 24 weeks. Participants continued treatment with metformin and evogliptin. The primary endpoint was change in HbA1c level after 24 weeks of treatment from baseline level.
Results
In total, 198 patients were randomized, and 195 patients were included in the efficacy analyses (dapagliflozin: 96, placebo: 99). At Week 24, dapagliflozin significantly reduced HbA1c levels. The least squares mean difference in HbA1c level change from baseline after 24 weeks of treatment was −0.70% (−7.7 mmol/mol) (p |
| doi_str_mv | 10.1111/dom.15838 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_3100273183</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>3100273183</sourcerecordid><originalsourceid>FETCH-LOGICAL-c2438-e536183109d95e32db4b9b3bd5f14557cedb3dab2b9e71452f63d35b061f0ecb3</originalsourceid><addsrcrecordid>eNp1kU1u1jAQhi1ERUthwQWQJTYgkdY_n_PDriotRSrqBtaRHY-pKycOtkOVrjgCF-FSnKTTfoUFEt7YM_PofWc8hLzg7IDjObRxPOCqle0jssc3tay4FPXj-7eo2o6JXfI05yvG2Ea2zROyKzshZKvqPfLrxDk_6GGlerI0awdlpdFRq2f9NXgX4o2fqLb294-fcaIlUvgesTAXTM9hyXSE4mIaMSyXkPS80ruKLh6mkum1L5e0rDNQQa3XBgrkd_SIJrSLo78B-5bauJgAaGCCnzCegx7AREwMcSophgDYWlns-ozsOB0yPH-498mX05PPx2fV-cWHj8dH59UgcMIKlKx5KznrbKdACms2pjPSWOX4RqlmAGuk1UaYDhrMCFdLK5VhNXcMBiP3yeut7pzitwVy6UefBwhBTxCX3KM0E41ED0Rf_YNexSVN2B1SXDQ1U22L1JstNaSYcwLXz8mPOq09Z_3dDnv8jf5-h8i-fFBczAj2L_lnaQgcboFrH2D9v1L__uLTVvIWOO2rlQ</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>3112760588</pqid></control><display><type>article</type><title>Efficacy and safety of dapagliflozin add‐on to evogliptin plus metformin therapy in patients with type 2 diabetes: A randomized, double‐blind, placebo‐controlled study</title><source>Wiley Online Library Journals Frontfile Complete</source><creator>Jeong, In‐Kyung ; Choi, Kyung Mook ; Han, Kyung Ah ; Kim, Kyoung‐Ah ; Kim, In Joo ; Han, Seung Jin ; Lee, Won Young ; Yoo, Soon Jib</creator><creatorcontrib>Jeong, In‐Kyung ; Choi, Kyung Mook ; Han, Kyung Ah ; Kim, Kyoung‐Ah ; Kim, In Joo ; Han, Seung Jin ; Lee, Won Young ; Yoo, Soon Jib</creatorcontrib><description>Aim
To evaluate the efficacy and safety of dapagliflozin versus placebo as an add‐on in patients with type 2 diabetes who did not achieve adequate glycaemic control with evogliptin and metformin combination.
Patients and Methods
In this multicentre, randomized, double‐blind, placebo‐controlled Phase 3 trial, patients with glycated haemoglobin (HbA1c) levels ≥7.0% (≥53 mmol/mol) and ≤10.5% (≤91 mmol/mol) who had received stable‐dose metformin (≥1000 mg) and evogliptin (5 mg) for at least 8 weeks were randomized to receive dapagliflozin 10 mg or placebo once daily for 24 weeks. Participants continued treatment with metformin and evogliptin. The primary endpoint was change in HbA1c level after 24 weeks of treatment from baseline level.
Results
In total, 198 patients were randomized, and 195 patients were included in the efficacy analyses (dapagliflozin: 96, placebo: 99). At Week 24, dapagliflozin significantly reduced HbA1c levels. The least squares mean difference in HbA1c level change from baseline after 24 weeks of treatment was −0.70% (−7.7 mmol/mol) (p < 0.0001). The proportion of participants achieving HbA1c <7.0% (≥53 mmol/mol) was higher in the dapagliflozin group than in the placebo group. Compared to placebo, dapagliflozin significantly reduced fasting plasma glucose, mean daily glucose, 2‐h postprandial plasma glucose, fasting insulin, uric acid and gamma‐glutamyl transferase levels, homeostatic model assessment for insulin resistance index, body weight, hepatic steatosis index, and albuminuria. Adiponectin level significantly increased from baseline level after 24 weeks of dapagliflozin treatment. Adverse event rates were similar in the two groups.
