Effect of Empagliflozin on Body Composition and Ketones

Sponsor
Seoul National University Bundang Hospital
Study ID
NCT03877406
Phase
PHASE4
Status
Unknown

Conditions

  • Diabetes Mellitus
  • Fat; Intolerance, Pancreas

Eligibility Criteria

Sex
ALL
Age
20 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Empagliflozin 10 MG — DRUG
    addition of empagliflozin 10 MG
  • Hypoglycemics Oral — DRUG
    dose escalation of hypoglycemics oral

Study Details

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).

Key Dates

Start date
Aug 1, 2018
Status verified
Aug 2023
Primary completion
Dec 31, 2023
Completion
Dec 31, 2023

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Control group
    up-titration of standard medication including monotherapy or combination of Metformin, Sulfonylurea, DPP4 inhibitor
  • Experimental: Study group
    addition of empagliflozin 10mg qd on standard oral antihyperglycemic agents

Primary Outcome Measure

HbA1c [ Time Frame: 6 months ]

Central Contacts

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