Dorzagliatin in drug-naïve patients with type 2 diabetes: a randomized, double-blind, placebo-controlled phase 3 trial
Improving glucose sensitivity remains an unmet medical need in treating type 2 diabetes (T2D). Dorzagliatin is a dual-acting, orally bioavailable glucokinase activator that enhances glucokinase activity in a glucose-dependent manner, improves glucose-stimulated insulin secretion and demonstrates eff...
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| Veröffentlicht in: | Nature medicine 2022-05, Vol.28 (5), p.965-973 |
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| creator | Zhu, Dalong Li, Xiaoying Ma, Jianhua Zeng, Jiao’e Gan, Shenglian Dong, Xiaolin Yang, Jing Lin, Xiaohong Cai, Hanqing Song, Weihong Li, Xuefeng Zhang, Keqin Zhang, Qiu Lu, Yibing Bu, Ruifang Shao, Huige Wang, Guixia Yuan, Guoyue Ran, Xingwu Liao, Lin Zhao, Wenjuan Li, Ping Sun, Li Shi, Lixin Jiang, Zhaoshun Xue, Yaoming Jiang, Hongwei Li, Quanmin Li, Zongbao Fu, Maoxiong Liang, Zerong Guo, Lian Liu, Ming Xu, Chun Li, Wenhui Yu, Xuefeng Qin, Guijun Yang, Zhou Su, Benli Zeng, Longyi Geng, Houfa Shi, Yongquan Zhao, Yu Zhang, Yi Yang, Wenying Chen, Li |
| description | Improving glucose sensitivity remains an unmet medical need in treating type 2 diabetes (T2D). Dorzagliatin is a dual-acting, orally bioavailable glucokinase activator that enhances glucokinase activity in a glucose-dependent manner, improves glucose-stimulated insulin secretion and demonstrates effects on glycemic control in patients with T2D. We report the findings of a randomized, double-blind, placebo-controlled phase 3 clinical trial to evaluate the efficacy and safety of dorzagliatin in patients with T2D. Eligible drug-naïve patients with T2D (
n
= 463) were randomly assigned to the dorzagliatin or placebo group at a ratio of 2:1 for 24 weeks of double-blind treatment, followed by 28 weeks of open-label treatment with dorzagliatin for all patients. The primary efficacy endpoint was the change in glycated hemoglobin from baseline to week 24. Safety was assessed throughout the trial. At week 24, the least-squares mean change in glycated hemoglobin from baseline (95% confidence interval) was −1.07% (−1.19%, −0.95%) in the dorzagliatin group and −0.50% (−0.68%, −0.32%) in the placebo group (estimated treatment difference, −0.57%; 95% confidence interval: −0.79%, −0.36%;
P
|
| doi_str_mv | 10.1038/s41591-022-01802-6 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_2664784000</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>2666123944</sourcerecordid><originalsourceid>FETCH-LOGICAL-c419t-b9f3c541c647e530ca494b7189c439b59edf28342e0bc9982e677277cef4cf023</originalsourceid><addsrcrecordid>eNp9kc1uFSEYhonR2PboDbgwJG5cFOV3ZnDX1N-kiRtN3BFgvjml4cAIMzbtTXkR3pgcT9XEhQkJfPB8L4QHoSeMvmBUDC-rZEozQjknlA2Uk-4eOmZKdoT19Mv9tqb9QAatuiN0UusVpVRQpR-iI6GUYlzLY3T9Opdbu43BLiHhNsaybkmyP75_Azy3TUhLxddhucTLzQyY4zFYBwvUV9jiYtOYd-EWxlM85tVFIC6G1Ko5Wg8uE5_TUnKMMOL50lbAAi8l2PgIPZhsrPD4bt6gz2_ffDp_Ty4-vvtwfnZBvGR6IU5PwivJfCd7UIJ6K7V0PRu0l0I7pWGc-CAkB-q81gOHru9533uYpJ8oFxv0_JA7l_x1hbqYXageYrQJ8loN71ryIPdfs0HP_kGv8lpSe92e6hgXWspG8QPlS661wGTmEna23BhGzV6LOWgxTYv5pcV0renpXfTqdjD-afntoQHiANR2lLZQ_t79n9ifWt2Yeg</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2666123944</pqid></control><display><type>article</type><title>Dorzagliatin