Conclusion
Dapagliflozin add‐on to evogliptin plus metformin improved glycaemic control and was well tolerated by the target patients.</description><identifier>ISSN: 1462-8902</identifier><identifier>ISSN: 1463-1326</identifier><identifier>EISSN: 1463-1326</identifier><identifier>DOI: 10.1111/dom.15838</identifier><identifier>PMID: 39223856</identifier><language>eng</language><publisher>Oxford, UK: Blackwell Publishing Ltd</publisher><subject>Adiponectin ; Antidiabetics ; Body weight ; dapagliflozin ; Diabetes ; Diabetes mellitus (non-insulin dependent) ; drug combination ; efficacy ; evogliptin ; Fasting ; Fatty liver ; Glucose ; Hemoglobin ; Insulin resistance ; Metformin ; Placebos ; safety ; Steatosis ; type 2 diabetes mellitus ; Uric acid</subject><ispartof>Diabetes, obesity & metabolism, 2024-11, Vol.26 (11), p.5065-5077</ispartof><rights>2024 The Author(s). published by John Wiley & Sons Ltd.</rights><rights>2024 The Author(s). Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd.</rights><rights>2024. This article 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><cites>FETCH-LOGICAL-c2438-e536183109d95e32db4b9b3bd5f14557cedb3dab2b9e71452f63d35b061f0ecb3</cites><orcidid>0000-0002-9932-4130 ; 0000-0001-7857-546X ; 0000-0003-1765-0774 ; 0000-0001-6175-0225</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1111%2Fdom.15838$$EPDF$$P50$$Gwiley$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1111%2Fdom.15838$$EHTML$$P50$$Gwiley$$Hfree_for_read</linktohtml><link.rule.ids>314,776,780,1411,27901,27902,45550,45551</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/39223856$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Jeong, In‐Kyung</creatorcontrib><creatorcontrib>Choi, Kyung Mook</creatorcontrib><creatorcontrib>Han, Kyung Ah</creatorcontrib><creatorcontrib>Kim, Kyoung‐Ah</creatorcontrib><creatorcontrib>Kim, In Joo</creatorcontrib><creatorcontrib>Han, Seung Jin</creatorcontrib><creatorcontrib>Lee, Won Young</creatorcontrib><creatorcontrib>Yoo, Soon Jib</creatorcontrib><title>Efficacy and safety of dapagliflozin add‐on to evogliptin plus metformin therapy in patients with type 2 diabetes: A randomized, double‐blind, placebo‐controlled study</title><title>Diabetes, obesity & metabolism</title><addtitle>Diabetes Obes Metab</addtitle><description>Aim
To evaluate the efficacy and safety of dapagliflozin versus placebo as an add‐on in patients with type 2 diabetes who did not achieve adequate glycaemic control with evogliptin and metformin combination.
Patients and Methods
In this multicentre, randomized, double‐blind, placebo‐controlled Phase 3 trial, patients with glycated haemoglobin (HbA1c) levels ≥7.0% (≥53 mmol/mol) and ≤10.5% (≤91 mmol/mol) who had received stable‐dose metformin (≥1000 mg) and evogliptin (5 mg) for at least 8 weeks were randomized to receive dapagliflozin 10 mg or placebo once daily for 24 weeks. Participants continued treatment with metformin and evogliptin. The primary endpoint was change in HbA1c level after 24 weeks of treatment from baseline level.
Results
In total, 198 patients were randomized, and 195 patients were included in the efficacy analyses (dapagliflozin: 96, placebo: 99). At Week 24, dapagliflozin significantly reduced HbA1c levels. The least squares mean difference in HbA1c level change from baseline after 24 weeks of treatment was −0.70% (−7.7 mmol/mol) (p < 0.0001). The proportion of participants achieving HbA1c <7.0% (≥53 mmol/mol) was higher in the dapagliflozin group than in the placebo group. Compared to placebo, dapagliflozin significantly reduced fasting plasma glucose, mean daily glucose, 2‐h postprandial plasma glucose, fasting insulin, uric acid and gamma‐glutamyl transferase levels, homeostatic model assessment for insulin resistance index, body weight, hepatic steatosis index, and albuminuria. Adiponectin level significantly increased from baseline level after 24 weeks of dapagliflozin treatment. Adverse event rates were similar in the two groups.
Conclusion
Dapagliflozin add‐on to evogliptin plus metformin improved glycaemic control and was well tolerated by the target patients.</description><subject>Adiponectin</subject><subject>Antidiabetics</subject><subject>Body weight</subject><subject>dapagliflozin</subject><subject>Diabetes</subject><subject>Diabetes mellitus (non-insulin dependent)</subject><subject>drug combination</subject><subject>efficacy</subject><subject>evogliptin</subject><subject>Fasting</subject><subject>Fatty liver</subject><subject>Glucose</subject><subject>Hemoglobin</subject><subject>Insulin resistance</subject><subject>Metformin</subject><subject>Placebos</subject><subject>safety</subject><subject>Steatosis</subject><subject>type 2 diabetes mellitus</subject><subject>Uric acid</subject><issn>1462-8902</issn><issn>1463-1326</issn><issn>1463-1326</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2024</creationdate><recordtype>article</recordtype><sourceid>24P</sourceid><recordid>eNp1kU1u1jAQhi1ERUthwQWQJTYgkdY_n_PDriotRSrqBtaRHY-pKycOtkOVrjgCF-FSnKTTfoUFEt7YM_PofWc8hLzg7IDjObRxPOCqle0jssc3tay4FPXj-7eo2o6JXfI05yvG2Ea2zROyKzshZKvqPfLrxDk_6GGlerI0awdlpdFRq2f9NXgX4o2fqLb294-fcaIlUvgesTAXTM9hyXSE4mIaMSyXkPS80ruKLh6mkum1L5e0rDNQQa3XBgrkd_SIJrSLo78B-5bauJgAaGCCnzCegx7AREwMcSophgDYWlns-ozsOB0yPH-498mX05PPx2fV-cWHj8dH59UgcMIKlKx5KznrbKdACms2pjPSWOX4RqlmAGuk1UaYDhrMCFdLK5VhNXcMBiP3yeut7pzitwVy6UefBwhBTxCX3KM0E41ED0Rf_YNexSVN2B1SXDQ1U22L1JstNaSYcwLXz8mPOq09Z_3dDnv8jf5-h8i-fFBczAj2L_lnaQgcboFrH2D9v1L__uLTVvIWOO2rlQ</recordid><startdate>202411</startdate><enddate>202411</enddate><creator>Jeong, In‐Kyung</creator><creator>Choi, Kyung Mook</creator><creator>Han, Kyung Ah</creator><creator>Kim, Kyoung‐Ah</creator><creator>Kim, In Joo</creator><creator>Han, Seung Jin</creator><creator>Lee, Won Young</creator><creator>Yoo, Soon Jib</creator><general>Blackwell Publishing Ltd</general><general>Wiley Subscription Services, Inc</general><scope>24P</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7T5</scope><scope>7TK</scope><scope>H94</scope><scope>K9.</scope><scope>7X8</scope><orcidid>https://orcid.org/0000-0002-9932-4130</orcidid><orcidid>https://orcid.org/0000-0001-7857-546X</orcidid><orcidid>https://orcid.org/0000-0003-1765-0774</orcidid><orcidid>https://orcid.org/0000-0001-6175-0225</orcidid></search><sort><creationdate>202411</creationdate><title>Efficacy and safety of dapagliflozin add‐on to evogliptin plus metformin therapy in patients with type 2 diabetes: A randomized, double‐blind, placebo‐controlled study</title><author>Jeong, In‐Kyung ; Choi, Kyung Mook ; Han, Kyung Ah ; Kim, Kyoung‐Ah ; Kim, In Joo ; Han, Seung Jin ; Lee, Won Young ; Yoo, Soon Jib</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c2438-e536183109d95e32db4b9b3bd5f14557cedb3dab2b9e71452f63d35b061f0ecb3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2024</creationdate><topic>Adiponectin</topic><topic>Antidiabetics</topic><topic>Body weight</topic><topic>dapagliflozin</topic><topic>Diabetes</topic><topic>Diabetes mellitus (non-insulin dependent)</topic><topic>drug combination</topic><topic>efficacy</topic><topic>evogliptin</topic><topic>Fasting</topic><topic>Fatty liver</topic><topic>Glucose</topic><topic>Hemoglobin</topic><topic>Insulin resistance</topic><topic>Metformin</topic><topic>Placebos</topic><topic>safety</topic><topic>Steatosis</topic><topic>type 2 diabetes mellitus</topic><topic>Uric acid</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Jeong, In‐Kyung</creatorcontrib><creatorcontrib>Choi, Kyung Mook</creatorcontrib><creatorcontrib>Han, Kyung Ah</creatorcontrib><creatorcontrib>Kim, Kyoung‐Ah</creatorcontrib><creatorcontrib>Kim, In Joo</creatorcontrib><creatorcontrib>Han, Seung Jin</creatorcontrib><creatorcontrib>Lee, Won Young</creatorcontrib><creatorcontrib>Yoo, Soon Jib</creatorcontrib><collection>Wiley Online Library Open