Efficacy and safety of cofrogliptin once every 2weeks in Chinese patients with type 2 diabetes: A randomized, double‐blind, placebo‐controlled, phase 3 trial

AimWe conducted a multicentre, randomized phase 3 trial in China to evaluate the efficacy and safety of cofrogliptin (HSK7653), a novel long‐acting dipeptidyl peptidase‐4 inhibitor, in patients with drug‐naïve type 2 diabetes (T2D).Materials and MethodsPatients with inadequately controlled T2D were...

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Published in:Diabetes, obesity & metabolism obesity & metabolism, 2025-01, Vol.27 (1), p.280-290
Main Authors: Gao, Leili, Bian, Fang, Pan, Tianrong, Jiang, Hongwei, Feng, Bo, Jiang, Chengxia, Sun, Jia, Xiao, Jianzhong, Pangke Yan, Ji, Linong
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Language:English
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Clinical trials
Diabetes
Diabetes mellitus (non-insulin dependent)
Hemoglobin
Hyperlipidemia
Hyperuricemia
Placebos
Respiration
Respiratory tract infection
Urinary tract
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container_issue 1
container_start_page 280
container_title Diabetes, obesity & metabolism
container_volume 27
creator Gao, Leili
Bian, Fang
Pan, Tianrong
Jiang, Hongwei
Feng, Bo
Jiang, Chengxia
Sun, Jia
Xiao, Jianzhong
Pangke Yan
Ji, Linong
description AimWe conducted a multicentre, randomized phase 3 trial in China to evaluate the efficacy and safety of cofrogliptin (HSK7653), a novel long‐acting dipeptidyl peptidase‐4 inhibitor, in patients with drug‐naïve type 2 diabetes (T2D).Materials and MethodsPatients with inadequately controlled T2D were randomly assigned (1:1:1) to cofrogliptin 10 mg, cofrogliptin 25 mg or placebo, taken orally once every 2 weeks for a 24‐week double‐blind period. Eligible patients then received cofrogliptin 25 mg in a 28‐week open‐label extension. The primary endpoint was the change in glycated haemoglobin (HbA1c) from baseline to week 24.ResultsIn total, 475 patients (median age: 54.0 years) were randomized and received at least one dose of cofrogliptin 10 mg (n = 158), cofrogliptin 25 mg (n = 158) or placebo (n = 159); 401 patients entered the open‐label extension. At week 24, the least‐squares (LS) mean difference (95% confidence interval [CI]) in HbA1c versus placebo was −0.63% (−0.81, −0.46) with cofrogliptin 10 mg and −0.59% (−0.77, −0.42) with cofrogliptin 25 mg (both p 
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Eligible patients then received cofrogliptin 25 mg in a 28‐week open‐label extension. The primary endpoint was the change in glycated haemoglobin (HbA1c) from baseline to week 24.ResultsIn total, 475 patients (median age: 54.0 years) were randomized and received at least one dose of cofrogliptin 10 mg (n = 158), cofrogliptin 25 mg (n = 158) or placebo (n = 159); 401 patients entered the open‐label extension. At week 24, the least‐squares (LS) mean difference (95% confidence interval [CI]) in HbA1c versus placebo was −0.63% (−0.81, −0.46) with cofrogliptin 10 mg and −0.59% (−0.77, −0.42) with cofrogliptin 25 mg (both p &lt; 0.0001). The LS mean (standard error) change in HbA1c from baseline was maintained at the end of the study in patients given open‐label cofrogliptin 25 mg for an additional 28 weeks: cofrogliptin 10 mg: −0.86% (0.07); cofrogliptin 25 mg: −0.74% (0.07); placebo: −0.89% (0.07). Over the entire study, common adverse events were hyperuricaemia, hyperlipidaemia, hypertriglyceridaemia, increased lipase, upper respiratory tract infection and urinary tract infection. Hypoglycaemic events did not significantly differ between groups.ConclusionsCofrogliptin provided glycaemic control over 52 weeks and was generally well tolerated in patients with T2D.Clinical Trial RegistrationRegistered on Clinicaltrials.gov with the registration number NCT04556851 (https://clinicaltrials.gov/study/NCT04556851).