in drug-naïve patients with type 2 diabetes: a randomized, double-blind, placebo-controlled phase 3 trial</title><source>MEDLINE</source><source>Nature Journals Online</source><source>SpringerLink (Online service)</source><creator>Zhu, Dalong ; Li, Xiaoying ; Ma, Jianhua ; Zeng, Jiao’e ; Gan, Shenglian ; Dong, Xiaolin ; Yang, Jing ; Lin, Xiaohong ; Cai, Hanqing ; Song, Weihong ; Li, Xuefeng ; Zhang, Keqin ; Zhang, Qiu ; Lu, Yibing ; Bu, Ruifang ; Shao, Huige ; Wang, Guixia ; Yuan, Guoyue ; Ran, Xingwu ; Liao, Lin ; Zhao, Wenjuan ; Li, Ping ; Sun, Li ; Shi, Lixin ; Jiang, Zhaoshun ; Xue, Yaoming ; Jiang, Hongwei ; Li, Quanmin ; Li, Zongbao ; Fu, Maoxiong ; Liang, Zerong ; Guo, Lian ; Liu, Ming ; Xu, Chun ; Li, Wenhui ; Yu, Xuefeng ; Qin, Guijun ; Yang, Zhou ; Su, Benli ; Zeng, Longyi ; Geng, Houfa ; Shi, Yongquan ; Zhao, Yu ; Zhang, Yi ; Yang, Wenying ; Chen, Li</creator><creatorcontrib>Zhu, Dalong ; Li, Xiaoying ; Ma, Jianhua ; Zeng, Jiao’e ; Gan, Shenglian ; Dong, Xiaolin ; Yang, Jing ; Lin, Xiaohong ; Cai, Hanqing ; Song, Weihong ; Li, Xuefeng ; Zhang, Keqin ; Zhang, Qiu ; Lu, Yibing ; Bu, Ruifang ; Shao, Huige ; Wang, Guixia ; Yuan, Guoyue ; Ran, Xingwu ; Liao, Lin ; Zhao, Wenjuan ; Li, Ping ; Sun, Li ; Shi, Lixin ; Jiang, Zhaoshun ; Xue, Yaoming ; Jiang, Hongwei ; Li, Quanmin ; Li, Zongbao ; Fu, Maoxiong ; Liang, Zerong ; Guo, Lian ; Liu, Ming ; Xu, Chun ; Li, Wenhui ; Yu, Xuefeng ; Qin, Guijun ; Yang, Zhou ; Su, Benli ; Zeng, Longyi ; Geng, Houfa ; Shi, Yongquan ; Zhao, Yu ; Zhang, Yi ; Yang, Wenying ; Chen, Li</creatorcontrib><description>Improving glucose sensitivity remains an unmet medical need in treating type 2 diabetes (T2D). Dorzagliatin is a dual-acting, orally bioavailable glucokinase activator that enhances glucokinase activity in a glucose-dependent manner, improves glucose-stimulated insulin secretion and demonstrates effects on glycemic control in patients with T2D. We report the findings of a randomized, double-blind, placebo-controlled phase 3 clinical trial to evaluate the efficacy and safety of dorzagliatin in patients with T2D. Eligible drug-naïve patients with T2D (
n
= 463) were randomly assigned to the dorzagliatin or placebo group at a ratio of 2:1 for 24 weeks of double-blind treatment, followed by 28 weeks of open-label treatment with dorzagliatin for all patients. The primary efficacy endpoint was the change in glycated hemoglobin from baseline to week 24. Safety was assessed throughout the trial. At week 24, the least-squares mean change in glycated hemoglobin from baseline (95% confidence interval) was −1.07% (−1.19%, −0.95%) in the dorzagliatin group and −0.50% (−0.68%, −0.32%) in the placebo group (estimated treatment difference, −0.57%; 95% confidence interval: −0.79%, −0.36%;
P
< 0.001). The incidence of adverse events was similar between the two groups. There were no severe hypoglycemia events or drug-related serious adverse events in the dorzagliatin group. In summary, dorzagliatin improved glycemic control in drug-naïve patients with T2D and showed a good tolerability and safety profile.
