Ignite Creation Date:
2025-12-24 @ 10:01 PM
Ignite Modification Date:
2025-12-25 @ 7:38 PM
Study NCT ID:
NCT07198932
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-30
First Post:
2025-09-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cofrogliptin and Linagliptin as add-on Therapy to Insulin in Type 2 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D007333', 'term': 'Insulin Resistance'}], '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'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 594}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-28', 'studyFirstSubmitDate': '2025-09-19', 'studyFirstSubmitQcDate': '2025-09-28', 'lastUpdatePostDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Diabetes Treatment Satisfaction Questionnaire status (DTSQs)', 'timeFrame': 'at baseline, 12 weeks and 24 weeks', 'description': 'questionnaire scores'}, {'measure': 'Short-Form 36 Health Survey (SF-36)', 'timeFrame': 'at baseline, 12 weeks and 24 weeks', 'description': 'questionnaire scores'}, {'measure': 'Drug adherence', 'timeFrame': 'at 24 weeks', 'description': 'measured by pill counts'}, {'measure': 'Drug persistence', 'timeFrame': 'at 24 weeks', 'description': 'defined as the proportion of patients who continued to use their index medications'}], 'primaryOutcomes': [{'measure': 'Change in HbA1c', 'timeFrame': 'from baseline to 24 weeks'}], 'secondaryOutcomes': [{'measure': 'Change in HbA1c', 'timeFrame': 'from baseline to 12 weeks'}, {'measure': 'Reaching of HbA1c target (defined as HbA1c less than 7%)', 'timeFrame': 'at 24 weeks', 'description': 'Percentage point'}, {'measure': 'Change in FPG', 'timeFrame': 'from baseline to 24 weeks', 'description': 'mmol/L'}, {'measure': 'Change in PPG', 'timeFrame': 'from baseline to 24 weeks', 'description': 'mmol/L'}, {'measure': 'Change in fasting C peptide', 'timeFrame': 'from baseline to 24 weeks', 'description': 'ng/mL'}, {'measure': 'Change in body weight', 'timeFrame': 'from baseline to 24 weeks', 'description': 'Kg'}, {'measure': 'Change in insulin dose', 'timeFrame': 'from baseline to 24 weeks', 'description': 'units/day'}, {'measure': 'Overall safety, consisting of adverse events (AEs), serious adverse events (SAEs), adverse events of special interest', 'timeFrame': 'from baseline to 24 weeks'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['real-world study', 'cofrogliptin', 'DPP-4i', 'insulin'], 'conditions': ['Type 2 Diabetes']}, 'descriptionModule': {'briefSummary': 'This study is a multicenter, prospective, non-interventional real-world study to evaluate the clinical outcomes of biweekly cofrogliptin versus daily linagliptin as an add-on therapy in Chinese adult T2D patients.', 'detailedDescription': "About 43 hospitals from different parts of China will take part in this study. Patients aged ≥18 years who have been previously treated with a stable dose of insulin and no more than three classes of oral antidiabetic drugs (OADs) for at least 12 weeks without adequate glycemic control will be enrolled and assigned to either cofrogliptin once every 2 weeks cohort or linagliptin once-daily cohort based on the prescription. Initiation of cofrogliptin or linagliptin treatment was at the treating physician's discretion.\n\nEnrolled participants will undergo routine follow-up for up to 24 weeks. During the follow-up period, data will be collected from face-to-face participant-investigator visits at the beginning of the study (0 weeks, visit 1), early stage (4 weeks, visit 2), mid-stage (12 weeks, visit 3) and at the end of the study (24 weeks, visit 4). Data sources include patient medical records, diaries, self-monitoring of blood glucose (SMBG), and questionnaires. No additional diagnostics, monitoring procedures, or interventions outside of usual clinical practice will be applied to the participants. The project will probably last for about 24 months."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Real-world adult population with type 2 diabetes in China.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Sign the informed consent form.\n2. Aged ≥18 years.\n3. Diagnosed with type 2 diabetes mellitus (meeting the 1999 WHO diagnostic criteria).\n4. Recently tested HbA1c 7%-9% and FPG ≤11 mmol/L, with stable treatment using insulin ± OADs for at least 12 weeks prior to enrollment. Insulin regimens are limited to: basal insulin once daily or once weekly, premixed insulin once or twice daily, or IDegAsp once or twice daily. OAD classes are limited to metformin, SGLT2 inhibitors, and α-glucosidase inhibitors and with no more than three agents in total.\n5. Willing to start or have already initiated cofrogliptin or linagliptin treatment (at the physician's discretion in accordance with clinical practice). The treatment decision is independent of study enrollment, must be made before signing the informed consent, and cofrogliptin or linagliptin initiation must occur either within 2 weeks before or within 2 weeks after signing the informed consent.\n\nExclusion Criteria:\n\n1. Allergic to the study drug.\n2. Diagnosed with type 1 diabetes.\n3. Unable to comply with study-specific procedures.\n4. Current or planned pregnant, or currently breastfeeding.\n5. With any other situation judged by the investigator, that is unsuitable for participation in this trial."}, 'identificationModule': {'nctId': 'NCT07198932', 'acronym': 'COLOR-REAL', 'briefTitle': 'Cofrogliptin and Linagliptin as add-on Therapy to Insulin in Type 2 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-sen University'}, 'officialTitle': 'Effectiveness and Safety of Cofrogliptin and Linagliptin as add-on Therapy to Insulin in Chinese Adults With Type 2 Diabetes Mellitus: a Multicenter, Prospective Real-world Study (COLOR-REAL)', 'orgStudyIdInfo': {'id': 'IIT-2025-340'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cofrogliptin cohort', 'interventionNames': ['Drug: Cofrogliptin add to insulin']}, {'label': 'Linagliptin cohort', 'interventionNames': ['Drug: Linagliptin add to insulin']}], 'interventions': [{'name': 'Cofrogliptin add to insulin', 'type': 'DRUG', 'description': 'Patients will be treated with commercially available cofrogliptin according to routine clinical practice at the discretion of the treating physician.', 'armGroupLabels': ['Cofrogliptin cohort']}, {'name': 'Linagliptin add to insulin', 'type': 'DRUG', 'description': 'Patients will be treated with commercially available linagliptin according to routine clinical practice at the discretion of the treating physician.', 'armGroupLabels': ['Linagliptin cohort']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'city': 'Baoding', 'country': 'China', 'facility': 'Affiliated Hospital of Hebei University', 'geoPoint': {'lat': 38.87288, 'lon': 115.46246}}, {'city': 'Beijing', 'country': 'China', 'facility': 'Beijing Luhe Hospital Affiliated to Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'country': 'China', 'facility': 'the First Medical Center of Chinese PLA General Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Shanghai', 'country': 'China', 'facility': 'Qingpu Branch of Zhongshan Hospital Affiliated to Fudan University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Shanghai', 'country': 'China', 'facility': 'Shanghai Changzheng Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': "Xi'an", 'country': 'China', 'facility': "Xi'an International Medical Center Hospital", 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yanbing Li', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'First Affiliated Hospital, Sun Yat-Sen University', 'investigatorFullName': 'Yanbing Li', 'investigatorAffiliation': 'Sun Yat-sen University'}}}}