EUCTR2019-003141-15-NL
Active, not recruiting
Phase 1
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
Amsterdam University Medical Center - location VU Medical Center0 sites24 target enrollmentJune 17, 2020
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Diabetes Mellitus type 2
- Sponsor
- Amsterdam University Medical Center - location VU Medical Center
- Enrollment
- 24
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Caucasian\*
- •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: 35 \- 80 years
- •BMI: \>25 kg/m2
- •HbA1c: 6\.5 – 10\.0% Diabetes Control and Complications Trial (DCCT) or 48 \- 86 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
- •Written informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
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 and/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 inhibitors, TZD, GLP\-1RA, DPP\-4 inhibitors, glucocorticoids, immune suppressants, antimicrobial agents, chemotherapeutics, antipsychotics, tricyclic antidepressants (TCAs) and monoamine oxidase inhibitors (MAOIs). Subjects on diuretics will only be excluded when these drugs cannot be stopped for the duration of the study.
- •Volume depleted patients. Patients at risk for volume depletion due to co\-existing conditions or concomitant medications, such as loop diuretics should have careful monitoring of their volume status.
- •Chronic use of non\-steroidal anti\-inflammatory drugs (NSAIDs) will not be allowed, unless used as incidental medication (1\-2 tablets) for non\-chronic indications (i.e. sports injury, head\-ache or back ache). However, no such drug can be taken within a time\-frame of 2 weeks prior to renal\-testing
- •History of diabetic ketoacidosis (DKA) requiring medical intervention (e.g. emergency room visit and/or hospitalization) within 1 month prior to the Screening visit.
- •Current urinary tract infection and active nephritis
- •Recent (\<6 months) history of cardiovascular disease, including:
Outcomes
Primary Outcomes
Not specified
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