Ignite Creation Date:
2025-12-24 @ 5:25 PM
Ignite Modification Date:
2026-01-02 @ 8:14 AM
Study NCT ID:
NCT07026968
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-09-29
First Post:
2025-06-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Prusogliptin Tablets Combined With Dapagliflozin Tablets and Metformin Hydrochloride Extended Release Tablets 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'}], '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': 'C529054', 'term': 'dapagliflozin'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Multicenter, Randomized, Double-blind, Parallel-controlled'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 815}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2025-06-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2026-11-13', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-25', 'studyFirstSubmitDate': '2025-06-10', 'studyFirstSubmitQcDate': '2025-06-10', 'lastUpdatePostDateStruct': {'date': '2025-09-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-06-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-10-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean change from baseline in HbA1c at Week 24', 'timeFrame': 'From baseline to week 24'}], 'secondaryOutcomes': [{'measure': 'Proportion of participants with HbA1c of ≤6.5% and HbA1c of ≤7% at week 24', 'timeFrame': 'From baseline to week 24'}, {'measure': 'Relative change from baseline in HbA1c at week 12', 'timeFrame': 'From baseline to week 12'}, {'measure': 'Relative change from baseline in FPG at week 12 and week 24', 'timeFrame': 'From baseline to week 12 and week 24'}, {'measure': 'Relative change from baseline in 2h-PPG at week 12 and week 24', 'timeFrame': 'From baseline to week 12 and week 24'}, {'measure': 'Relative change from baseline in weight at week 12 and week 24', 'timeFrame': 'From baseline to week 12 and week 24'}, {'measure': 'Relative change from baseline in blood pressure at week 12 and week 24', 'timeFrame': 'From baseline to week 12 and week 24'}, {'measure': 'Relative change from baseline in blood lipid level at week 12 and week 24', 'timeFrame': 'From baseline to week 12 and week 24'}, {'measure': 'Relative change from baseline in 7-point blood glucose levels and average post-meal blood glucose increments at week 24', 'timeFrame': 'From baseline to week 24'}, {'measure': 'Proportion of participants who received rescue treatment after 24 weeks of treatment', 'timeFrame': 'From baseline to week 24'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Type 2 Diabetes']}, 'descriptionModule': {'briefSummary': 'This study is a multicenter, randomized, double-blind, parallel-controlled, phase III clinical trial to evaluate efficacy and safety of the triple combination therapy of prusogliptin, dapagliflozin and metformin in subjects with type 2 diabetes who have inadequate glycemic control on metformin alone.', 'detailedDescription': 'Avoid duplicating information that will be entered elsewhere, such as Eligibility Criteria or Outcome Measures.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects with type 2 diabetes was confirmed at least 10 weeks prior to the screening;\n* Male or female, 18 years ≤ age ≤ 75 years;\n* Body Mass Index (BMI) ≥ 18.5 kg/m\\^2, and ≤40 kg/m\\^2;\n* Stable metformin therapy for at least 10 weeks prior to screening at a dose ≥ 1500 mg per day;\n* The glycated hemoglobin must meet the following standards:During screening: 7.5% ≤ HbA1c ≤ 11.0% (local laboratory);Before random sampling: 7.0% ≤ HbA1c ≤ 10.5% (central laboratory);\n* Be able to understand and follow the test procedures, voluntarily participate in the test and sign the ICF.\n\nExclusion Criteria:\n\n* Type 1 diabetes or other special types of diabetes;\n* ≥2 episodes of Grade 3 hypoglycemia within 6 months prior to screening, or any Grade 3 hypoglycemia occurring from screening to randomization;\n* ≥1 episode of acute diabetic complications (e.g., diabetic ketoacidosis, hyperglycemic hyperosmolar state) within 6 months prior to screening or prior to randomization;\n* Severe chronic diabetic complications (e.g., proliferative diabetic retinopathy, severe diabetic neuropathy, diabetic foot) within 6 months prior to screening;\n* History of acute or chronic pancreatitis at screening or prior to randomization;\n* Inflammatory bowel disease, partial intestinal obstruction, or chronic intestinal diseases associated with malabsorption within 6 months prior to screening or prior to randomization;\n* Previous gastrointestinal surgeries that may cause malabsorption (excluding polypectomy and appendectomy), or chronic use of medications directly affecting gastrointestinal motility at screening or prior to randomization;\n* Any cardiovascular event within 6 months prior to screening or prior to randomization, including: decompensated heart failure (NYHA Class III or IV); unstable angina, myocardial infarction, coronary artery bypass grafting, or coronary stent implantation; long QT syndrome or prolonged QTcF interval (male \\>450 ms, female \\>470 ms); clinically significant arrhythmia requiring treatment and deemed unsuitable for trial participation by the investigator;\n* Hemorrhagic stroke or acute ischemic stroke within 6 months prior to screening