Korean Study on Safety and Effectiveness of OAD Triple Therapy in Type 2 Diabetes

Recruiting

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: SGLT2 inhibitor; Drug: Thiazolidinedione; Drug: DPP-4 inhibitor

• Registration Number: NCT06838286
• Lead Sponsor: Chong Kun Dang Pharmaceutical

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.

Study Timeline

• Study Start: 2024-03-16
• Study First Submitted: 2024-06-30
• Status Verified: 2025-02
• Study First Submitted QC: 2025-02-18
• Last Update Submitted: 2025-02-18
• Study First Posted: 2025-02-20
• Last Update Posted: 2025-02-20
• Primary Completion: 2026-12-31
• Study Completion: 2029-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Metformin/DPP4i/SGLT2i	SGLT2 inhibitor	Metformin + DPP4i 2-drug combination plus one of the SGLT-2i class of drugs.
Metformin/DPP4i/SGLT2i	DPP-4 inhibitor	Metformin + DPP4i 2-drug combination plus one of the SGLT-2i class of drugs.
Metformin/DPP4i/TZD	Thiazolidinedione	Metformin + DPP4i 2-drug combination plus one of the TZD class of drugs.
Metformin/DPP4i/TZD	DPP-4 inhibitor	Metformin + DPP4i 2-drug combination plus one of the TZD class of drugs.
Metformin/SGLT2i/DPP4i	SGLT2 inhibitor	Metformin + SGLT2i 2-drug combination plus one of the DPP4i class of drugs.
Metformin/SGLT2i/DPP4i	DPP-4 inhibitor	Metformin + SGLT2i 2-drug combination plus one of the DPP4i class of drugs.
Metformin/SGLT2i/TZD	SGLT2 inhibitor	Metformin + SGLT2i 2-drug combination plus one of the TZD class of drugs.
Metformin/SGLT2i/TZD	Thiazolidinedione	Metformin + SGLT2i 2-drug combination plus one of the TZD class of drugs.

Primary Outcome Measures

Name	Time	Method
Evaluation of Incidence of Adverse events in Triple Combination Therapy Including Metformin with SGLT-2i, DPP-4i, or TZD Class Drugs.	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).

Secondary Outcome Measures

Name	Time	Method
Changes in HbA1c	3, 6, (9), 12, 18, and 24 months	Evaluation of HbA1c(%) Change Compared to Baseline in Each Combination Group
Changes in FPG	3, 6, (9), 12, 18, and 24 months	Evaluation of FPG(mg/dL) Change Compared to Baseline in Each Combination Group
Percentage of Subjects with HbA1c < 7.0%	3, 6, (9), 12, 18, and 24 months	Percentage of Subjects with HbA1c \< 7.0% in Each Combination Group
Percentage of Subjects with HbA1c < 6.5%	3, 6, (9), 12, 18, and 24 months	Percentage of Subjects with HbA1c \< 6.5% in Each Combination Group
Factors influencing HbA1c change at each endpoint for each combination group.	24 month	demographics, past hypoglycemic medications, hypoglycemic medication components and doses, duration of hypoglycemic medication, duration of disease, comorbidities, concomitant medications, etc.

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam-si, Gyeonggi-do, Korea, Republic of