NL-OMON49031
Completed
Phase 4
A phase 4, monocenter, randomized, double-blind, placebo-controlled, 4-armed cross-over mechanistic intervention study to assess the renal hemodynamic effect of mono- and combination therapy with empagliflozin (SGLT-2 inhibitor) and losartan (RAS inhibitor) in metformin and/or SU-treated patients with type 2 diabetes mellitus - RECOLAR: Renohemodynamic Effects of Combined empagliflOzin and LosARtan
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- 10029149
- Sponsor
- Vrije Universiteit Medisch Centrum
- Enrollment
- 24
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\* Caucasian, Asian or Middle Eastern (sub\-Saharan patients are not eligible);
- •\* Both genders (females must be post\-menopausal; no menses \>1 year; in case of
- •doubt, Follicle\-Stimulating Hormone (FSH) will be determined with cut\-off
- •defined as \>31 U/L)
- •\* Age: 45 \- 80 years
- •\* BMI: \>25 kg/m2
- •\* HbA1c: 6\.5 \* 10\.5% Diabetes Control and Complications Trial (DCCT) or 48 \- 91
- •mmol/mol International Federation of Clinical Chemistry (IFCC)
- •\* Treatment with a stable dose of metformin and/or SU therapy for at least 3
- •months prior to inclusion
Exclusion Criteria
- •\* History of unstable or rapidly progressing renal disease
- •\* Macroalbuminuria; defined as ACR of 300mg/g.
- •\* Estimated GFR \<60 mL/min/1\.73m2 (determined by the Modification of Diet in
- •Renal Disease (CKD\-EPI) study equation)
- •\* Only use of alpha blockers and/or beta blockers are allowed as
- •antihypertensive background therapy. Patients using an antihypertensive agent
- •will be considered if this agent can be stopped (i.e. blood pressure adequate
- •to stop at screening) or replaced by an alpha or beta blocker. In these
- •patients, a 4 week wash\-out/run\-in period will be observed prior to visit 2\.
- •\* Current/chronic use of the following medication: SGLT2 inhibitors, RAS
Outcomes
Primary Outcomes
Not specified
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