Effect of Empagliflozin on Body Composition and Ketones

Seoul National University

Status and phase: Enrolling; Phase 4

Conditions: Fat; Intolerance, Pancreas; Diabetes Mellitus

Treatments: Drug: Hypoglycemics Oral; Drug: Empagliflozin 10 MG

Study type: Interventional

Funder types: Other

Identifiers

NCT03877406

B-1507/307-007

Details and patient eligibility

About

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).

Full description

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).

Enrollment: 200 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 2 patient groups

Control group

Active Comparator group

Description:

up-titration of standard medication including monotherapy or combination of Metformin, Sulfonylurea, DPP4 inhibitor

Treatment:

Drug: Hypoglycemics Oral

Study group

Experimental group

Description:

addition of empagliflozin 10mg qd on standard oral antihyperglycemic agents

Treatment:

Drug: Empagliflozin 10 MG