Efficacy and safety of enavogliflozin, a novel SGLT2 inhibitor, in Korean people with type 2 diabetes: A 24‐week, multicentre, randomized, double‐blind, placebo‐controlled, phase III trial
Aims To evaluate the efficacy and safety of a novel sodium‐glucose cotransporter 2 inhibitor, enavogliflozin 0.3 mg monotherapy, in Korean people with type 2 diabetes mellitus (T2DM) inadequately controlled with diet and exercise. Materials and Methods This study was a randomized, double‐blind, plac...
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| Veröffentlicht in: | Diabetes, obesity & metabolism obesity & metabolism, 2023-07, Vol.25 (7), p.1865-1873 |
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| creator | Kwak, Soo Heon Han, Kyung Ah Kim, Kyung‐Soo Yu, Jae Myung Kim, EunSook Won, Jong Chul Kang, Jun Goo Chung, Choon Hee Oh, Seungjoon Choi, Sung Hee Won, Kyu Chang Kim, Sin Gon Cho, Seung Ah Cho, Bo Young Park, Kyong Soo |
| description | Aims
To evaluate the efficacy and safety of a novel sodium‐glucose cotransporter 2 inhibitor, enavogliflozin 0.3 mg monotherapy, in Korean people with type 2 diabetes mellitus (T2DM) inadequately controlled with diet and exercise.
Materials and Methods
This study was a randomized, double‐blind, placebo‐controlled trial conducted in 23 hospitals. Individuals with haemoglobin A1c (HbA1c) of 7.0%‐10.0% after at least 8 weeks of diet and exercise modification were randomized to receive enavogliflozin 0.3 mg (n = 83) or placebo (n = 84) for 24 weeks. The primary outcome was a change in HbA1c at week 24 from baseline. Secondary outcomes included the proportion of participants achieving HbA1c |
| doi_str_mv | 10.1111/dom.15046 |
| format | Article |
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To evaluate the efficacy and safety of a novel sodium‐glucose cotransporter 2 inhibitor, enavogliflozin 0.3 mg monotherapy, in Korean people with type 2 diabetes mellitus (T2DM) inadequately controlled with diet and exercise.
Materials and Methods
This study was a randomized, double‐blind, placebo‐controlled trial conducted in 23 hospitals. Individuals with haemoglobin A1c (HbA1c) of 7.0%‐10.0% after at least 8 weeks of diet and exercise modification were randomized to receive enavogliflozin 0.3 mg (n = 83) or placebo (n = 84) for 24 weeks. The primary outcome was a change in HbA1c at week 24 from baseline. Secondary outcomes included the proportion of participants achieving HbA1c <7.0%, change in fasting glucose, body weight and lipid levels. Adverse events were investigated throughout the study.
Results
At week 24, the placebo‐adjusted mean change in HbA1c from baseline in the enavogliflozin group was −0.99% (95% confidence interval −1.24%, −0.74%). The proportions of patients achieving HbA1c <7.0% (71% vs. 24%) at week 24 was significantly higher in the enavogliflozin group (p < .0001). Placebo‐adjusted mean changes in fasting plasma glucose (−40.1 mg/dl) and body weight (−2.5 kg) at week 24 were statistically significant (p < .0001). In addition, a significant decrease in blood pressure, low‐density lipoprotein cholesterol, triglyceride, and homeostasis model assessment of insulin resistance were observed, along with a significant increase in high‐density lipoprotein cholesterol. No significant increase in treatment‐related adverse events was observed for enavogliflozin.