The SEED study is a phase 3 clinical trial demonstrating a beneficial effect on glycemic control of dorzagliatin, a glucokinase activator, in drug-naive patients with newly diagnosed type 2 diabetes.</description><identifier>ISSN: 1078-8956</identifier><identifier>EISSN: 1546-170X</identifier><identifier>DOI: 10.1038/s41591-022-01802-6</identifier><identifier>PMID: 35551294</identifier><language>eng</language><publisher>New York: Nature Publishing Group US</publisher><subject>692/163/2743/137/773 ; 692/308/153 ; Adverse events ; Antidiabetics ; Bioavailability ; Biomedical and Life Sciences ; Biomedicine ; Blood Glucose ; Cancer Research ; Clinical trials ; Confidence intervals ; Diabetes ; Diabetes mellitus (non-insulin dependent) ; Diabetes Mellitus, Type 2 - drug therapy ; Double-Blind Method ; Double-blind studies ; Drug Therapy, Combination ; Glucokinase ; Glucose ; Glycated Hemoglobin A - analysis ; Glycated Hemoglobin A - therapeutic use ; Health services ; Hemoglobin ; Humans ; Hypoglycemia ; Hypoglycemic Agents ; Infectious Diseases ; Insulin ; Insulin secretion ; Metabolic Diseases ; Molecular Medicine ; Neurosciences ; Patients ; Placebos ; Pyrazoles ; Safety ; Treatment Outcome</subject><ispartof>Nature medicine, 2022-05, Vol.28 (5), p.965-973</ispartof><rights>The Author(s), under exclusive licence to Springer Nature America, Inc. 2022</rights><rights>2022. The Author(s), under exclusive licence to Springer Nature America, Inc.</rights><rights>Copyright Nature Publishing Group May 2022</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c419t-b9f3c541c647e530ca494b7189c439b59edf28342e0bc9982e677277cef4cf023</citedby><cites>FETCH-LOGICAL-c419t-b9f3c541c647e530ca494b7189c439b59edf28342e0bc9982e677277cef4cf023</cites><orcidid>0000-0002-7997-9404 ; 0000-0002-6192-3752 ; 0000-0001-5245-4379 ; 0000-0003-2243-3336 ; 0000-0002-1064-1261</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://link.springer.com/content/pdf/10.1038/s41591-022-01802-6$$EPDF$$P50$$Gspringer$$H</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1038/s41591-022-01802-6$$EHTML$$P50$$Gspringer$$H</linktohtml><link.rule.ids>314,776,780,27903,27904,41467,42536,51298</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/35551294$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Zhu, Dalong</creatorcontrib><creatorcontrib>Li, Xiaoying</creatorcontrib><creatorcontrib>Ma, Jianhua</creatorcontrib><creatorcontrib>Zeng, Jiao’e</creatorcontrib><creatorcontrib>Gan, Shenglian</creatorcontrib><creatorcontrib>Dong, Xiaolin</creatorcontrib><creatorcontrib>Yang, Jing</creatorcontrib><creatorcontrib>Lin, Xiaohong</creatorcontrib><creatorcontrib>Cai, Hanqing</creatorcontrib><creatorcontrib>Song, Weihong</creatorcontrib><creatorcontrib>Li, Xuefeng</creatorcontrib><creatorcontrib>Zhang, Keqin</creatorcontrib><creatorcontrib>Zhang, Qiu</creatorcontrib><creatorcontrib>Lu, Yibing</creatorcontrib><creatorcontrib>Bu, Ruifang</creatorcontrib><creatorcontrib>Shao, Huige</creatorcontrib><creatorcontrib>Wang, Guixia</creatorcontrib><creatorcontrib>Yuan, Guoyue</creatorcontrib><creatorcontrib>Ran, Xingwu</creatorcontrib><creatorcontrib>Liao, Lin</creatorcontrib><creatorcontrib>Zhao, Wenjuan</creatorcontrib><creatorcontrib>Li, Ping</creatorcontrib><creatorcontrib>Sun, Li</creatorcontrib><creatorcontrib>Shi, Lixin</creatorcontrib><creatorcontrib>Jiang, Zhaoshun</creatorcontrib><creatorcontrib>Xue, Yaoming</creatorcontrib><creatorcontrib>Jiang, Hongwei</creatorcontrib><creatorcontrib>Li, Quanmin</creatorcontrib><creatorcontrib>Li, Zongbao</creatorcontrib><creatorcontrib>Fu, Maoxiong</creatorcontrib><creatorcontrib>Liang, Zerong</creatorcontrib><creatorcontrib>Guo, Lian</creatorcontrib><creatorcontrib>Liu, Ming</creatorcontrib><creatorcontrib>Xu, Chun</creatorcontrib><creatorcontrib>Li, Wenhui</creatorcontrib><creatorcontrib>Yu, Xuefeng</creatorcontrib><creatorcontrib>Qin, Guijun</creatorcontrib><creatorcontrib>Yang, Zhou</creatorcontrib><creatorcontrib>Su, Benli</creatorcontrib><creatorcontrib>Zeng, Longyi</creatorcontrib><creatorcontrib>Geng, Houfa</creatorcontrib><creatorcontrib>Shi, Yongquan</creatorcontrib><creatorcontrib>Zhao, Yu</creatorcontrib><creatorcontrib>Zhang, Yi</creatorcontrib><creatorcontrib>Yang, Wenying</creatorcontrib><creatorcontrib>Chen, Li</creatorcontrib><title>Dorzagliatin in drug-naïve patients with type 2 diabetes: a randomized, double-blind, placebo-controlled phase 3 trial</title><title>Nature medicine</title><addtitle>Nat Med</addtitle><addtitle>Nat Med</addtitle><description>Improving glucose sensitivity remains an unmet medical need in treating type 2 diabetes (T2D). Dorzagliatin is a dual-acting, orally bioavailable glucokinase activator that enhances glucokinase activity in a glucose-dependent manner, improves glucose-stimulated insulin secretion and demonstrates effects on glycemic control in patients with T2D. We report the findings of a randomized, double-blind, placebo-controlled phase 3 clinical trial to evaluate the efficacy and safety of dorzagliatin in patients with T2D. Eligible drug-naïve patients with T2D (
n
= 463) were randomly assigned to the dorzagliatin or placebo group at a ratio of 2:1 for 24 weeks of double-blind treatment, followed by 28 weeks of open-label treatment with dorzagliatin for all patients. The primary efficacy endpoint was the change in glycated hemoglobin from baseline to week 24. Safety was assessed throughout the trial. At week 24, the least-squares mean change in glycated hemoglobin from baseline (95% confidence interval) was −1.07% (−1.19%, −0.95%) in the dorzagliatin group and −0.50% (−0.68%, −0.32%) in the placebo group (estimated treatment difference, −0.57%; 95% confidence interval: −0.79%, −0.36%;
P
< 0.001). The incidence of adverse events was similar between the two groups. There were no severe hypoglycemia events or drug-related serious adverse events in the dorzagliatin group. In summary, dorzagliatin improved glycemic control in drug-naïve patients with T2D and showed a good tolerability and safety profile.
