Metabolic Effects of the SGLT-2 Inhibitor Empagliflozin in Patients With Diabetic Nephropathy (MEDiaN)

Sponsor
Singapore General Hospital
Study ID
NCT03933956
Phase
PHASE3
Status
Terminated

Conditions

  • Diabetic Nephropathies

Eligibility Criteria

Sex
ALL
Age
21 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

The MEDiaN study aims to examine the state of fuel metabolism in participants with diabetic nephropathy (DN) before and after the use of the sodium-glucose transport protein 2 inhibitor (SGLT-2i) empagliflozin. The goals of the MEDiaN study are to better understand the contribution of fuel metabolism to the development of DN, and to determine if changes to fuel metabolism can have a positive impact on this disease. The MEDiaN study is a single-center single-arm open-label intervention study to examine the effects of empagliflozin 10mg daily taken for 30 days on fuel oxidation patterns in participants with type 2 diabetes and DN.

Key Dates

Start date
Jan 9, 2020
Status verified
Dec 2020
Primary completion
Aug 1, 2020
Completion
Aug 1, 2020

Study Design

Enrollment
2 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Empagliflozin-treated
    Oral empagliflozin tablets 10mg daily, taken for 30 days.

Primary Outcome Measure

Change in lipid metabolome signature [ Time Frame: Baseline and after 30 days of treatment with empagliflozin 10mg daily ]

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