Conclusions
Monotherapy with enavogliflozin 0.3 mg improved glycaemic control in people with T2DM. Enavogliflozin therapy also exerted beneficial effects on body weight, blood pressure and lipid profile.</description><identifier>ISSN: 1462-8902</identifier><identifier>EISSN: 1463-1326</identifier><identifier>DOI: 10.1111/dom.15046</identifier><identifier>PMID: 36872067</identifier><language>eng</language><publisher>Oxford, UK: Blackwell Publishing Ltd</publisher><subject>Adverse events ; Blood Glucose ; Blood pressure ; Body Weight ; Cholesterol ; Diabetes ; Diabetes mellitus (non-insulin dependent) ; Diabetes Mellitus, Type 2 ; Diet ; Double-Blind Method ; Double-blind studies ; Fasting ; Glucose ; Glycated Hemoglobin ; Hemoglobin ; Homeostasis ; Humans ; Hypoglycemic Agents - adverse effects ; Insulin resistance ; Lipids ; Placebos ; Republic of Korea - epidemiology ; Sodium-glucose cotransporter ; Sodium-Glucose Transporter 2 Inhibitors - adverse effects ; Statistical analysis ; Treatment Outcome</subject><ispartof>Diabetes, obesity & metabolism, 2023-07, Vol.25 (7), p.1865-1873</ispartof><rights>2023 The Authors. published by John Wiley & Sons Ltd.</rights><rights>2023 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd.</rights><rights>2023. 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><citedby>FETCH-LOGICAL-c3886-8f5cb83e4606edcc5dbd4487813e58d0fecb3130b5c51df0ce796f08410d30c43</citedby><cites>FETCH-LOGICAL-c3886-8f5cb83e4606edcc5dbd4487813e58d0fecb3130b5c51df0ce796f08410d30c43</cites><orcidid>0000-0003-1144-7206 ; 0000-0002-7430-3675 ; 0000-0002-7738-2284 ; 0000-0002-8419-9883 ; 0000-0002-8422-9966</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.15046$$EPDF$$P50$$Gwiley$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1111%2Fdom.15046$$EHTML$$P50$$Gwiley$$Hfree_for_read</linktohtml><link.rule.ids>314,776,780,1411,27903,27904,45553,45554</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/36872067$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Kwak, Soo Heon</creatorcontrib><creatorcontrib>Han, Kyung Ah</creatorcontrib><creatorcontrib>Kim, Kyung‐Soo</creatorcontrib><creatorcontrib>Yu, Jae Myung</creatorcontrib><creatorcontrib>Kim, EunSook</creatorcontrib><creatorcontrib>Won, Jong Chul</creatorcontrib><creatorcontrib>Kang, Jun Goo</creatorcontrib><creatorcontrib>Chung, Choon Hee</creatorcontrib><creatorcontrib>Oh, Seungjoon</creatorcontrib><creatorcontrib>Choi, Sung Hee</creatorcontrib><creatorcontrib>Won, Kyu Chang</creatorcontrib><creatorcontrib>Kim, Sin Gon</creatorcontrib><creatorcontrib>Cho, Seung Ah</creatorcontrib><creatorcontrib>Cho, Bo Young</creatorcontrib><creatorcontrib>Park, Kyong Soo</creatorcontrib><title>Efficacy and safety of enavogliflozin, a novel SGLT2 inhibitor, in Korean people with type 2 diabetes: A 24‐week, multicentre, randomized, double‐blind, placebo‐controlled, phase III trial</title><title>Diabetes, obesity & metabolism</title><addtitle>Diabetes Obes Metab</addtitle><description>Aims
To evaluate the efficacy and safety of a novel sodium‐glucose cotransporter 2 inhibitor, enavogliflozin 0.3 mg monotherapy, in Korean people with type 2 diabetes mellitus (T2DM) inadequately controlled with diet and exercise.
Materials and Methods
This study was a randomized, double‐blind, placebo‐controlled trial conducted in 23 hospitals. Individuals with haemoglobin A1c (HbA1c) of 7.0%‐10.0% after at least 8 weeks of diet and exercise modification were randomized to receive enavogliflozin 0.3 mg (n = 83) or placebo (n = 84) for 24 weeks. The primary outcome was a change in HbA1c at week 24 from baseline. Secondary outcomes included the proportion of participants achieving HbA1c <7.0%, change in fasting glucose, body weight and lipid levels. Adverse events were investigated throughout the study.