or prior to randomization;\n* Acute gallbladder disease within 6 months prior to screening, or active gallbladder disease requiring treatment at screening/prior to randomization;\n* History of severe psychiatric disorders (e.g., depression, anxiety disorders), severe osteoporosis, or other medical conditions that may endanger participant safety as judged by the investigator;\n* Malignancy (except clinically cured basal cell carcinoma or carcinoma in situ) diagnosed or treated within 5 years prior to screening or prior to randomization;\n* Severe infection or trauma within 4 weeks prior to screening/prior to randomization; recurrent urinary tract infections or genital infections within 6 months prior to screening; or symptomatic urinary/genital infections at screening/prior to randomization;\n* Clinically significant hematologic diseases (e.g., aplastic anemia, myelodysplastic syndrome) or conditions causing hemolysis or erythrocyte instability (e.g., malaria) at screening/prior to randomization;\n* Pregnant or lactating women;\n* Other conditions deemed unsuitable for trial participation by the investigator.'}, 'identificationModule': {'nctId': 'NCT07026968', 'briefTitle': 'A Study of Prusogliptin Tablets Combined With Dapagliflozin Tablets and Metformin Hydrochloride Extended Release Tablets in Type 2 Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'CSPC Ouyi Pharmaceutical Co., Ltd.'}, 'officialTitle': 'A Multicenter, Randomized, Double-blind, Parallel-controlled, Phase III Clinical Trial to Evaluate the Efficacy and Safety of the Triple Combination Therapy of Prusogliptin , Dapagliflozin and Metformin in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Alone', 'orgStudyIdInfo': {'id': 'HA1118-015'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Prusogliptin, Dapagliflozin(high dose), plus metformin XR', 'interventionNames': ['Drug: Prusogliptin, Dapagliflozin(high dose), Dapagliflozin (low dose) placebo, plus metformin XR']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Dapagliflozin(high dose), plus metformin XR', 'interventionNames': ['Drug: Prusogliptin placebo, Dapagliflozin(high dose), Dapagliflozin (low dose) placebo, plus metformin XR']}, {'type': 'EXPERIMENTAL', 'label': 'Prusogliptin, Dapagliflozin(low dose), plus metformin XR', 'interventionNames': ['Drug: Prusogliptin, Dapagliflozin(high dose) placebo, Dapagliflozin (low dose), plus metformin XR']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Dapagliflozin(low dose), plus metformin XR', 'interventionNames': ['Drug: Prusogliptin placebo, Dapagliflozin (high dose) placebo, Dapagliflozin (low dose), plus metformin XR']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Prusogliptin, plus metformin XR', 'interventionNames': ['Drug: Prusogliptin, Dapagliflozin (high dose) placebo, Dapagliflozin(low dose) placebo, plus metformin XR']}], 'interventions': [{'name': 'Prusogliptin, Dapagliflozin(high dose), Dapagliflozin (low dose) placebo, plus metformin XR', 'type': 'DRUG', 'description': 'Prusogliptin, Dapagliflozin(high dose) and Dapagliflozin (low dose) placebo, once a day, 1 tablet per dose; Metformin XR, Once a day, the dosage remains the same as the pre-screening dose.', 'armGroupLabels': ['Prusogliptin, Dapagliflozin(high dose), plus metformin XR']}, {'name': 'Prusogliptin placebo, Dapagliflozin(high dose), Dapagliflozin (low dose) placebo, plus metformin XR', 'type': 'DRUG', 'description': 'Prusogliptin placebo, Dapagliflozin (high dose), Dapagliflozin (low dose) placebo, once a day, 1 tablet per dose; Metformin XR, Once a day, the dosage remains the same as the pre-screening dose', 'armGroupLabels': ['Dapagliflozin(high dose), plus metformin XR']}, {'name': 'Prusogliptin, Dapagliflozin(high dose) placebo, Dapagliflozin (low dose), plus metformin XR', 'type': 'DRUG', 'description': 'Prusogliptin, Dapagliflozin (high dose) placebo, Dapagliflozin (low dose), once a day, 1 tablet per dose; Metformin XR, Once a day, the dosage remains the same as the pre-screening dose', 'armGroupLabels': ['Prusogliptin, Dapagliflozin(low dose), plus metformin XR']}, {'name': 'Prusogliptin placebo, Dapagliflozin (high dose) placebo, Dapagliflozin (low dose), plus metformin XR', 'type': 'DRUG', 'description': 'Prusogliptin placebo, Dapagliflozin (high dose) placebo, Dapagliflozin (low dose), once a day, 1 tablet per dose; Metformin XR, Once a day, the dosage remains the same as the pre-screening dose', 'armGroupLabels': ['Dapagliflozin(low dose), plus metformin XR']}, {'name': 'Prusogliptin, Dapagliflozin (high dose) placebo, Dapagliflozin(low dose) placebo, plus metformin XR', 'type': 'DRUG', 'description': 'Prusogliptin, Dapagliflozin (high dose) placebo, Dapagliflozin (low dose) placebo, once a day, 1 tablet per dose; Metformin XR, Once a day, the dosage remains the same as the pre-screening dose', 'armGroupLabels': ['Prusogliptin, plus metformin XR']}]}, 'contactsLocationsModule': {'locations': [{'zip': '050035', 'city': 'Shijiazhuang', 'state': 'Hebei', 'country': 'China', 'facility': 'No. 896, Zhongshan East Road, High-tech Industrial Development Zone', 'geoPoint': {'lat': 38.04139, 'lon': 114.47861}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CSPC Ouyi Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}