A Phase 4 interventional study of Empagliflozin 10 MG and Hypoglycemics Oral in Diabetes Mellitus and Fat; Intolerance, Pancreas, sponsored by Seoul National University Bundang Hospital. Status unknown at 1 site in South Korea. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2023-08-14.
Sponsored by Seoul National University Bundang Hospital · Phase 4, Interventional, and Treatment
The purpose of this study is to evaluate changes of body composition induced by Sodium-glucose cotransporter-2 (SGLT2) inhibitor and its metabolic consequence in Korean type 2 diabetes (T2D).
Sodium-glucose cotransporter-2 (SGLT2) inhibitor increases urinary excretion of glucose, promoting glycemic control and weight loss. However, it is unclear whether weight loss is attributed to decrease in fat components and associated with favorable changes in metabolic profile. The purpose of this study is to evaluate changes of body composition induced by SGLT2 inhibitor and its metabolic consequence in Korean type 2 diabetes (T2D).
11,089 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's planned enrollment of 200 is above the median of 80 across 8,491 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Seoul National University Bundang Hospital is the lead sponsor of 376 studies on the registry; 56 are open to participants now.
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Patients with type 2 diabetes Age: 20-79 years BMI ≥ 20 kg/m2 eGFR ≥ 45
Exclusion Criteria:
Patients with type 1 diabetes Secondary diabetes due to Cushing diseases, acromegaly Insulin user BMI \< 20 kg/m2 eGFR \< 45 Malignancy
up-titration of standard medication including monotherapy or combination of Metformin, Sulfonylurea, DPP4 inhibitor
Drug: Hypoglycemics Oral
addition of empagliflozin 10mg qd on standard oral antihyperglycemic agents
Drug: Empagliflozin 10 MG
addition of empagliflozin 10 MG
Also known as: SGLT2 inhibitor
dose escalation of hypoglycemics oral
Also known as: Oral antidiabetic medication escalation
HbA1c
glycemic control
Time frame: 6 months
Biochemical parameters
Ketone body concentration
Time frame: 6 months
Body weight
Weight change
Time frame: 6 months
Body fat
fat change
Time frame: 6 months
Systolic and diastolic blood pressures
blood pressure change
Time frame: 6 months
Lipid profile
Triglyceride
Time frame: 6 months
Insulin resistance
HOMA-IR
Time frame: 6 months
Plan to share: Undecided
No publications or documents are linked to this record.
This study is status unknown, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Empagliflozin
Seoul National University Bundang Hospital →