Clinical trial NCT06838286: Korean Study on Safety and Effectiveness of OAD Triple Therapy in Type 2 Diabetes
Official title: A Multicenter, Prospective, Non-interventional Observation Study to Evaluate the Safety and Effectiveness of OAD Triple Therapy in Korean Type 2 Diabetic Mellitus Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Diabetes Mellitus, Type 2
Keywords: Type 2 diabetes mellitus
Korean patients
Observational study
OAD triple therapy
Lead sponsor: Chong Kun Dang Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2025-02-20
Enrollment: 10000
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with type 2 diabetes mellitus whose glycemic control is inadequate on 2 oral hypoglycemic agents, including metformin.

Brief summary: A multicenter, prospective, non-interventional observation study to evaluate the safety and effectiveness of OAD triple therapy in Korean Type 2 diabetic mellitus patients.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Patients with type 2 diabetes who are 19 years of age or older at the time of enrollment.
2. Continued DPP-4i or SGLT-2i oral hypoglycemic combination therapy with metformin for at least 8 weeks prior to enrollment.
3. 7.0% ≤ HbA1c \< 10.0% based on laboratory tests performed within 4 weeks of enrollment.
4. Voluntarily give written informed consent after being told about the study.

Exclusion Criteria:

1. Patients with type 1 diabetes and secondary diabetes.
2. Patients receiving concomitant therapy with 3 or more oral hypoglycemic agents within 8 weeks of enrollment.
3. Requiring treatment with insulin, GLP-1, etc. in addition to oral hypoglycemic agents during the study.
4. End-stage renal disease and hemodialysis patients.
5. diabetic ketoacidosis Patients.
6. Pregnant and lactating women.
7. Patients who are contraindicated by any of the "Precautions for Use" in the license for the drug being administered during the study, given the observational nature of the study under routine practice.
8. Patients with a history of hypersensitivity to the investigational drug or any of its components or excipients.
9. Anyone else deemed by the investigator to be unsuitable for participation in the study.

Primary outcomes:
measure: Evaluation of Incidence of Adverse events in Triple Combination Therapy Including Metformin with SGLT-2i, DPP-4i, or TZD Class Drugs.
timeFrame: 24 month
Secondary outcomes:
measure: Changes in HbA1c
timeFrame: 3, 6, (9), 12, 18, and 24 months
measure: Changes in FPG
timeFrame: 3, 6, (9), 12, 18, and 24 months
measure: Percentage of Subjects with HbA1c < 7.0%
timeFrame: 3, 6, (9), 12, 18, and 24 months
measure: Percentage of Subjects with HbA1c < 6.5%
timeFrame: 3, 6, (9), 12, 18, and 24 months
measure: Factors influencing HbA1c change at each endpoint for each combination group.
timeFrame: 24 month
Other outcomes:
measure: Changes in Weight
timeFrame: 3, 6, (9), 12, 18, 24 months
measure: Changes in waist circumference
timeFrame: 12 and 24 months
measure: Changes in Fatty Liver Index
timeFrame: 6, 12, 18, and 24 months
measure: Changes in AST
timeFrame: 6, 12, 18, and 24 months
measure: Changes in ALT
timeFrame: 6, 12, 18, and 24 months
measure: Changes Platelet Levels
timeFrame: 6, 12, 18, and 24 months
measure: Changes in Blood Lipid Levels(Total cholesterol, LDL-C, HDL-C, TG)
timeFrame: 6, 12, 18, and 24 months
measure: Changes in Insulin-Related Test Levels(HOMA-IR, HOMA-β)
timeFrame: 12 and 24 months
measure: Changes in eGFR
timeFrame: 12 and 24 months
measure: Changes in UACR
timeFrame: 12 and 24 months
measure: Change in hsCRP
timeFrame: 12 and 24 months
measure: Change in ProBNP(or NT-ProBNP)
timeFrame: 12 and 24 months
measure: Change in PP2 Compared to Baseline in Each Combination Group
timeFrame: 3, 6, (9), 12, 18, and 24 months
measure: Incidence Rate of Major Adverse Cardiovascular Events(MACE)
timeFrame: 24 month
measure: Incidence Rate of Diabetic Microvascular Events
timeFrame: 24 month
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
Study officials:
References: