Empagliflozin as a Modulator of Systemic Vascular Resistance and Cardiac Output in Patients With Type 2 Diabetes

Sponsor
RWTH Aachen University
Study ID
NCT03132181
Phase
PHASE2
Status
Completed

Conditions

  • Diabetes Mellitus Type 2 (T2DM)

Eligibility Criteria

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

Interventions

  • Empagliflozin — DRUG
    Patient will be treaded according to standard care but additionally take one tablet Empagliflozin per day
  • Placebo — OTHER
    Patient will be treaded according to standard care but additionally take one tablet placebo per day

Study Details

SGLT2 inhibitors are a novel class of glucose lowering drugs that act in the kidney by inhibiting SGLT2-mediated glucose reabsorption in the proximal tubule. The resulting increase in urinary glucose excretion leads to a reduction in plasma glucose levels. This is accompanied by reduction of total body weight due to urinary energy loss. In addition, glucose dependent osmotic diuresis contributes to blood pressure lowering effects of SGLT2 inhibition. Aim of the trial is to assess hemodynamic changes by empagliflozin, identify new empagliflozin dependent metabolic regulators and evaluate empagliflozin dependent effects on cardiac function.

Key Dates

Start date
Apr 24, 2017
Status verified
Feb 2019
Primary completion
Jan 23, 2019
Completion
Jan 23, 2019

Study Design

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

Arms

  • Experimental: Empagliofizin
    Patients will receive empagliflozin 10 mg qd for a period of 3 months.
  • Placebo Comparator: Placebo
    Patients of the placebo arm will receive placebo tablets qd for a period of 3 months.

Primary Outcome Measure

Mode of action [ Time Frame: 3 months ]

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