Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
Location status: Recruiting
NCT Number: NCT06838286
A multicenter, prospective, non-interventional observation study to evaluate the safety and effectiveness of OAD triple therapy in Korean Type 2 diabetic mellitus patients.
Interested in participating?
Request Info19 year and older
All sexes
Observational
Seongnam-si, Gyeonggi-do, South Korea
Location status: Recruiting
The study was designed as a multicenter, prospective, non-interventional, observational study in patients with type 2 diabetes mellitus who had inadequate glycemic control with conventional combination oral hypoglycemic agents including metformin.
Participants in this study will have type 2 diabetes mellitus with insufficient glycemic control on conventional combination therapy with a DPP-4i or SGLT2i oral hypoglycemic agent, including metformin, requiring the addition of one of the following: SGLT-2i, DPP-4i, or TZD.
The 3-drug combination therapy will be prescribed to subjects based on the medical judgment of the investigator based on the licensure of SGLT-2i, DPP-4i, or TZD(efficacy, dosing, precautions for use, etc.) in a real-world practice setting and all treatment and observation, including administration of medications and laboratory tests, will be based on the medical judgment of the investigator.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
SGLT2 inhibitor class of drugs
Thiazolidinedione class of drugs
DPP4 inhibitor class of drugs
Time frame: 24 month
Safety assessment of triple combination therapy with Metformin SGLT2i or DPP4i and TZD class drugs(All adverse events occurring after the date of registration).
Time frame: 3, 6, (9), 12, 18, and 24 months
Evaluation of HbA1c(%) Change Compared to Baseline in Each Combination Group
Time frame: 3, 6, (9), 12, 18, and 24 months
Evaluation of FPG(mg/dL) Change Compared to Baseline in Each Combination Group
Time frame: 3, 6, (9), 12, 18, and 24 months
Percentage of Subjects with HbA1c < 7.0% in Each Combination Group
Time frame: 3, 6, (9), 12, 18, and 24 months
Percentage of Subjects with HbA1c < 6.5% in Each Combination Group
Time frame: 24 month
demographics, past hypoglycemic medications, hypoglycemic medication components and doses, duration of hypoglycemic medication, duration of disease, comorbidities, concomitant medications, etc.
Time frame: 3, 6, (9), 12, 18, 24 months
Changes in Weight(kg) Compared to Baseline in Each Combination Group
Time frame: 12 and 24 months
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))
Time frame: 6, 12, 18, and 24 months
Changes in Fatty Liver Index compared to Baseline in Each Combination Group
Time frame: 6, 12, 18, and 24 months
Changes in AST(IU/L) Compared to Baseline in Each Combination Group
Time frame: 6, 12, 18, and 24 months
Changes in ALT(IU/L) Compared to Baseline in Each Combination Group
Time frame: 6, 12, 18, and 24 months
Changes in Platelet(10^3/uL) Levels Compared to Baseline in Each Combination Group
Time frame: 6, 12, 18, and 24 months
Change in Total cholesterol, LDL-C, HDL-C, TG(mg/dL) compared to Baseline in Each Combination Group
Time frame: 12 and 24 months
Changes in HOMA-IR(%), HOMA-(%) compared to Baseline in Each Combination Group
Time frame: 12 and 24 months
Changes in eGFR(mL/min/1.73m2) compared to Baseline in Each Combination Group
Time frame: 12 and 24 months
Changes in UACR(mg/g) compared to Baseline in Each Combination Group
Time frame: 12 and 24 months
Change in hsCRP(mg/dL) compared to Baseline in Each Combination Group
Time frame: 12 and 24 months
Change in ProBNP(or NT-ProBNP)(pg/mL) compared to Baseline in Each Combination Group
Time frame: 3, 6, (9), 12, 18, and 24 months
Change in PP2(mg/dL) compared to Baseline in Each Combination Group.
Time frame: 24 month
Incidence Rate of Major Adverse Cardiovascular Events(MACE) from Baseline to 24 Months for Each Combination Group
Time frame: 24 month
Incidence Rate of Diabetic Microvascular Events from Baseline to 24 Months for Each Combination Group
Contact information is provided by the study sponsor or research team.
Chong Kun Dang Pharmaceutical
Industry
A Multicenter, Prospective, Non-interventional Observation Study to Evaluate the Safety and Effectiveness of OAD Triple Therapy in Korean Type 2 Diabetic Mellitus Patients
Acronym: TRIO
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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