</description><identifier>ISSN: 1462-8902</identifier><identifier>EISSN: 1463-1326</identifier><identifier>DOI: 10.1111/dom.16014</identifier><language>eng</language><publisher>Oxford: Wiley Subscription Services, Inc</publisher><subject>Clinical trials ; Diabetes ; Diabetes mellitus (non-insulin dependent) ; Hemoglobin ; Hyperlipidemia ; Hyperuricemia ; Placebos ; Respiration ; Respiratory tract infection ; Urinary tract</subject><ispartof>Diabetes, obesity &amp; metabolism, 2025-01, Vol.27 (1), p.280-290</ispartof><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><woscitedreferencessubscribed>false</woscitedreferencessubscribed></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,776,780,27901,27902</link.rule.ids></links><search><creatorcontrib>Gao, Leili</creatorcontrib><creatorcontrib>Bian, Fang</creatorcontrib><creatorcontrib>Pan, Tianrong</creatorcontrib><creatorcontrib>Jiang, Hongwei</creatorcontrib><creatorcontrib>Feng, Bo</creatorcontrib><creatorcontrib>Jiang, Chengxia</creatorcontrib><creatorcontrib>Sun, Jia</creatorcontrib><creatorcontrib>Xiao, Jianzhong</creatorcontrib><creatorcontrib>Pangke Yan</creatorcontrib><creatorcontrib>Ji, Linong</creatorcontrib><title>Efficacy and safety of cofrogliptin once every 2weeks in Chinese patients with type 2 diabetes: A randomized, double‐blind, placebo‐controlled, phase 3 trial</title><title>Diabetes, obesity &amp; metabolism</title><description>AimWe conducted a multicentre, randomized phase 3 trial in China to evaluate the efficacy and safety of cofrogliptin (HSK7653), a novel long‐acting dipeptidyl peptidase‐4 inhibitor, in patients with drug‐naïve type 2 diabetes (T2D).Materials and MethodsPatients with inadequately controlled T2D were randomly assigned (1:1:1) to cofrogliptin 10 mg, cofrogliptin 25 mg or placebo, taken orally once every 2 weeks for a 24‐week double‐blind period. Eligible patients then received cofrogliptin 25 mg in a 28‐week open‐label extension. The primary endpoint was the change in glycated haemoglobin (HbA1c) from baseline to week 24.ResultsIn total, 475 patients (median age: 54.0 years) were randomized and received at least one dose of cofrogliptin 10 mg (n = 158), cofrogliptin 25 mg (n = 158) or placebo (n = 159); 401 patients entered the open‐label extension. At week 24, the least‐squares (LS) mean difference (95% confidence interval [CI]) in HbA1c versus placebo was −0.63% (−0.81, −0.46) with cofrogliptin 10 mg and −0.59% (−0.77, −0.42) with cofrogliptin 25 mg (both p &lt; 0.0001). The LS mean (standard error) change in HbA1c from baseline was maintained at the end of the study in patients given open‐label cofrogliptin 25 mg for an additional 28 weeks: cofrogliptin 10 mg: −0.86% (0.07); cofrogliptin 25 mg: −0.74% (0.07); placebo: −0.89% (0.07). Over the entire study, common adverse events were hyperuricaemia, hyperlipidaemia, hypertriglyceridaemia, increased lipase, upper respiratory tract infection and urinary tract infection. Hypoglycaemic events did not significantly differ between groups.ConclusionsCofrogliptin provided glycaemic control over 52 weeks and was generally well tolerated in patients with T2D.Clinical Trial RegistrationRegistered on Clinicaltrials.gov with the registration number NCT04556851 (https://clinicaltrials.gov/study/NCT04556851).</description><subject>Clinical trials</subject><subject>Diabetes</subject><subject>Diabetes mellitus (non-insulin dependent)</subject><subject>Hemoglobin</subject><subject>Hyperlipidemia</subject><subject>Hyperuricemia</subject><subject>Placebos</subject><subject>Respiration</subject><subject>Respiratory tract infection</subject><subject>Urinary tract</subject><issn>1462-8902</issn><issn>1463-1326</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2025</creationdate><recordtype>article</recordtype><recordid>eNqNTEtOwzAUtBBIlM-CGzyJLS12HCUNO1QV9QDsK8d5Ji6uX7AdqrDiCFyBq3ESDOIAzGa-GsauBF-IjNuO9gtRcVEesZkoKzkXsqiOf3UxXza8OGVnMe4456Vc1jP2uTbGaqUnUL6DqAymCciAJhPoydkhWQ_kNQK-YpigOCA-R8jhqrceI8KgkkWfIhxs6iFNA0IBnVUtJox3cA8hP9PevmF3Ax2NrcOv94_WWZ_94JTGlnKgyadAzv2shl7lYwkpWOUu2IlRLuLlH5-z64f142ozHwK9jBjTdkdj8LnaSlHyWjRVU8v_rb4BwJNjLw</recordid><startdate>20250101</startdate><enddate>20250101</enddate><creator>Gao, Leili</creator><creator>Bian, Fang</creator><creator>Pan, Tianrong</creator><creator>Jiang, Hongwei</creator><creator>Feng, Bo</creator><creator>Jiang, Chengxia</creator><creator>Sun, Jia</creator><creator>Xiao, Jianzhong</creator><creator>Pangke Yan</creator><creator>Ji, Linong</creator><general>Wiley Subscription Services, Inc</general><scope>7T5</scope><scope>7TK</scope><scope>H94</scope><scope>K9.