Access</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Immunology Abstracts</collection><collection>Neurosciences Abstracts</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>MEDLINE - Academic</collection><jtitle>Diabetes, obesity & metabolism</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Jeong, In‐Kyung</au><au>Choi, Kyung Mook</au><au>Han, Kyung Ah</au><au>Kim, Kyoung‐Ah</au><au>Kim, In Joo</au><au>Han, Seung Jin</au><au>Lee, Won Young</au><au>Yoo, Soon Jib</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Efficacy and safety of dapagliflozin add‐on to evogliptin plus metformin therapy in patients with type 2 diabetes: A randomized, double‐blind, placebo‐controlled study</atitle><jtitle>Diabetes, obesity & metabolism</jtitle><addtitle>Diabetes Obes Metab</addtitle><date>2024-11</date><risdate>2024</risdate><volume>26</volume><issue>11</issue><spage>5065</spage><epage>5077</epage><pages>5065-5077</pages><issn>1462-8902</issn><issn>1463-1326</issn><eissn>1463-1326</eissn><abstract>Aim
To evaluate the efficacy and safety of dapagliflozin versus placebo as an add‐on in patients with type 2 diabetes who did not achieve adequate glycaemic control with evogliptin and metformin combination.
Patients and Methods
In this multicentre, randomized, double‐blind, placebo‐controlled Phase 3 trial, patients with glycated haemoglobin (HbA1c) levels ≥7.0% (≥53 mmol/mol) and ≤10.5% (≤91 mmol/mol) who had received stable‐dose metformin (≥1000 mg) and evogliptin (5 mg) for at least 8 weeks were randomized to receive dapagliflozin 10 mg or placebo once daily for 24 weeks. Participants continued treatment with metformin and evogliptin. The primary endpoint was change in HbA1c level after 24 weeks of treatment from baseline level.
Results
In total, 198 patients were randomized, and 195 patients were included in the efficacy analyses (dapagliflozin: 96, placebo: 99). At Week 24, dapagliflozin significantly reduced HbA1c levels. The least squares mean difference in HbA1c level change from baseline after 24 weeks of treatment was −0.70% (−7.7 mmol/mol) (p < 0.0001). The proportion of participants achieving HbA1c <7.0% (≥53 mmol/mol) was higher in the dapagliflozin group than in the placebo group. Compared to placebo, dapagliflozin significantly reduced fasting plasma glucose, mean daily glucose, 2‐h postprandial plasma glucose, fasting insulin, uric acid and gamma‐glutamyl transferase levels, homeostatic model assessment for insulin resistance index, body weight, hepatic steatosis index, and albuminuria. Adiponectin level significantly increased from baseline level after 24 weeks of dapagliflozin treatment. Adverse event rates were similar in the two groups.
Conclusion
Dapagliflozin add‐on to evogliptin plus metformin improved glycaemic control and was well tolerated by the target patients.</abstract><cop>Oxford, UK</cop><pub>Blackwell Publishing Ltd</pub><pmid>39223856</pmid><doi>10.1111/dom.15838</doi><tpages>13</tpages><orcidid>https://orcid.org/0000-0002-9932-4130</orcidid><orcidid>https://orcid.org/0000-0001-7857-546X</orcidid><orcidid>https://orcid.org/0000-0003-1765-0774</orcidid><orcidid>https://orcid.org/0000-0001-6175-0225</orcidid><oa>free_for_read</oa></addata></record> |
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| source | Wiley Online Library Journals Frontfile Complete |
| subjects | Adiponectin Antidiabetics Body weight dapagliflozin Diabetes Diabetes mellitus (non-insulin dependent) drug combination efficacy evogliptin Fasting Fatty liver Glucose Hemoglobin Insulin resistance Metformin Placebos safety Steatosis type 2 diabetes mellitus Uric acid |
| title | Efficacy and safety of dapagliflozin add‐on to evogliptin plus metformin therapy in patients with type 2 diabetes: A randomized, double‐blind, placebo‐controlled study |
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