[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100602330":3},{"organization":4,"outcomesModule":7,"designInfo":46,"detailedDescription":52,"studyPopulation":45,"armGroups":53,"interventions":66,"overallOfficials":45,"centralContacts":75,"locations":81,"responsibleParty":99,"collaborators":45,"id":101,"slug":45,"hasResults":102,"nctId":103,"briefTitle":104,"officialTitle":104,"acronym":105,"eligibilityCriteria":106,"healthyVolunteers":102,"sex":107,"minAge":108,"maxAge":45,"enrollmentInfo":109,"targetDuration":45,"studyType":112,"phases":113,"briefSummary":115,"conditions":116,"keywords":118,"overallStatus":122,"whyStopped":45,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":132},{"fullName":5,"class":6},"Haisco Pharmaceutical Group Co., Ltd.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":45},[9],{"measure":10,"description":11,"timeFrame":12},"HbA1c","The difference in HbA1c from the baseline","From enrollment to the end of treatment at 12 weeks",[14,17,20,23,26,29,32,35,39,42],{"measure":15,"description":16,"timeFrame":12},"FPG (Fasting plasma glucose)","The difference in FPG from the baseline",{"measure":18,"description":19,"timeFrame":12},"2h-PPG (2-hour postprandial glucose)","The difference in 2h-PPG from the baseline",{"measure":21,"description":22,"timeFrame":12},"Fasting C-peptide","The difference in fasting C-peptide from the baseline",{"measure":24,"description":25,"timeFrame":12},"Insulin sensitivity","The difference in insulin sensitivity from the baseline",{"measure":27,"description":28,"timeFrame":12},"Islet function","The difference in Islet function from the baseline",{"measure":30,"description":31,"timeFrame":12},"Body weight","The difference in body weight from the baseline",{"measure":33,"description":34,"timeFrame":12},"Intestinal microbial composition and functional characteristics","The difference in intestinal microbial composition and functional characteristics from the baseline",{"measure":36,"description":37,"timeFrame":38},"Incidence of hypoglycemia","The percentage of subjects who experienced any investigator-defined hypoglycemic adverse event","From enrollment to the end of safety visitation at 13 weeks",{"measure":40,"description":41,"timeFrame":38},"Gastrointestinal adverse events","The percentage of subjects who experienced any investigator-defined gastrointestinal adverse events adverse event",{"measure":43,"description":44,"timeFrame":38},"Other adverse events","The percentage of subjects who experienced any investigator-defined adverse event",null,{"allocation":47,"interventionModel":48,"interventionModelDescription":45,"primaryPurpose":49,"observationalModel":45,"timePerspective":45,"maskingInfo":50},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":51,"maskingDescription":45,"whoMasked":45},"NONE","This study will enroll treatment-naïve patients with type 2 diabetes who meet inclusion criteria, and randomize them 1:1 to either the coglitin treatment group or the acarbose treatment group for a 12-week open-label parallel-controlled treatment period, with the coglitin group receiving 10mg coglitin tablets once every two weeks and the acarbose group receiving 50mg acarbose tablets three times daily; the primary endpoint is the change in glycated hemoglobin (HbA1c) from baseline at week 12, followed by a 1-week safety follow-up visit after treatment completion, with study conclusion upon completion of this safety visit.",[54,60],{"label":55,"type":56,"description":57,"interventionNames":58},"Cofrogliptin （HSK7653）","EXPERIMENTAL","Cofrogliptin tablets,10mg administered once every two weeks",[59],"Drug: Cofrogliptin",{"label":61,"type":62,"description":63,"interventionNames":64},"Acarbose","ACTIVE_COMPARATOR","Acarbose tablets, 50mg administered three times daily",[65],"Drug: Acarbose",[67,72],{"type":68,"name":69,"description":70,"armGroupLabels":71,"otherNames":45},"DRUG","Cofrogliptin","10mg administered once every two weeks",[55],{"type":68,"name":61,"description":73,"armGroupLabels":74,"otherNames":45},"50mg