Results
At week 24, the placebo‐adjusted mean change in HbA1c from baseline in the enavogliflozin group was −0.99% (95% confidence interval −1.24%, −0.74%). The proportions of patients achieving HbA1c <7.0% (71% vs. 24%) at week 24 was significantly higher in the enavogliflozin group (p < .0001). Placebo‐adjusted mean changes in fasting plasma glucose (−40.1 mg/dl) and body weight (−2.5 kg) at week 24 were statistically significant (p < .0001). In addition, a significant decrease in blood pressure, low‐density lipoprotein cholesterol, triglyceride, and homeostasis model assessment of insulin resistance were observed, along with a significant increase in high‐density lipoprotein cholesterol. No significant increase in treatment‐related adverse events was observed for enavogliflozin.
Conclusions
Monotherapy with enavogliflozin 0.3 mg improved glycaemic control in people with T2DM. Enavogliflozin therapy also exerted beneficial effects on body weight, blood pressure and lipid profile.</description><subject>Adverse events</subject><subject>Blood Glucose</subject><subject>Blood pressure</subject><subject>Body Weight</subject><subject>Cholesterol</subject><subject>Diabetes</subject><subject>Diabetes mellitus (non-insulin dependent)</subject><subject>Diabetes Mellitus, Type 2</subject><subject>Diet</subject><subject>Double-Blind Method</subject><subject>Double-blind studies</subject><subject>Fasting</subject><subject>Glucose</subject><subject>Glycated Hemoglobin</subject><subject>Hemoglobin</subject><subject>Homeostasis</subject><subject>Humans</subject><subject>Hypoglycemic Agents - adverse effects</subject><subject>Insulin resistance</subject><subject>Lipids</subject><subject>Placebos</subject><subject>Republic of Korea - epidemiology</subject><subject>Sodium-glucose cotransporter</subject><subject>Sodium-Glucose Transporter 2 Inhibitors - adverse effects</subject><subject>Statistical analysis</subject><subject>Treatment Outcome</subject><issn>1462-8902</issn><issn>1463-1326</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2023</creationdate><recordtype>article</recordtype><sourceid>24P</sourceid><sourceid>EIF</sourceid><recordid>eNp10c1u1DAQB_AIgWgpHHgBNBIXkDatP_Lh5VaVUlYs6oFyjhx7zLo4cbCTrtITj8Az8Sg8Cd5u4YCELx5bP_098mTZc0qOaVon2nfHtCRF9SA7pEXFc8pZ9fCuZrlYEnaQPYnxmhBScFE_zg54JWpGqvow-3lujFVSzSB7DVEaHGfwBrCXN_6Ls8b5W9svQELvb9DBp4v1FQPbb2xrRx8WqYQPPqDsYUA_OIStHTcwzgMCA21liyPGN3AKrPj1_ccW8esCusmNVmE_BlxASA_7zt6iXoD2U-swudbZPp0HJxW2Pl0on7R3bqeGjYwIq9UKxmCle5o9MtJFfHa_H2Wf351fnb3P15cXq7PTda64EFUuTKlawbGoSIVaqVK3uihELSjHUmhiULWcctKWqqTaEIX1sjJEFJRoTlTBj7JX-9wh-G8TxrHpbFTonOzRT7FhteC1WJbFjr78h177KfSpu4YJRsvUkCBJvd4rFXyMAU0zBNvJMDeUNLvBNuljmrvBJvviPnFqO9R_5Z9JJnCyB1vrcP5_UvP28uM-8jfVSrB_</recordid><startdate>202307</startdate><enddate>202307</enddate><creator>Kwak, Soo Heon</creator><creator>Han, Kyung Ah</creator><creator>Kim, Kyung‐Soo</creator><creator>Yu, Jae Myung</creator><creator>Kim, EunSook</creator><creator>Won, Jong Chul</creator><creator>Kang, Jun Goo</creator><creator>Chung, Choon Hee</creator><creator>Oh, Seungjoon</creator><creator>Choi, Sung Hee</creator><creator>Won, Kyu Chang</creator><creator>Kim, Sin Gon</creator><creator>Cho, Seung Ah</creator><creator>Cho, Bo Young</creator><creator>Park, Kyong Soo</creator><general>Blackwell Publishing Ltd</general><general>Wiley Subscription Services, Inc</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>7T5</scope><scope>7TK</scope><scope>H94</scope><scope>K9.