The SEED study is a phase 3 clinical trial demonstrating a beneficial effect on glycemic control of dorzagliatin, a glucokinase activator, in drug-naive patients with newly diagnosed type 2 diabetes.</description><subject>692/163/2743/137/773</subject><subject>692/308/153</subject><subject>Adverse events</subject><subject>Antidiabetics</subject><subject>Bioavailability</subject><subject>Biomedical and Life Sciences</subject><subject>Biomedicine</subject><subject>Blood Glucose</subject><subject>Cancer Research</subject><subject>Clinical trials</subject><subject>Confidence intervals</subject><subject>Diabetes</subject><subject>Diabetes mellitus (non-insulin dependent)</subject><subject>Diabetes Mellitus, Type 2 - drug therapy</subject><subject>Double-Blind Method</subject><subject>Double-blind studies</subject><subject>Drug Therapy, Combination</subject><subject>Glucokinase</subject><subject>Glucose</subject><subject>Glycated Hemoglobin A - analysis</subject><subject>Glycated Hemoglobin A - therapeutic use</subject><subject>Health services</subject><subject>Hemoglobin</subject><subject>Humans</subject><subject>Hypoglycemia</subject><subject>Hypoglycemic Agents</subject><subject>Infectious Diseases</subject><subject>Insulin</subject><subject>Insulin secretion</subject><subject>Metabolic Diseases</subject><subject>Molecular Medicine</subject><subject>Neurosciences</subject><subject>Patients</subject><subject>Placebos</subject><subject>Pyrazoles</subject><subject>Safety</subject><subject>Treatment Outcome</subject><issn>1078-8956</issn><issn>1546-170X</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2022</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>8G5</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AZQEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><sourceid>DWQXO</sourceid><sourceid>GNUQQ</sourceid><sourceid>GUQSH</sourceid><sourceid>M2O</sourceid><recordid>eNp9kc1uFSEYhonR2PboDbgwJG5cFOV3ZnDX1N-kiRtN3BFgvjml4cAIMzbtTXkR3pgcT9XEhQkJfPB8L4QHoSeMvmBUDC-rZEozQjknlA2Uk-4eOmZKdoT19Mv9tqb9QAatuiN0UusVpVRQpR-iI6GUYlzLY3T9Opdbu43BLiHhNsaybkmyP75_Azy3TUhLxddhucTLzQyY4zFYBwvUV9jiYtOYd-EWxlM85tVFIC6G1Ko5Wg8uE5_TUnKMMOL50lbAAi8l2PgIPZhsrPD4bt6gz2_ffDp_Ty4-vvtwfnZBvGR6IU5PwivJfCd7UIJ6K7V0PRu0l0I7pWGc-CAkB-q81gOHru9533uYpJ8oFxv0_JA7l_x1hbqYXageYrQJ8loN71ryIPdfs0HP_kGv8lpSe92e6hgXWspG8QPlS661wGTmEna23BhGzV6LOWgxTYv5pcV0renpXfTqdjD-afntoQHiANR2lLZQ_t79n9ifWt2Yeg</recordid><startdate>20220501</startdate><enddate>20220501</enddate><creator>Zhu, 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in drug-naïve patients with type 2 diabetes: a randomized, double-blind, placebo-controlled phase 3 trial</title><author>Zhu, Dalong ; Li, Xiaoying ; Ma, Jianhua ; Zeng, Jiao’e ; Gan, Shenglian ; Dong, Xiaolin ; Yang, Jing ; Lin, Xiaohong ; Cai, Hanqing ; Song, Weihong ; Li, Xuefeng ; Zhang, Keqin ; Zhang, Qiu ; Lu, Yibing ; Bu, Ruifang ; Shao, Huige ; Wang, Guixia ; Yuan, Guoyue ; Ran, Xingwu ; Liao, Lin ; Zhao, Wenjuan ; Li, Ping ; Sun, Li ; Shi, Lixin ; Jiang, Zhaoshun ; Xue, Yaoming ; Jiang, Hongwei ; Li, Quanmin ; Li, Zongbao ; Fu, Maoxiong ; Liang, Zerong ; Guo, Lian ; Liu, Ming ; Xu, Chun ; Li, Wenhui ; Yu, Xuefeng ; Qin, Guijun ; Yang, Zhou ; Su, Benli ; Zeng, Longyi ; Geng, Houfa ; Shi, Yongquan ; Zhao, Yu ; Zhang, Yi ; Yang, Wenying ; Chen, 