A multicenter, prospective, non-interventional observation study to evaluate the safety and effectiveness of OAD triple therapy in Korean Type 2 diabetic mellitus patients.
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 Type
OBSERVATIONAL
Enrollment
10,000
SGLT2 inhibitor class of drugs
Thiazolidinedione class of drugs
DPP4 inhibitor class of drugs
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
RECRUITINGEvaluation 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).
Time frame: 24 month
Changes in HbA1c
Evaluation of HbA1c(%) Change Compared to Baseline in Each Combination Group
Time frame: 3, 6, (9), 12, 18, and 24 months
Changes in FPG
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%
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%
Percentage of Subjects with HbA1c \< 6.5% in Each Combination Group
Time frame: 3, 6, (9), 12, 18, and 24 months
Factors influencing HbA1c change at each endpoint for each combination group.
demographics, past hypoglycemic medications, hypoglycemic medication components and doses, duration of hypoglycemic medication, duration of disease, comorbidities, concomitant medications, etc.
Time frame: 24 month
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