Ignite Creation Date:
2025-12-25 @ 1:15 AM
Ignite Modification Date:
2026-01-01 @ 5:38 AM
Study NCT ID:
NCT06875193
Status:
RECRUITING
Last Update Posted:
2025-03-17
First Post:
2025-02-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
DM Treatment to Evaluate the Efficacy and Safety of Dapagliflozin or Pioglitazone in Patients with Type 2 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 196}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-05-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-12', 'studyFirstSubmitDate': '2025-02-24', 'studyFirstSubmitQcDate': '2025-03-10', 'lastUpdatePostDateStruct': {'date': '2025-03-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Variance in HbA1c from baseline to 24 weeks on study drug', 'timeFrame': '24 weeks', 'description': 'Change in HbA1c'}], 'secondaryOutcomes': [{'measure': 'Variance in HbA1c from baseline to 12 weeks on study drug', 'timeFrame': '12 weeks', 'description': 'Change in HbA1c'}, {'measure': 'Variance in FPG from baseline to 12, 24 weeks on study drug', 'timeFrame': '12, 24 weeks', 'description': 'Change in Fasting Plasma Glucose(FPG)'}, {'measure': 'Variance in TC(mg/dL), TG(mg/dL), HDL(mg/dL), LDL(mg/dL) from baseline to 12, 24 weeks on study drug', 'timeFrame': '12, 24 weeks', 'description': 'Change in TC, TG, HDL, LDL'}, {'measure': 'Variance in FLI(Fatty Liver Index), AST, ALT, r-GTP, ALP, HSI(Hepatic steatosis index), Total bilirubin, Albumin, Protein from baseline to 12 and 24 weeks after study drug administration', 'timeFrame': '12, 24 weeks', 'description': 'FLI(Fatty Liver Index)= 1/(1+exp(-x))×100\n\nHSI(Hepatic steatosis index) = 8×ALT/AST+BMI(+2, if type 2 diabetes yes, +2 if female)'}, {'measure': 'Variance in Kidney value from baseline to 12, 24 weeks on study drug', 'timeFrame': '12, 24 weeks', 'description': 'Kidney value: eGFR(CKD-EPI fomulation) ACR(Albumin to Creatine ratio), Creatinine'}, {'measure': 'Variance in body weight from baseline to 12, 24 weeks on study drug', 'timeFrame': '12, 24 weeks'}, {'measure': 'Percentage of patients achieving HbA1c of 7.0% or 6.5% or less at 12 and 24 weeks post study drug administration compared to baseline', 'timeFrame': '12, 24 weeks', 'description': 'Percentage of patients achieving HbA1c of 7.0% or 6.5% or less'}, {'measure': 'Variance in Insulin from baseline to 12, 24 weeks on study drug', 'timeFrame': '12, 24 weeks'}, {'measure': 'Percentage of subjects prescribed an rescue drug during this study', 'timeFrame': 'during 24weeks(study duration/per subject)', 'description': 'rescue drug'}, {'measure': 'Variance in waist measurement from baseline to 12, 24 weeks on study drug', 'timeFrame': '12, 24 weeks'}, {'measure': 'Variance in BMI from baseline to 12, 24 weeks on study drug', 'timeFrame': '12, 24 weeks'}, {'measure': 'Variance in blood pressure from baseline to 12, 24 weeks on study drug', 'timeFrame': '12, 24 weeks'}, {'measure': 'Variance in HOMA-IR, HOMA-β(Glucose in Molar Units mmol/L) from baseline to 12, 24 weeks on study drug', 'timeFrame': '12, 24 weeks'}, {'measure': 'Variance in c-peptide from baseline to 12, 24 weeks on study drug', 'timeFrame': '12, 24 weeks'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Dapagliflozin', 'Pioglitazone', 'DPP-4 inhibitor'], 'conditions': ['Type2diabetes']}, 'descriptionModule': {'briefSummary': 'Key finding of DM Treatment with combination, A MuLticenter, Randomized, Parallel, Gathering Information of phase 4 Trial to Evaluate the Efficacy and Safety of Dapagliflozin or Pioglitazone add-on to Metformin and DPP-4 inhibitor in Patients with Type 2 Diabetes Who Have Inadequate Glycaemic Control on a Background Combination of Metformin and DPP-4 inhibitor(KLIMT Study)', 'detailedDescription': 'This is a Phase 4, multicenter, randomized, open-label, parallel clinical trial'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with type 2 diabetes who are 19 years of age or older at the date of written consent\n* Subjects who Receiving a stable dose of metformin and a DPP-4 inhibitor for at least the last 8 weeks at the time of screening\n* HbA1c ≤ 7.0% ≤ HbA1c \\< 10% at time of screening\n* BMI ≤ 18.5 