Ignite Creation Date:
2025-12-25 @ 3:53 AM
Ignite Modification Date:
2025-12-26 @ 2:42 AM
Study NCT ID:
NCT07122102
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-26
First Post:
2025-08-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
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
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020909', 'term': 'Acarbose'}], 'ancestors': [{'id': 'D014312', 'term': 'Trisaccharides'}, {'id': 'D009844', 'term': 'Oligosaccharides'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2027-07-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-23', 'studyFirstSubmitDate': '2025-08-07', 'studyFirstSubmitQcDate': '2025-08-07', 'lastUpdatePostDateStruct': {'date': '2025-09-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-08-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HbA1c', 'timeFrame': 'From enrollment to the end of treatment at 12 weeks', 'description': 'The difference in HbA1c from the baseline'}], 'secondaryOutcomes': [{'measure': 'FPG (Fasting plasma glucose)', 'timeFrame': 'From enrollment to the end of treatment at 12 weeks', 'description': 'The difference in FPG from the baseline'}, {'measure': '2h-PPG (2-hour postprandial glucose)', 'timeFrame': 'From enrollment to the end of treatment at 12 weeks', 'description': 'The difference in 2h-PPG from the baseline'}, {'measure': 'Fasting C-peptide', 'timeFrame': 'From enrollment to the end of treatment at 12 weeks', 'description': 'The difference in fasting C-peptide from the baseline'}, {'measure': 'Insulin sensitivity', 'timeFrame': 'From enrollment to the end of treatment at 12 weeks', 'description': 'The difference in insulin sensitivity from the baseline'}, {'measure': 'Islet function', 'timeFrame': 'From enrollment to the end of treatment at 12 weeks', 'description': 'The difference in Islet function from the baseline'}, {'measure': 'Body weight', 'timeFrame': 'From enrollment to the end of treatment at 12 weeks', 'description': 'The difference in body weight from the baseline'}, {'measure': 'Intestinal microbial composition and functional characteristics', 'timeFrame': 'From enrollment to the end of treatment at 12 weeks', 'description': 'The difference in intestinal microbial composition and functional characteristics from the baseline'}, {'measure': 'Incidence of hypoglycemia', 'timeFrame': 'From enrollment to the end of safety visitation at 13 weeks', 'description': 'The percentage of subjects who experienced any investigator-defined hypoglycemic adverse event'}, {'measure': 'Gastrointestinal adverse events', 'timeFrame': 'From enrollment to the end of safety visitation at 13 weeks', 'description': 'The percentage of subjects who experienced any investigator-defined gastrointestinal adverse events adverse event'}, {'measure': 'Other adverse events', 'timeFrame': 'From enrollment to the end of safety visitation at 13 weeks', 'description': 'The percentage of subjects who experienced any investigator-defined adverse event'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cofrogliptin', 'acarbose', 'type 2 diabetes'], 'conditions': ['Type 2 Diabetes']}, 'descriptionModule': {'briefSummary': 'This study will compare the effect and safety of cofrogliptin (HSK7653) with acarbose among people with type 2 diabetes', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '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/L. 7.Body mass index (BMI) at randomization: 18 ≤ BMI ≤ 35 kg/m². 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/β-cell transplantation, or diabetes secondary to pancreatitis/pancreatectomy.\n\n 3.Acute coronary syndrome (STEMI/NSTEMI/unstable 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 \\<25 mL/min/1.73m²). 8.Chronic gastrointestinal disorders with significant malabsorption. 9.Conditions potentially aggravated by intestinal gas (e.g., Roemheld syndrome, severe hernia, intestinal obstruction/ulceration).\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/or active cancer therapy.\n\n 13.HIV infection. 14.Severe peripheral vascular disease. 15.Hematological disorders causing hemolysis/erythrocyte 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/males).\n\n 19.Participation in other clinical trials within 30 days prior to screening. 20.Any other condition deemed unsuitable by the investigator.'}, 'identificationModule': {'nctId': 'NCT07122102', 'acronym': 'CARAT', 'briefTitle': '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', 'organization': {'class': 'INDUSTRY', 'fullName': 'Haisco Pharmaceutical Group Co., Ltd.'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'HSK7653-503'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cofrogliptin （HSK7653）', 'description': 'Cofrogliptin tablets,10mg administered once every two weeks', 'interventionNames': ['Drug: Cofrogliptin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Acarbose', 'description': 'Acarbose tablets, 50mg administered three times daily', 'interventionNames': ['Drug: Acarbose']}], 'interventions': [{'name': 'Cofrogliptin', 'type': 'DRUG', 'description': '10mg administered once every two weeks', 'armGroupLabels': ['Cofrogliptin （HSK7653）']}, {'name': 'Acarbose', 'type': 'DRUG', 'description': '50mg administered 3 times daily', 'armGroupLabels': ['Acarbose']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Zhengzhou', 'state': 'Henan', 'country': 'China', 'contacts': [{'name': 'Xiaoyang Shi', 'role': 'CONTACT', 'email': 'ashi_1985@163.com', 'phoneExt': '+8615803837715'}], 'facility': "He'nan Provincial People's Hospital", 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}], 'centralContacts': [{'name': 'Fangqiong Li', 'role': 'CONTACT', 'email': 'lifangq@haisco.com', 'phone': '+86 028-67258'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Haisco Pharmaceutical Group Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}