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

NCT06838286 | Recruiting DMC

• 1 other identifier: D141_01DM2303
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2

Keywords

Type 2 diabetes mellitus; Korean patients; Observational study; OAD triple therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Changes in HbA1c

  3, 6, (9), 12, 18, and 24 months

• Changes in FPG

  3, 6, (9), 12, 18, and 24 months

• Percentage of Subjects with HbA1c < 7.0%

  3, 6, (9), 12, 18, and 24 months

• Percentage of Subjects with HbA1c < 6.5%

  3, 6, (9), 12, 18, and 24 months

• Factors influencing HbA1c change at each endpoint for each combination group.

  24 month

Other Outcomes (15)

• Changes in Weight

  3, 6, (9), 12, 18, 24 months

• Changes in waist circumference

  12 and 24 months

• Changes in Fatty Liver Index

  6, 12, 18, and 24 months

Study Arms (4)

Metformin/DPP4i/SGLT2i

Metformin + DPP4i 2-drug combination plus one of the SGLT-2i class of drugs.

Drug: SGLT2 inhibitor; Drug: DPP-4 inhibitor

Metformin/DPP4i/TZD

Metformin + DPP4i 2-drug combination plus one of the TZD class of drugs.

Drug: Thiazolidinedione; Drug: DPP-4 inhibitor

Metformin/SGLT2i/DPP4i

Metformin + SGLT2i 2-drug combination plus one of the DPP4i class of drugs.

Drug: SGLT2 inhibitor; Drug: DPP-4 inhibitor

Metformin/SGLT2i/TZD

Metformin + SGLT2i 2-drug combination plus one of the TZD class of drugs.

Drug: SGLT2 inhibitor; Drug: Thiazolidinedione

Interventions

SGLT2 inhibitor DRUG

SGLT2 inhibitor class of drugs

Metformin/DPP4i/SGLT2i; Metformin/SGLT2i/DPP4i; Metformin/SGLT2i/TZD

Thiazolidinedione DRUG

Thiazolidinedione class of drugs

Metformin/DPP4i/TZD; Metformin/SGLT2i/TZD

DPP-4 inhibitor DRUG

DPP4 inhibitor class of drugs

Metformin/DPP4i/SGLT2i; Metformin/DPP4i/TZD; Metformin/SGLT2i/DPP4i

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with type 2 diabetes mellitus whose glycemic control is inadequate on 2 oral hypoglycemic agents, including metformin.

You may qualify if:

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

You may not qualify if:

• Patients with type 1 diabetes and secondary diabetes.
• Patients receiving concomitant therapy with 3 or more oral hypoglycemic agents within 8 weeks of enrollment.
• Requiring treatment with insulin, GLP-1, etc. in addition to oral hypoglycemic agents during the study.
• End-stage renal disease and hemodialysis patients.
• diabetic ketoacidosis Patients.
• Pregnant and lactating women.
• 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.
• Patients with a history of hypersensitivity to the investigational drug or any of its components or excipients.
• Anyone else deemed by the investigator to be unsuitable for participation in the study.

Sponsors & Collaborators

• Chong Kun Dang Pharmaceutical: lead

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Sodium-Glucose Transporter 2 Inhibitors; 2,4-thiazolidinedione; Dipeptidyl-Peptidase IV Inhibitors

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Hypoglycemic Agents; Physiological Effects of Drugs; Protease Inhibitors; Enzyme Inhibitors

Central Study Contacts

Soo Lim, M.D, Ph.D.

CONTACT

82-2-6373-0773; limsoo@snu.ac.kr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2024
• First Posted: February 20, 2025
• Study Start: March 16, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2029
• Last Updated: February 20, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)