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Clinical Trial Details

Trial ID: L3009
Source ID: NCT06838286
Associated Drug: Sglt2 Inhibitor
Title: Korean Study on Safety and Effectiveness of OAD Triple Therapy in Type 2 Diabetes
Acronym: TRIO
Status: RECRUITING
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: SGLT2 inhibitor|DRUG: Thiazolidinedione|DRUG: DPP-4 inhibitor
Outcome Measures: Primary: Evaluation of Incidence of Adverse events in Triple Combination Therapy Including Metformin with SGLT-2i, DPP-4i, or TZD Class Drugs., Safety assessment of triple combination therapy with Metformin SGLT2i or DPP4i and TZD class drugs(All adverse events occurring after the date of registration)., 24 month | Secondary: Changes in HbA1c, Evaluation of HbA1c(%) Change Compared to Baseline in Each Combination Group, 3, 6, (9), 12, 18, and 24 months|Changes in FPG, Evaluation of FPG(mg/dL) Change Compared to Baseline in Each Combination Group, 3, 6, (9), 12, 18, and 24 months|Percentage of Subjects with HbA1c < 7.0%, Percentage of Subjects with HbA1c \< 7.0% in Each Combination Group, 3, 6, (9), 12, 18, and 24 months|Percentage of Subjects with HbA1c < 6.5%, Percentage of Subjects with HbA1c \< 6.5% in Each Combination Group, 3, 6, (9), 12, 18, and 24 months|Factors influencing HbA1c change at each endpoint for each combination group., demographics, past hypoglycemic medications, hypoglycemic medication components and doses, duration of hypoglycemic medication, duration of disease, comorbidities, concomitant medications, etc., 24 month | Other: Changes in Weight, Changes in Weight(kg) Compared to Baseline in Each Combination Group, 3, 6, (9), 12, 18, 24 months|Changes in waist circumference, Changes in waist circumference(cm) compared to Baseline in Each Combination Group (body composition in body water(L), protein(kg), minerals(kg), and body fat(kg)), 12 and 24 months|Changes in Fatty Liver Index, Changes in Fatty Liver Index compared to Baseline in Each Combination Group, 6, 12, 18, and 24 months|Changes in AST, Changes in AST(IU/L) Compared to Baseline in Each Combination Group, 6, 12, 18, and 24 months|Changes in ALT, Changes in ALT(IU/L) Compared to Baseline in Each Combination Group, 6, 12, 18, and 24 months|Changes Platelet Levels, Changes in Platelet(10\^3/uL) Levels Compared to Baseline in Each Combination Group, 6, 12, 18, and 24 months|Changes in Blood Lipid Levels(Total cholesterol, LDL-C, HDL-C, TG), Change in Total cholesterol, LDL-C, HDL-C, TG(mg/dL) compared to Baseline in Each Combination Group, 6, 12, 18, and 24 months|Changes in Insulin-Related Test Levels(HOMA-IR, HOMA-β), Changes in HOMA-IR(%), HOMA-(%) compared to Baseline in Each Combination Group, 12 and 24 months|Changes in eGFR, Changes in eGFR(mL/min/1.73m2) compared to Baseline in Each Combination Group, 12 and 24 months|Changes in UACR, Changes in UACR(mg/g) compared to Baseline in Each Combination Group, 12 and 24 months|Change in hsCRP, Change in hsCRP(mg/dL) compared to Baseline in Each Combination Group, 12 and 24 months|Change in ProBNP(or NT-ProBNP), Change in ProBNP(or NT-ProBNP)(pg/mL) compared to Baseline in Each Combination Group, 12 and 24 months|Change in PP2 Compared to Baseline in Each Combination Group, Change in PP2(mg/dL) compared to Baseline in Each Combination Group., 3, 6, (9), 12, 18, and 24 months|Incidence Rate of Major Adverse Cardiovascular Events(MACE), Incidence Rate of Major Adverse Cardiovascular Events(MACE) from Baseline to 24 Months for Each Combination Group, 24 month|Incidence Rate of Diabetic Microvascular Events, Incidence Rate of Diabetic Microvascular Events from Baseline to 24 Months for Each Combination Group, 24 month
Sponsor/Collaborators: Sponsor: Chong Kun Dang Pharmaceutical
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases:
Enrollment: 10000
Study Type: OBSERVATIONAL
Study Designs: Observational Model: |Time Perspective: p
Start Date: 2024-03-16
Completion Date: 2029-12-31
Results First Posted:
Last Update Posted: 2025-02-20
Locations: Seoul National University Bundang Hospital, Seongnam-si, Gyeonggi-do, Korea, Republic of
URL: https://clinicaltrials.gov/show/NCT06838286