Effects of Empagliflozin on Liver Fat Content, Energy Metabolism and Body Composition in Patients With Type 2 Diabetes

Sponsor
The Deutsche Diabetes Forschungsgesellschaft e.V.
Study ID
NCT02637973
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

The effects of empagliflozin treatment on hepatocellular lipid content, liver energy metabolism and body composition will be investigated in a multicentre, prospective, placebo-controlled, double-blind, randomized, 2-arm parallel, interventional and exploratory pilot study in patients with newly diagnosed type 2 diabetes.

Key Dates

Start date
Dec 31, 2015
Status verified
Jun 2023
Primary completion
Aug 31, 2018
Completion
Aug 31, 2018

Study Design

Enrollment
84 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Empagliflozin
    Empagliflozin, film-tablet, 25mg once daily
  • Placebo Comparator: Placebo
    Placebo, once daily

Primary Outcome Measure

Change in liver fat content [ Time Frame: from baseline to 24 weeks ]

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