Renohemodynamic Effects empaGliflozin in vaRiOUs Populations
- Conditions
- Diabetes Mellitus type 2Therapeutic area: Diseases [C] - Hormonal diseases [C19]
- Registration Number
- EUCTR2020-000165-16-NL
- Lead Sponsor
- Amsterdam University Medical Center - location VU Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 72
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: 45 - 80 years
• BMI: >25 kg/m2
• For with people with diabetes - a diagnosis of T2DM with glycosylated haemoglobin (HbA1c) =6.5% (=48 mmol/mol) and <10.5% (<91 mmol/mol); and eGFR (CKD-EPI) between =25 and =50 mL/min/1.73m2 or >75 mL/min/1.73m2 at the Screening Visit (Visit 1).
• In the normoglycemic, hypertensive, individuals: HbA1c <6.5% (<48 mmol/mol) and an eGFR (CKD-EPI) between =25 and =50 mL/min/1.73m2 at the Screening Visit (Visit 1).
• In the diabetic arm: people with an eGFR >75 ml/min/1.73m2 should be treated with a stable dose of metformin and/or SU, people with an eGFR between =25 and =50 mL/min/1.73m2 should be treated with a stable dose of metformin, SU and/or insulin therapy for at least 3 months prior to inclusion
• Patient specific antihypertensive dose of an angiotensin receptor blocker (ARB) (as per Investigator’s judgement) for at least 4 weeks prior to Visit 2 (Day 3).
• 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
F.1.2.1 Number of subjects for this age range 36
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 36
History of unstable or rapidly progressing renal disease
• Diagnosis of polycystic kidney disease.
• Post renal transplant
• History of or current lupus nephritis.
• Abnormal vital signs, after 10 minutes supine rest, definas as any of the following (Visit 1):
o Systolic blood pressure above 180 mmHg
o Diastolic blood pressure above 110 mmHg
• Current/chronic use of the following medication: SGLT2 inhibitors,TZD, GLP-1RA, DPP-4 inhibitors, , antimicrobial agents or chemotherapeutics.
• 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 (<3 months) history of cardiovascular disease, including:
o Acute coronary syndrome
o Chronic heart failure (New York Heart Association grade II-IV)
o Stroke or transient ischemic neurologic disorder
• Complaints compatible with neurogenic bladder and/or incomplete bladder emptying (as determined by ultrasonic bladder scan)
• Severe hepatic insufficiency and/or significant abnormal liver function defined as aspartate aminotransferase (AST) >3x upper limit of normal (ULN) and/or alanine aminotransferase (ALT) >3x ULN
• History of or actual malignancy (except basal cell carcinoma)
• History of or actual severe mental disease
• Substance abuse (alcohol: defined as >4 units/day)
• Allergy to any of the agents used in the study
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method