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therapeutic use</topic><topic>Health services</topic><topic>Hemoglobin</topic><topic>Humans</topic><topic>Hypoglycemia</topic><topic>Hypoglycemic Agents</topic><topic>Infectious Diseases</topic><topic>Insulin</topic><topic>Insulin secretion</topic><topic>Metabolic Diseases</topic><topic>Molecular Medicine</topic><topic>Neurosciences</topic><topic>Patients</topic><topic>Placebos</topic><topic>Pyrazoles</topic><topic>Safety</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Zhu, Dalong</creatorcontrib><creatorcontrib>Li, Xiaoying</creatorcontrib><creatorcontrib>Ma, Jianhua</creatorcontrib><creatorcontrib>Zeng, Jiao’e</creatorcontrib><creatorcontrib>Gan, Shenglian</creatorcontrib><creatorcontrib>Dong, Xiaolin</creatorcontrib><creatorcontrib>Yang, Jing</creatorcontrib><creatorcontrib>Lin, Xiaohong</creatorcontrib><creatorcontrib>Cai, Hanqing</creatorcontrib><creatorcontrib>Song, 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Edition</collection><collection>ProQuest Central China</collection><collection>ProQuest Central Basic</collection><collection>Genetics Abstracts</collection><collection>MEDLINE - Academic</collection><jtitle>Nature medicine</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Zhu, Dalong</au><au>Li, Xiaoying</au><au>Ma, Jianhua</au><au>Zeng, Jiao’e</au><au>Gan, Shenglian</au><au>Dong, Xiaolin</au><au>Yang, Jing</au><au>Lin, Xiaohong</au><au>Cai, Hanqing</au><au>Song, Weihong</au><au>Li, Xuefeng</au><au>Zhang, Keqin</au><au>Zhang, Qiu</au><au>Lu, Yibing</au><au>Bu, Ruifang</au><au>Shao, Huige</au><au>Wang, Guixia</au><au>Yuan, Guoyue</au><au>Ran, Xingwu</au><au>Liao, Lin</au><au>Zhao, Wenjuan</au><au>Li, Ping</au><au>Sun, Li</au><au>Shi, Lixin</au><au>Jiang, Zhaoshun</au><au>Xue, Yaoming</au><au>Jiang, Hongwei</au><au>Li, Quanmin</au><au>Li, Zongbao</au><au>Fu, Maoxiong</au><au>Liang, Zerong</au><au>Guo, Lian</au><au>Liu, Ming</au><au>Xu, Chun</au><au>Li, Wenhui</au><au>Yu, Xuefeng</au><au>Qin, Guijun</au><au>Yang, Zhou</au><au>Su, Benli</au><au>Zeng, Longyi</au><au>Geng, Houfa</au><au>Shi, Yongquan</au><au>Zhao, Yu</au><au>Zhang, Yi</au><au>Yang, Wenying</au><au>Chen, Li</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Dorzagliatin in drug-naïve patients with type 2 diabetes: a randomized, double-blind, placebo-controlled phase 3 trial</atitle><jtitle>Nature medicine</jtitle><stitle>Nat Med</stitle><addtitle>Nat Med</addtitle><date>2022-05-01</date><risdate>2022</risdate><volume>28</volume><issue>5</issue><spage>965</spage><epage>973</epage><pages>965-973</pages><issn>1078-8956</issn><eissn>1546-170X</eissn><abstract>Improving glucose sensitivity remains an unmet medical need in treating type 2 diabetes (T2D). Dorzagliatin is a dual-acting, orally bioavailable glucokinase activator that enhances glucokinase activity in a glucose-dependent manner, improves glucose-stimulated insulin secretion and demonstrates effects on glycemic control in patients with T2D. We report the findings of a randomized, double-blind, placebo-controlled phase 3 clinical trial to evaluate the efficacy and safety of dorzagliatin in patients with T2D. Eligible drug-naïve patients with T2D (
n