</scope></search><sort><creationdate>20250101</creationdate><title>Efficacy and safety of cofrogliptin once every 2weeks in Chinese patients with type 2 diabetes: A randomized, double‐blind, placebo‐controlled, phase 3 trial</title><author>Gao, Leili ; Bian, Fang ; Pan, Tianrong ; Jiang, Hongwei ; Feng, Bo ; Jiang, Chengxia ; Sun, Jia ; Xiao, Jianzhong ; Pangke Yan ; Ji, Linong</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-proquest_journals_31407196973</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2025</creationdate><topic>Clinical trials</topic><topic>Diabetes</topic><topic>Diabetes mellitus (non-insulin dependent)</topic><topic>Hemoglobin</topic><topic>Hyperlipidemia</topic><topic>Hyperuricemia</topic><topic>Placebos</topic><topic>Respiration</topic><topic>Respiratory tract infection</topic><topic>Urinary tract</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Gao, Leili</creatorcontrib><creatorcontrib>Bian, Fang</creatorcontrib><creatorcontrib>Pan, Tianrong</creatorcontrib><creatorcontrib>Jiang, Hongwei</creatorcontrib><creatorcontrib>Feng, Bo</creatorcontrib><creatorcontrib>Jiang, Chengxia</creatorcontrib><creatorcontrib>Sun, Jia</creatorcontrib><creatorcontrib>Xiao, Jianzhong</creatorcontrib><creatorcontrib>Pangke Yan</creatorcontrib><creatorcontrib>Ji, Linong</creatorcontrib><collection>Immunology Abstracts</collection><collection>Neurosciences Abstracts</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health &amp; Medical Complete (Alumni)</collection><jtitle>Diabetes, obesity &amp; metabolism</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Gao, Leili</au><au>Bian, Fang</au><au>Pan, Tianrong</au><au>Jiang, Hongwei</au><au>Feng, Bo</au><au>Jiang, Chengxia</au><au>Sun, Jia</au><au>Xiao, Jianzhong</au><au>Pangke Yan</au><au>Ji, Linong</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Efficacy and safety of cofrogliptin once every 2weeks in Chinese patients with type 2 diabetes: A randomized, double‐blind, placebo‐controlled, phase 3 trial</atitle><jtitle>Diabetes, obesity &amp; metabolism</jtitle><date>2025-01-01</date><risdate>2025</risdate><volume>27</volume><issue>1</issue><spage>280</spage><epage>290</epage><pages>280-290</pages><issn>1462-8902</issn><eissn>1463-1326</eissn><abstract>AimWe conducted a multicentre, randomized phase 3 trial in China to evaluate the efficacy and safety of cofrogliptin (HSK7653), a novel long‐acting dipeptidyl peptidase‐4 inhibitor, in patients with drug‐naïve type 2 diabetes (T2D).Materials and MethodsPatients with inadequately controlled T2D were randomly assigned (1:1:1) to cofrogliptin 10 mg, cofrogliptin 25 mg or placebo, taken orally once every 2 weeks for a 24‐week double‐blind period. Eligible patients then received cofrogliptin 25 mg in a 28‐week open‐label extension. The primary endpoint was the change in glycated haemoglobin (HbA1c) from baseline to week 24.ResultsIn total, 475 patients (median age: 54.0 years) were randomized and received at least one dose of cofrogliptin 10 mg (n = 158), cofrogliptin 25 mg (n = 158) or placebo (n = 159); 401 patients entered the open‐label extension. At week 24, the least‐squares (LS) mean difference (95% confidence interval [CI]) in HbA1c versus placebo was −0.63% (−0.81, −0.46) with cofrogliptin 10 mg and −0.59% (−0.77, −0.42) with cofrogliptin 25 mg (both p &lt; 0.0001). The LS mean (standard error) change in HbA1c from baseline was maintained at the end of the study in patients given open‐label cofrogliptin 25 mg for an additional 28 weeks: cofrogliptin 10 mg: −0.86% (0.07); cofrogliptin 25 mg: −0.74% (0.07); placebo: −0.89% (0.07). Over the entire study, common adverse events were hyperuricaemia, hyperlipidaemia, hypertriglyceridaemia, increased lipase, upper respiratory tract infection and urinary tract infection. Hypoglycaemic events did not significantly differ between groups.ConclusionsCofrogliptin provided glycaemic control over 52 weeks and was generally well tolerated in patients with T2D.Clinical Trial RegistrationRegistered on Clinicaltrials.gov with the registration number NCT04556851 (https://clinicaltrials.gov/study/NCT04556851).</abstract><cop>Oxford</cop><pub>Wiley Subscription Services, Inc</pub><doi>10.1111/dom.16014</doi></addata></record>
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subjects Clinical trials
Diabetes
Diabetes mellitus (non-insulin dependent)
Hemoglobin
Hyperlipidemia
Hyperuricemia
Placebos
Respiration
Respiratory tract infection
Urinary tract
title Efficacy and safety of cofrogliptin once every 2weeks in Chinese patients with type 2 diabetes: A randomized, double‐blind, placebo‐controlled, phase 3 trial
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