</scope><scope>7X8</scope><orcidid>https://orcid.org/0000-0003-1144-7206</orcidid><orcidid>https://orcid.org/0000-0002-7430-3675</orcidid><orcidid>https://orcid.org/0000-0002-7738-2284</orcidid><orcidid>https://orcid.org/0000-0002-8419-9883</orcidid><orcidid>https://orcid.org/0000-0002-8422-9966</orcidid></search><sort><creationdate>202307</creationdate><title>Efficacy and safety of enavogliflozin, a novel SGLT2 inhibitor, in Korean people with type 2 diabetes: A 24‐week, multicentre, randomized, double‐blind, placebo‐controlled, phase III trial</title><author>Kwak, Soo Heon ; Han, Kyung Ah ; Kim, Kyung‐Soo ; Yu, Jae Myung ; Kim, EunSook ; Won, Jong Chul ; Kang, Jun Goo ; Chung, Choon Hee ; Oh, Seungjoon ; Choi, Sung Hee ; Won, Kyu Chang ; Kim, Sin Gon ; Cho, Seung Ah ; Cho, Bo Young ; Park, Kyong Soo</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c3886-8f5cb83e4606edcc5dbd4487813e58d0fecb3130b5c51df0ce796f08410d30c43</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2023</creationdate><topic>Adverse events</topic><topic>Blood Glucose</topic><topic>Blood pressure</topic><topic>Body Weight</topic><topic>Cholesterol</topic><topic>Diabetes</topic><topic>Diabetes mellitus (non-insulin dependent)</topic><topic>Diabetes Mellitus, Type 2</topic><topic>Diet</topic><topic>Double-Blind Method</topic><topic>Double-blind studies</topic><topic>Fasting</topic><topic>Glucose</topic><topic>Glycated Hemoglobin</topic><topic>Hemoglobin</topic><topic>Homeostasis</topic><topic>Humans</topic><topic>Hypoglycemic Agents - adverse effects</topic><topic>Insulin resistance</topic><topic>Lipids</topic><topic>Placebos</topic><topic>Republic of Korea - epidemiology</topic><topic>Sodium-glucose cotransporter</topic><topic>Sodium-Glucose Transporter 2 Inhibitors - adverse effects</topic><topic>Statistical analysis</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Kwak, Soo Heon</creatorcontrib><creatorcontrib>Han, Kyung Ah</creatorcontrib><creatorcontrib>Kim, Kyung‐Soo</creatorcontrib><creatorcontrib>Yu, Jae Myung</creatorcontrib><creatorcontrib>Kim, EunSook</creatorcontrib><creatorcontrib>Won, Jong Chul</creatorcontrib><creatorcontrib>Kang, Jun Goo</creatorcontrib><creatorcontrib>Chung, Choon Hee</creatorcontrib><creatorcontrib>Oh, Seungjoon</creatorcontrib><creatorcontrib>Choi, Sung Hee</creatorcontrib><creatorcontrib>Won, Kyu Chang</creatorcontrib><creatorcontrib>Kim, Sin Gon</creatorcontrib><creatorcontrib>Cho, Seung Ah</creatorcontrib><creatorcontrib>Cho, Bo Young</creatorcontrib><creatorcontrib>Park, Kyong Soo</creatorcontrib><collection>Wiley Online Library Open Access</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</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>Kwak, Soo Heon</au><au>Han, Kyung Ah</au><au>Kim, Kyung‐Soo</au><au>Yu, Jae Myung</au><au>Kim, EunSook</au><au>Won, Jong Chul</au><au>Kang, Jun Goo</au><au>Chung, Choon Hee</au><au>Oh, Seungjoon</au><au>Choi, Sung Hee</au><au>Won, Kyu Chang</au><au>Kim, Sin Gon</au><au>Cho, Seung Ah</au><au>Cho, Bo Young</au><au>Park, Kyong Soo</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Efficacy and safety of enavogliflozin, a novel SGLT2 inhibitor, in Korean people with type 2 diabetes: A 24‐week, multicentre, randomized, double‐blind, placebo‐controlled, phase III trial</atitle><jtitle>Diabetes, obesity & metabolism</jtitle><addtitle>Diabetes Obes Metab</addtitle><date>2023-07</date><risdate>2023</risdate><volume>25</volume><issue>7</issue><spage>1865</spage><epage>1873</epage><pages>1865-1873</pages><issn>1462-8902</issn><eissn>1463-1326</eissn><abstract>Aims
To evaluate the efficacy and safety of a novel sodium‐glucose cotransporter 2 inhibitor, enavogliflozin 0.3 mg monotherapy, in Korean people with type 2 diabetes mellitus (T2DM) inadequately controlled with diet and exercise.