= 463) were randomly assigned to the dorzagliatin or placebo group at a ratio of 2:1 for 24 weeks of double-blind treatment, followed by 28 weeks of open-label treatment with dorzagliatin for all patients. The primary efficacy endpoint was the change in glycated hemoglobin from baseline to week 24. Safety was assessed throughout the trial. At week 24, the least-squares mean change in glycated hemoglobin from baseline (95% confidence interval) was −1.07% (−1.19%, −0.95%) in the dorzagliatin group and −0.50% (−0.68%, −0.32%) in the placebo group (estimated treatment difference, −0.57%; 95% confidence interval: −0.79%, −0.36%;
P
< 0.001). The incidence of adverse events was similar between the two groups. There were no severe hypoglycemia events or drug-related serious adverse events in the dorzagliatin group. In summary, dorzagliatin improved glycemic control in drug-naïve patients with T2D and showed a good tolerability and safety profile.
The SEED study is a phase 3 clinical trial demonstrating a beneficial effect on glycemic control of dorzagliatin, a glucokinase activator, in drug-naive patients with newly diagnosed type 2 diabetes.</abstract><cop>New York</cop><pub>Nature Publishing Group US</pub><pmid>35551294</pmid><doi>10.1038/s41591-022-01802-6</doi><tpages>9</tpages><orcidid>https://orcid.org/0000-0002-7997-9404</orcidid><orcidid>https://orcid.org/0000-0002-6192-3752</orcidid><orcidid>https://orcid.org/0000-0001-5245-4379</orcidid><orcidid>https://orcid.org/0000-0003-2243-3336</orcidid><orcidid>https://orcid.org/0000-0002-1064-1261</orcidid><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 1078-8956 |
| ispartof | Nature medicine, 2022-05, Vol.28 (5), p.965-973 |
| issn | 1078-8956 1546-170X |
| language | eng |
| recordid | cdi_proquest_miscellaneous_2664784000 |
| source | MEDLINE; Nature Journals Online; SpringerLink (Online service) |
| subjects | 692/163/2743/137/773 692/308/153 Adverse events Antidiabetics Bioavailability Biomedical and Life Sciences Biomedicine Blood Glucose Cancer Research Clinical trials Confidence intervals Diabetes Diabetes mellitus (non-insulin dependent) Diabetes Mellitus, Type 2 - drug therapy Double-Blind Method Double-blind studies Drug Therapy, Combination Glucokinase Glucose Glycated Hemoglobin A - analysis Glycated Hemoglobin A - therapeutic use Health services Hemoglobin Humans Hypoglycemia Hypoglycemic Agents Infectious Diseases Insulin Insulin secretion Metabolic Diseases Molecular Medicine Neurosciences Patients Placebos Pyrazoles Safety Treatment Outcome |
| title | Dorzagliatin in drug-naïve patients with type 2 diabetes: a randomized, double-blind, placebo-controlled phase 3 trial |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-01-22T16%3A51%3A11IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_cross&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Dorzagliatin%20in%20drug-na%C3%AFve%20patients%20with%20type%202%20diabetes:%20a%20randomized,%20double-blind,%20placebo-controlled%20phase%203%20trial&rft.jtitle=Nature%20medicine&rft.au=Zhu,%20Dalong&rft.date=2022-05-01&rft.volume=28&rft.issue=5&rft.spage=965&rft.epage=973&rft.pages=965-973&rft.issn=1078-8956&rft.eissn=1546-170X&rft_id=info:doi/10.1038/s41591-022-01802-6&rft_dat=%3Cproquest_cross%3E2666123944%3C/proquest_cross%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=2666123944&rft_id=info:pmid/35551294&rfr_iscdi=true |