Korean Study on Safety and Effectiveness of OAD Triple Therapy in Type 2 Diabetes
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SGLT2 inhibitor, Thiazolidinedione, DPP-4 inhibitor.
- Who it may be relevant to
- Registry conditions: Diabetes Mellitus, Type 2. Basic parameters: from 19 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
Interventions
- Drug SGLT2 inhibitor
SGLT2 inhibitor class of drugs - Drug Thiazolidinedione
Thiazolidinedione class of drugs - Drug DPP-4 inhibitor
DPP4 inhibitor class of drugs
Primary outcome measures
- Evaluation of Incidence of Adverse events in Triple Combination Therapy Including Metformin with SGLT-2i, DPP-4i, or TZD Class Drugs. [Time frame: 24 month]
Secondary outcome measures (5)
- Changes in HbA1c [Time frame: 3, 6, (9), 12, 18, and 24 months]
- Changes in FPG [Time frame: 3, 6, (9), 12, 18, and 24 months]
- Percentage of Subjects with HbA1c < 7.0% [Time frame: 3, 6, (9), 12, 18, and 24 months]
- Percentage of Subjects with HbA1c < 6.5% [Time frame: 3, 6, (9), 12, 18, and 24 months]
- Factors influencing HbA1c change at each endpoint for each combination group. [Time frame: 24 month]
Eligibility criteria
Inclusion criteria
- 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.
- 7.0% ≤ HbA1c < 10.0% based on laboratory tests performed within 4 weeks of enrollment.
- Voluntarily give written informed consent after being told about the study.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
South Korea · 1 center
- Seoul National University Bundang Hospital — Seongnam-si
Identifiers
NCT: NCT06838286 · D141_01DM2303