Empagliflozin and ACEi- Effects on Hyperfiltration: BETWEEN Study

Sponsor
Boehringer Ingelheim
Study ID
NCT02632747
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

Study Details

This is a randomized, double-blind, double-dummy, placebo-controlled, cross over design trial with empagliflozin compared to placebo that is added to open-label ramipril.

Key Dates

Start date
May 10, 2016
Status verified
Jul 2020
Primary completion
Dec 19, 2017
Completion
Jul 2, 2019

Study Design

Enrollment
31 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Sequence A
    Empagliflozin followed by a wash-out followed by empagliflozin matching placebo on a background of open label ramipril.
  • Experimental: Sequence B
    Empagliflozin matching placebo followed a wash-out followed by empagliflozin on a background of open label ramipril.

Primary Outcome Measure

Glomerular Filtration Rate (GFR) Under Euglycaemic Conditions After 4 Weeks of Treatment With Either Empagliflozin Added to Ramipril or Placebo Added to Ramipril. [ Time Frame: At week 4 and at week 12 ]

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