Ignite Creation Date:
2025-12-25 @ 2:19 AM
Ignite Modification Date:
2025-12-28 @ 10:26 PM
Study NCT ID:
NCT04218734
Status:
COMPLETED
Last Update Posted:
2021-06-28
First Post:
2020-01-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of DBPR108 and Metformin Hydrochloride Combination Therapy in Patients With T2DM
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': 'C000718187', 'term': 'DBPR108'}, {'id': 'D008687', 'term': 'Metformin'}], 'ancestors': [{'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 214}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2021-06-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-06-23', 'studyFirstSubmitDate': '2020-01-03', 'studyFirstSubmitQcDate': '2020-01-03', 'lastUpdatePostDateStruct': {'date': '2021-06-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in HbA1c (%) from baseline to week 24', 'timeFrame': 'baseline, 24 weeks', 'description': 'The change of HbA1c from baseline to 24 weeks compared with metformin hydrochloride + placebo'}], 'secondaryOutcomes': [{'measure': 'Percentage of HbA1c ≤ 6.5%', 'timeFrame': '24 weeks', 'description': 'Proportion of patients achieving HbA1c ≤ 6.5% at week 24'}, {'measure': 'Percentage of HbA1c ≤ 7%', 'timeFrame': '24 weeks', 'description': 'Proportion of patients achieving HbA1c ≤ 7% at week 24'}, {'measure': 'Change in HbA1c (%) from baseline to week 12', 'timeFrame': 'baseline, 12 weeks', 'description': 'The change of HbA1c from baseline to 12 weeks compared with metformin hydrochloride + placebo'}, {'measure': 'Change in fasting plasma glucose (FPG) from baseline to week 12 and week 24', 'timeFrame': 'Baseline, 12 weeks and 24 weeks', 'description': 'The change in FPG from baseline to week 12 and week 24 compared with metformin hydrochloride + placebo'}, {'measure': 'Change in 2h-postprandial plasma glucose (2h-PPG) from baseline to week 12 and week 24', 'timeFrame': 'Baseline, 12 weeks and 24 weeks', 'description': 'The change in 2h-PPG from baseline to week 12 and week 24 compared with metformin hydrochloride + placebo'}, {'measure': 'Change in body weight from baseline to week 12 and week 24', 'timeFrame': 'Baseline, 12 weeks and 24 weeks', 'description': 'The change in body weight from baseline to week 12 and week 24 compared with metformin hydrochloride +placebo'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['DBPR108', 'Dipeptidyl peptidase-4 (DPP4) inhibitors', 'metformin hydrochloride'], 'conditions': ['Type 2 Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate the efficacy and safety of DBPR108 tablets in combination with metformin hydrochloride in the treatment of type 2 diabetes mellitus. A total of 210 subjects will be randomly assigned in a ratio of 2:1 to receive metformin hydrochloride plus DBPR108 or metformin hydrochloride plus placebo.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Diagnosis of type 2 diabetes according to World Health Organization (1999) diabetes diagnosis standard;\n* Age 18-75 years, men and women;\n* BMI 19-35 kg/m2;\n* HbA1c 7.0%-9.5%;\n* Before screening, a stable Metformin dose（≥1000mg/day）should be maintained for at least 8 weeks.\n* Signed informed consent from the patient;\n* Agree to use contraceptive measures from the date of signing the informed consent to 1 month after the end of the last medication.\n\nExclusion Criteria:\n\n* FPG \\> 13.9 mmol/L;\n* Insulin treatment required in the investigator's opinion;\n* Administration of antidiabetic drugs (except for metformin) including insulin, rosiglitazone, pioglitazone, DPP-4 inhibitor, Glucagon like peptide-1 (GLP-1) receptor agonist for 8 weeks before screening;\n* Acute complications of diabetes (including diabetic ketosis and ketoacidosis, hyperosmotic nonketotic diabetic coma, lactic acidosis and hypoglycemia coma);\n* Severe hypoglycemia;\n* Serious diabetic complications (such as diabetic foot, etc.);\n* History of acute or chronic pancreatitis, or related diseases that are most common cause of acute pancreatitis (such as recurrent cholelithiasis, etc.);\n* History of being allergic to DPP-4 inhibitors;\n* Untreated hyperthyroidism and other diseases which may cause secondary hyperglycemia;\n* Previous treatment with glucocorticoids (except for external use and inhalation) within 4 weeks before screening or may be used for more than 14 consecutive days during the study;\n* Inflammatory bowel disease, partial intestinal obstruction or chronic bowel disease related to obvious digestive and absorption disorders;\n* Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) \\> 3\\*upper limit of normal (ULN), or total bilirubin \\> 1.5ULN;\n* Abnormal renal function;\n* White blood cells (WBC) \\< 3.0109/l, neutrophil count of peripheral blood \\< 1.5109/l, hemoglobin \\< 100g / L, triglyceride \\> 5.7 mmol/l;\n* HBsAg, HBeAg or HBcAb positive, or any one of hepatitis C antibody, anti-HIV antibody and nonspecific antibody of Treponema pallidum positive;\n* Pregnant or lactating women;\n* History of alcohol or drug abuse;\n* Participation in other clinical trials or administration of any other investigational drugs or devices within 3 months before screening;\n* Significant unstable diseases;\n* Any condition that in the investigator's opinion might render the patient unable to participate the trial."}, 'identificationModule': {'nctId': 'NCT04218734', 'briefTitle': 'A Study of DBPR108 and Metformin Hydrochloride Combination Therapy in Patients With T2DM', 'organization': {'class': 'INDUSTRY', 'fullName': 'CSPC ZhongQi Pharmaceutical Technology Co., Ltd.'}, 'officialTitle': 'A Multicenter, Randomized, Double-blind, Parallel Controlled Phase III Clinical Trial of DBRP108 in Combination With Metformin Hydrochloride in the Treatment of Type 2 Diabetes Mellitus', 'orgStudyIdInfo': {'id': 'CSPC/DBPR108201903/PRO-III-2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'metformin hydrochloride+DBPR108', 'description': 'metformin hydrochloride 500 mg+DBPR108 100 mg', 'interventionNames': ['Drug: DBPR108', 'Drug: metformin hydrochloride']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'metformin hydrochloride+placepo', 'description': 'metformin hydrochloride 500 mg+placebo 100 mg', 'interventionNames': ['Drug: metformin hydrochloride', 'Drug: placepo']}], 'interventions': [{'name': 'DBPR108', 'type': 'DRUG', 'description': 'DBPR108: 100 mg, once daily for 24 weeks.', 'armGroupLabels': ['metformin hydrochloride+DBPR108']}, {'name': 'metformin hydrochloride', 'type': 'DRUG', 'description': 'metformin hydrochloride: 500 mg, 1-3 times daily for 24 weeks.', 'armGroupLabels': ['metformin hydrochloride+DBPR108', 'metformin hydrochloride+placepo']}, {'name': 'placepo', 'type': 'DRUG', 'description': 'placebo:100 mg, once daily for 24 weeks.', 'armGroupLabels': ['metformin hydrochloride+placepo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'country': 'China', 'facility': 'Peking Union Medical College Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Kun Lou', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of medicine, CSPC clinical development division'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CSPC ZhongQi Pharmaceutical Technology Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}