Materials and Methods
This study was a randomized, double‐blind, placebo‐controlled trial conducted in 23 hospitals. Individuals with haemoglobin A1c (HbA1c) of 7.0%‐10.0% after at least 8 weeks of diet and exercise modification were randomized to receive enavogliflozin 0.3 mg (n = 83) or placebo (n = 84) for 24 weeks. The primary outcome was a change in HbA1c at week 24 from baseline. Secondary outcomes included the proportion of participants achieving HbA1c <7.0%, change in fasting glucose, body weight and lipid levels. Adverse events were investigated throughout the study.
Results
At week 24, the placebo‐adjusted mean change in HbA1c from baseline in the enavogliflozin group was −0.99% (95% confidence interval −1.24%, −0.74%). The proportions of patients achieving HbA1c <7.0% (71% vs. 24%) at week 24 was significantly higher in the enavogliflozin group (p < .0001). Placebo‐adjusted mean changes in fasting plasma glucose (−40.1 mg/dl) and body weight (−2.5 kg) at week 24 were statistically significant (p < .0001). In addition, a significant decrease in blood pressure, low‐density lipoprotein cholesterol, triglyceride, and homeostasis model assessment of insulin resistance were observed, along with a significant increase in high‐density lipoprotein cholesterol. No significant increase in treatment‐related adverse events was observed for enavogliflozin.
Conclusions
Monotherapy with enavogliflozin 0.3 mg improved glycaemic control in people with T2DM. Enavogliflozin therapy also exerted beneficial effects on body weight, blood pressure and lipid profile.</abstract><cop>Oxford, UK</cop><pub>Blackwell Publishing Ltd</pub><pmid>36872067</pmid><doi>10.1111/dom.15046</doi><tpages>9</tpages><orcidid>https://orcid.org/0000-0003-1144-7206</orcidid><orcidid>https://orcid.org/0000-0002-7430-3675</orcidid><orcidid>https://orcid.org/0000-0002-7738-2284</orcidid><orcidid>https://orcid.org/0000-0002-8419-9883</orcidid><orcidid>https://orcid.org/0000-0002-8422-9966</orcidid><oa>free_for_read</oa></addata></record> |
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| identifier | ISSN: 1462-8902 |
| ispartof | Diabetes, obesity & metabolism, 2023-07, Vol.25 (7), p.1865-1873 |
| issn | 1462-8902 1463-1326 |
| language | eng |
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| source | MEDLINE; Wiley Online Library Journals Frontfile Complete |
| subjects | Adverse events Blood Glucose Blood pressure Body Weight Cholesterol Diabetes Diabetes mellitus (non-insulin dependent) Diabetes Mellitus, Type 2 Diet Double-Blind Method Double-blind studies Fasting Glucose Glycated Hemoglobin Hemoglobin Homeostasis Humans Hypoglycemic Agents - adverse effects Insulin resistance Lipids Placebos Republic of Korea - epidemiology Sodium-glucose cotransporter Sodium-Glucose Transporter 2 Inhibitors - adverse effects Statistical analysis Treatment Outcome |
| title | Efficacy and safety of enavogliflozin, a novel SGLT2 inhibitor, in Korean people with type 2 diabetes: A 24‐week, multicentre, randomized, double‐blind, placebo‐controlled, phase III trial |
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