Nctid:
NCT06222476
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000003928", "term"=>"Diabetic Nephropathies"}], "ancestors"=>[{"id"=>"D000007674", "term"=>"Kidney Diseases"}, {"id"=>"D000014570", "term"=>"Urologic Diseases"}, {"id"=>"D000052776", "term"=>"Female Urogenital Diseases"}, {"id"=>"D000005261", "term"=>"Female Urogenital Diseases and Pregnancy Complications"}, {"id"=>"D000091642", "term"=>"Urogenital Diseases"}, {"id"=>"D000052801", "term"=>"Male Urogenital Diseases"}, {"id"=>"D000048909", "term"=>"Diabetes Complications"}, {"id"=>"D000003920", "term"=>"Diabetes Mellitus"}, {"id"=>"D000004700", "term"=>"Endocrine System Diseases"}], "browseLeaves"=>[{"id"=>"M7119", "name"=>"Diabetes Mellitus, Type 2", "relevance"=>"LOW"}, {"id"=>"M7115", "name"=>"Diabetes Mellitus", "relevance"=>"LOW"}, {"id"=>"M10698", "name"=>"Kidney Diseases", "relevance"=>"LOW"}, {"id"=>"M7123", "name"=>"Diabetic Nephropathies", "asFound"=>"Diabetic Nephropathy", "relevance"=>"HIGH"}, {"id"=>"M17319", "name"=>"Urologic Diseases", "relevance"=>"LOW"}, {"id"=>"M2875", "name"=>"Urogenital Diseases", "relevance"=>"LOW"}, {"id"=>"M27093", "name"=>"Female Urogenital Diseases", "relevance"=>"LOW"}, {"id"=>"M14127", "name"=>"Pregnancy Complications", "relevance"=>"LOW"}, {"id"=>"M8399", "name"=>"Female Urogenital Diseases and Pregnancy Complications", "relevance"=>"LOW"}, {"id"=>"M27095", "name"=>"Male Urogenital Diseases", "relevance"=>"LOW"}, {"id"=>"M26004", "name"=>"Diabetes Complications", "relevance"=>"LOW"}, {"id"=>"M7862", "name"=>"Endocrine System Diseases", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Nutritional and Metabolic Diseases", "abbrev"=>"BC18"}, {"name"=>"Gland and Hormone Related Diseases", "abbrev"=>"BC19"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Urinary Tract, Sexual Organs, and Pregnancy Conditions", "abbrev"=>"BXS"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D000005907", "term"=>"Gliclazide"}], "ancestors"=>[{"id"=>"D000007004", "term"=>"Hypoglycemic Agents"}, {"id"=>"D000045505", "term"=>"Physiological Effects of Drugs"}], "browseLeaves"=>[{"id"=>"M11667", "name"=>"Metformin", "relevance"=>"LOW"}, {"id"=>"M9018", "name"=>"Gliclazide", "asFound"=>"Casein", "relevance"=>"HIGH"}, {"id"=>"M10054", "name"=>"Hypoglycemic Agents", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Hypoglycemic Agents", "abbrev"=>"Hypo"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"DOUBLE", "whoMasked"=>["PARTICIPANT", "INVESTIGATOR"]}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"CROSSOVER"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>106}}, "statusModule"=>{"overallStatus"=>"NOT_YET_RECRUITING", "startDateStruct"=>{"date"=>"2024-02-20", "type"=>"ESTIMATED"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-01", "completionDateStruct"=>{"date"=>"2026-06-30", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-01-16", "studyFirstSubmitDate"=>"2024-01-16", "studyFirstSubmitQcDate"=>"2024-01-16", "lastUpdatePostDateStruct"=>{"date"=>"2024-01-24", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-24", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2025-05-31", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Participants' personal information", "timeFrame"=>"1 day", "description"=>"Self-reported information (age in years, gender，course of disease )"}, {"measure"=>"Physical assessments", "timeFrame"=>"1 day", "description"=>"BMI (body mass index) in kg/m\\^2"}, {"measure"=>"renal function", "timeFrame"=>"1 day", "description"=>"changes of renal function (eGFR, creatinine, cystatin C, TNF-1)"}, {"measure"=>"renal magnetic resonance imaging(MRI)", "timeFrame"=>"1 day", "description"=>"Changes of perirenal fat content, renal proton density fat fraction and degree of renal fibrosis"}], "secondaryOutcomes"=>[{"measure"=>"blood sugar", "timeFrame"=>"1 day", "description"=>"fasting blood sugar、2-hour postprandial blood sugar"}, {"measure"=>"insulin", "timeFrame"=>"1 day", "description"=>"fasting insulin、2-hour insulin"}, {"measure"=>"HOMA2-β", "timeFrame"=>"1 day", "description"=>"20\\*fasting insulin（mIU/L）/（fasting blood sugar（mmol/L）-3.5）"}, {"measure"=>"HOMA2-IR", "timeFrame"=>"1 day", "description"=>"fasting blood sugar（mmol/L）\\*fasting insulin（mIU/L）/22.5"}, {"measure"=>"HOMA2-IS", "timeFrame"=>"1 day", "description"=>"22.5/fasting blood sugar（mmol/L）\\*fasting insulin（mIU/L）"}]}, "oversightModule"=>{"oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Diabetic Nephropathy Type 2"]}, "referencesModule"=>{"references"=>[{"pmid"=>"35551292", "type"=>"BACKGROUND", "citation"=>"Yang W, Zhu D, Gan S, Dong X, Su J, Li W, Jiang H, Zhao W, Yao M, Song W, Lu Y, Zhang X, Li H, Wang G, Qiu W, Yuan G, Ma J, Li W, Li Z, Wang X, Zeng J, Yang Z, Liu J, Liang Y, Lu S, Zhang H, Liu H, Liu P, Fan K, Jiang X, Li Y, Su Q, Ning T, Tan H, An Z, Jiang Z, Liu L, Zhou Z, Zhang Q, Li X, Shan Z, Xue Y, Mao H, Shi L, Ye S, Zhang X, Sun J, Li P, Yang T, Li F, Lin J, Zhang Z, Zhao Y, Li R, Guo X, Yao Q, Lu W, Qu S, Li H, Tan L, Wang W, Yao Y, Chen D, Li Y, Gao J, Hu W, Fei X, Wu T, Dong S, Jin W, Li C, Zhao D, Feng B, Zhao Y, Zhang Y, Li X, Chen L. Dorzagliatin add-on therapy to metformin in patients with type 2 diabetes: a randomized, double-blind, placebo-controlled phase 3 trial. Nat Med. 2022 May;28(5):974-981. doi: 10.1038/s41591-022-01803-5. Epub 2022 May 12."}, {"pmid"=>"30352097", "type"=>"BACKGROUND", "citation"=>"Simons PIHG, Simons N, Stehouwer CDA, Schalkwijk CG, Schaper NC, Brouwers MCGJ. Association of common gene variants in glucokinase regulatory protein with cardiorenal disease: A systematic review and meta-analysis. PLoS One. 2018 Oct 23;13(10):e0206174. doi: 10.1371/journal.pone.0206174. eCollection 2018."}, {"pmid"=>"24535998", "type"=>"BACKGROUND", "citation"=>"Hishida A, Takashima N, Turin TC, Kawai S, Wakai K, Hamajima N, Hosono S, Nishida Y, Suzuki S, Nakahata N, Mikami H, Ohnaka K, Matsui D, Katsuura-Kamano S, Kubo M, Tanaka H, Kita Y. GCK, GCKR polymorphisms and risk of chronic kidney disease in Japanese individuals: data from the J-MICC Study. J Nephrol. 2014 Apr;27(2):143-9. doi: 10.1007/s40620-013-0025-0. Epub 2013 Dec 17."}, {"pmid"=>"36243233", "type"=>"BACKGROUND", "citation"=>"Wang K, Shi M, Yang A, Fan B, Tam CHT, Lau E, Luk AOY, Kong APS, Ma RCW, Chan JCN, Chow E. GCKR and GCK polymorphisms are associated with increased risk of end-stage kidney disease in Chinese patients with type 2 diabetes: The Hong Kong Diabetes Register (1995-2019). Diabetes Res Clin Pract. 2022 Nov;193:110118. doi: 10.1016/j.diabres.2022.110118. Epub 2022 Oct 13."}, {"pmid"=>"34217586", "type"=>"BACKGROUND", "citation"=>"Lin L, Dekkers IA, Huang L, Tao Q, Paiman EHM, Bizino MB, Jazet IM, Lamb HJ. Renal sinus fat volume in type 2 diabetes mellitus is associated with glycated hemoglobin and metabolic risk factors. J Diabetes Complications. 2021 Sep;35(9):107973. doi: 10.1016/j.jdiacomp.2021.107973. Epub 2021 Jun 15."}]}, "descriptionModule"=>{"briefSummary"=>"The main purpose of this study is to explore the improvement of renal function before and after the intervention of dorzagliatin in patients with type 2 diabetes.", "detailedDescription"=>"As soon，metformin、SGLT-2i、GLP-1RA have been confirmed to have protective effect on the kidneys in the statement of consensus at home and abroad. Dorzagliatin exerts a potent hypoglycemic effect by activating glucokinase and is not affected by the patient's renal function. However, previous studies of this drug have rarely involved studies that improve markers related to renal function. On the one hand, in this study, changes of renal function (eGFR, creatinine, cystatin C, TNF-1) are collected to investigate whether dorzagliatin is benefit to kidney. On the other hand, renal magnetic resonance imaging(MRI) results are analysed to explore the differences among control subjects and patients treated with dorzagliatin."