administered 3 times daily",[61],[76],{"name":77,"role":78,"phone":79,"phoneExt":45,"email":80},"Fangqiong Li","CONTACT","+86 028-67258","lifangq@haisco.com",[82],{"facility":83,"status":45,"city":84,"state":85,"zip":45,"country":86,"countryCode":87,"cosmosGeoPoint":88,"geoPoint":93,"contacts":94},"He'nan Provincial People's Hospital","Zhengzhou","Henan","China","CN",{"type":89,"coordinates":90},"Point",[91,92],113.64861,34.75778,{"lat":92,"lon":91},[95],{"name":96,"role":78,"phone":45,"phoneExt":97,"email":98},"Xiaoyang Shi","+8615803837715","ashi_1985@163.com",{"type":100,"investigatorFullName":45,"investigatorTitle":45,"investigatorAffiliation":45,"oldNameTitle":45,"oldOrganization":45},"SPONSOR","100602330",false,"NCT07122102","A Multicenter, Randomized, Open-Label, Parallel-Controlled Clinical Study Comparing the Efficacy and Safety of Cofrogliptin Versus Acarbose in Drug-Naïve Patients With Type 2 Diabetes","CARAT","Inclusion Criteria:\n\n* 1.Capable of understanding and voluntarily signing the written informed consent form.\n\n  2.Male or female aged ≥18 years (inclusive). 3.Fulfills diagnostic criteria for type 2 diabetes mellitus. 4.Previous glycemic control managed exclusively through diet and exercise therapy, with no prior exposure to any glucose-lowering or diabetes-related medications.\n\n  5.HbA1c at randomization: 7.0% ≤ HbA1c ≤ 9.0%. 6.Fasting plasma glucose (FPG) at randomization: FPG ≤ 11 mmol\u002FL. 7.Body mass index (BMI) at randomization: 18 ≤ BMI ≤ 35 kg\u002Fm². 8.Agrees to maintain consistent dietary and exercise habits throughout the trial period.\n\nExclusion Criteria:\n\n* 1.Known hypersensitivity to any component of the investigational product, chemically related compounds, or excipients.\n\n  2.History of diabetic ketoacidosis, type 1 diabetes, pancreatic\u002Fβ-cell transplantation, or diabetes secondary to pancreatitis\u002Fpancreatectomy.\n\n  3.Acute coronary syndrome (STEMI\u002FNSTEMI\u002Funstable angina), stroke, or transient ischemic attack (TIA) within 3 months prior to informed consent.\n\n  4.Congestive heart failure (NYHA Class III-IV). 5.Uncontrolled hypertension (systolic BP ≥180 mmHg or diastolic BP ≥110 mmHg). 6.Hepatic impairment: ALT, AST, or ALP \\>3×ULN at screening. 7.Severe renal impairment (eGFR \\\u003C25 mL\u002Fmin\u002F1.73m²). 8.Chronic gastrointestinal disorders with significant malabsorption. 9.Conditions potentially aggravated by intestinal gas (e.g., Roemheld syndrome, severe hernia, intestinal obstruction\u002Fulceration).\n\n  10.Bariatric surgery or malabsorptive gastrointestinal procedures within past 2 years.\n\n  11.Anti-obesity medications within 3 months prior to consent or weight instability at screening.\n\n  12.Malignancy (except basal cell carcinoma) within 5 years and\u002For active cancer therapy.\n\n  13.HIV infection. 14.Severe peripheral vascular disease. 15.Hematological disorders causing hemolysis\u002Ferythrocyte instability (e.g., malaria, babesiosis, hemolytic anemia).\n\n  16.Current systemic corticosteroid use, thyroid hormone dose changes within 6 weeks, or uncontrolled endocrine disorders (excluding T2DM).\n\n  17.Substance abuse within 3 months or chronic conditions potentially compromising compliance.\n\n  18.Pregnancy, lactation, or unwillingness to use effective contraception (females\u002Fmales).\n\n  19.Participation in other clinical trials within 30 days prior to screening. 20.Any other condition deemed unsuitable by the investigator.","ALL","18 Years",{"count":110,"type":111},200,"ESTIMATED","INTERVENTIONAL",[114],"NA","This study will compare the effect and safety of cofrogliptin (HSK7653) with acarbose among people with type 2 diabetes",[117],"Type 2 Diabetes",[119,120,121],"cofrogliptin","acarbose","type 2 diabetes","NOT_YET_RECRUITING","2025-09-23",{"date":125,"type":126},"2025-09-26","ACTUAL",{"date":128,"type":111},"2025-10-01",{"date":130,"type":111},"2027-07-30",{"name":5,"class":6},1]