kg/m2 ≤ 40 kg/m2 at time of screening\n* Subjects fully explained and understood the purpose and methods of this study and voluntarily gave written informed consent\n\nExclusion Criteria:\n\n* Patients with type 1 diabetes\n* Have a BMI \\> 40 kg/m2\n* Subjects who have moderate (Stage 3b) or severe kidney disease or an estimated glomerular filtration rate (eGFR, using the CKD-EPI formula) \\< 45 mL/min/1.73 m2\n* Patients with end stage renal disease or patients on dialysis\n* Patients with uncontrolled heart failure (NYHA class III - IV)\n* Patients with history of uncontrolled arrhythmia, myocardial infarction, unstable angina, coronary artery bypass graft surgery, cerebrovascular disease within 24 weeks prior to the screening visit\n* Patients with acute or chronic metabolic acidosis, including lactic acidosis, diabetic ketoacidosis (DKA) with or without coma, and patients with a history of ketoacidosis\n* Patients with diabetic coma or precoma\n* Patients with a history of severe hypoglycemia while taking metformin and DPP-4 inhibitors.\n* Patients with hematuria\n* Patients who receiving treatment for thyroid dysfunction at the time of screening\n* Malnourished, starving, or debilitated subjects\n* Patients with pituitary insufficiency or adrenal insufficiency\n* Patients with clinically significant hepatic disease with AST or ALT greater than 3 times the upper limit of normal\n* Patients with severe infectious diseases, perioperative, or clinically significant trauma\n* Have a history of substance abuse\n* Patients receiving insulin or sulfonylurea, thiazolidinedione, SGLT2 inhibitor, GLP-1 receptor agonist within 8 weeks prior to the screening visit\n* Patients who have received more than 2 consecutive weeks of corticosteroids within 8 weeks at the time of screening or who require treatment requiring repeated use of corticosteroids\n* Patients with a history of malignancy within the last 5 years\n* Participation in any other clinical trial within 12 weeks of screening in which an investigational drug or investigational medical device was administered or applied\n* Pregnant and breastfeeding women\n* Hypersensitivity to any of the drugs and components, including metformin, DPP-4 inhibitors, dapagliflozin, TZDs, sulfonylurea class of drugs, or any of the ingredients\n* Patients with genetic problems such as galactose intolerance, Lapp lactose deficiency, or glucose-galactose mal-absorption.\n* Any other person deemed by the investigator to be unsuitable for participation in the study'}, 'identificationModule': {'nctId': 'NCT06875193', 'acronym': 'KLIMT', 'briefTitle': 'DM Treatment to Evaluate the Efficacy and Safety of Dapagliflozin or Pioglitazone in Patients with Type 2 Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Dong Wha Pharmaceutical Co. Ltd.'}, 'officialTitle': 'Key Finding of DM Treatment with Combination, a MuLticenter, Randomized, Parallel, Gathering Information of Phase 4 Trial to Evaluate the Efficacy and Safety of Dapagliflozin or Pioglitazone Add-on to Metformin and DPP-4 Inhibitor in Patients with Type 2 Diabetes', 'orgStudyIdInfo': {'id': 'DW6012-IV-2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dasidiem 10/100mg', 'description': 'Dapagliflozin 10mg +sitagliptin 100mg combination drug', 'interventionNames': ['Drug: DW6012(Dasidiem tab. 10/100mg)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'sitdiem 100mg, Piotazone15mg', 'description': 'sitagliptin 100mg, Pioglitazone 15mg', 'interventionNames': ['Drug: DW6012(Dasidiem tab. 10/100mg)']}], 'interventions': [{'name': 'DW6012(Dasidiem tab. 10/100mg)', 'type': 'DRUG', 'otherNames': ['Piotazone tab.', 'Sitdiem tab. 100mg'], 'description': 'Once a day, Oral administration', 'armGroupLabels': ['Dasidiem 10/100mg', 'sitdiem 100mg, Piotazone15mg']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Kyung Hee University Hospital at Gangdong', 'role': 'CONTACT', 'email': 'cri@khnmc.or.kr', 'phone': '82+2-440-7000'}], 'facility': 'Kyung Hee University Hospital at Gangdong', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dong Wha Pharmaceutical Co. Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}