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "maximumAge"=>"75 years", "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n1. Age:18-75 years old, male and female.\n2. Patients with type 2 diabetes mellitus, type 2 diabetes mellitus diagnosis criteria: according to the \"Chinese Type 2 Diabetes Mellitus Prevention and Treatment Guide (2020 Edition).\n3. UACR 30-299mg/g.\n4. eGFR ≥60mL/min/1.73m².\n5. HbA1c 7.0-10.5%.\n\nExclusion Criteria:\n\n1. Pregnant and lactating women and women of childbearing age who do not want to take reliable contraceptive measures.\n2. Known allergic history to dorzagliatin/gliclazide/metformin.\n3. Diabetic acute and chronic complications, including diabetic ketoacidosis, a hyperglycemic hyperosmolar state or hypoglycemic coma, etc.\n4. Serious impairment of heart, liver, kidney and other organs.\n5. With hypertension(≥140/90mmHg).\n6. Fasting C-peptide \\<300pmol/L.\n7. Contraindications of MRI examination, such as implantation of metal prosthesis in vivo, claustrophobia, wearing insulin pumps, etc."}, "identificationModule"=>{"nctId"=>"NCT06222476", "briefTitle"=>"Effect of Dorzagliatin on Renal Function Outcomes in People With Type 2 Diabetes: a Multicentric, Prospective, Randomized Study.", "organization"=>{"class"=>"OTHER", "fullName"=>"The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School"}, "officialTitle"=>"A Multicentric, Prospective, Randomized Study Evaluating the Improvement of Renal Function Outcomes With Dorzagliatin in Patients With Type 2 Diabetes Mellitus With Early Kidney Injury.", "orgStudyIdInfo"=>{"id"=>"BY2023"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"Patients treat with Dorzagliatin", "description"=>"Dorzagliatin will be initiated and maintained at 75mg twice a day until the completion of the study. Meanwhile, all patients will also continue on regimen of metformin 500mg three times a day throughout the study. Visits at 4-week intervals will be performed to evaluate the safety of drugs.", "interventionNames"=>["Drug: Dorzagliatin"]}, {"type"=>"ACTIVE_COMPARATOR", "label"=>"Patients treat with Gliclazide", "description"=>"Gliclazide will be initiated and maintained at 30mg once a day until the completion of the study. Meanwhile, all patients will also continue on regimen of metformin 500mg three times a day throughout the study. Visits at 4-week intervals will be performed to evaluate the safety of drugs.", "interventionNames"=>["Drug: Gliclazide"]}], "interventions"=>[{"name"=>"Dorzagliatin", "type"=>"DRUG", "description"=>"Dorzagliatin will be initiated and maintained at 75mg twice a day", "armGroupLabels"=>["Patients treat with Dorzagliatin"]}, {"name"=>"Gliclazide", "type"=>"DRUG", "description"=>"Gliclazide will be initiated and maintained at 30mg once a day", "armGroupLabels"=>["Patients treat with Gliclazide"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"210008", "city"=>"Nanjing", "state"=>"Jiangsu", "country"=>"China", "facility"=>"Division of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University", "geoPoint"=>{"lat"=>32.06167, "lon"=>118.77778}}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"UNDECIDED"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Yan Bi", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"SPONSOR_INVESTIGATOR", "investigatorTitle"=>"Chief Physician", "investigatorFullName"=>"Yan Bi", "investigatorAffiliation"=>"The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School"}}}}
