The renal actions of combined empagliflozin and linagliptin in type 2 diabetes
- Conditions
- Type 2 Diabetes MellitusTherapeutic area: Diseases [C] - Hormonal diseases [C19]
- Registration Number
- EUCTR2017-001547-12-NL
- Lead Sponsor
- VU University Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 66
•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 - 75 years
•BMI: >25 kg/m2
•HbA1c: 7.0 – 9.5% Diabetes Control and Complications Trial (DCCT) or 53 - 80 mmol/mol International Federation of Clinical Chemistry (IFCC)
•Treatment with a stable dose of metformin monotherapy for at least 3 months prior to inclusion
•Hypertension should be controlled, i.e. =140/90 mmHg, and treated with an ACE-I or ARB (unless prevented by side effect) for at least 3 months.
•Albuminuria should be treated with a RAAS-interfering agent (ACE-I or ARB) for at least 3 months.
•Written informed consent
* In order to increase homogeneity
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 44
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 22
•Estimated GFR <45 mL/min/1.73m2 (determined by the Modification of Diet in Renal Disease (MDRD) study equation)
•Current urinary tract infection and active nephritis
•History of unstable or rapidly progressing renal disease
•Macroalbuminuria; defined as ACR of 300 mg/g.
•Current/chronic use of the following medication: thiazolidinediones, sulfonylurea derivatives, GLP-1 receptor agonists, DPP-4 inhibitors, SGLT-2 inhibitor, oral glucocorticoids, immune suppressants, antimicrobial agents, chemotherapeutics, antipsychotics, tricyclic antidepressants (TCAs) and monoamine oxidase inhibitors (MOAIs).
•Patients on diuretics will only be excluded when these drugs cannot be stopped 3 months prior randomization and for the duration of the study.
•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 drugs can be taken within a time-frame of 2 weeks prior to renal-testing
•Pregnancy
•History of or actual severe mental disease
•History of or actual severe somatic disease (e.g. systemic disease)
•History of or actual malignancy (except basal cell carcinoma)
•History of or actual pancreatic disease
•(Unstable) thyroid disease
•Severe hepatic insufficiency and/or significant abnormal liver function defined as aspartate aminotransferase (AST) >3x upper limit of normal (ULN)
•Recent (<6 months) history of cardiovascular disease, including
oAcute coronary syndrome
oStroke or transient ischemic neurologic disorder or chronic heart failure (NYHA grade II-IV)
•Complaints compatible with or established neurogenic bladder and/or incomplete bladder emptying (as determined by ultrasonic bladder scan)
•Substance abuse (alcohol: defined as >3 units alcohol/day)
•History of diabetic ketoacidosis (DKA) requiring medical intervention (e.g., emergency room visit and/or hospitalization) within 1 month prior to the Screening visit.
•Recent blood donation (< 6 months)
•Allergy to any of the agents used in the study
•Inability to understand the protocol and/or give informed consent
•Individuals who are investigator site personnel, directly affiliated with the study, or are immediate (spouse, parent, child, or sibling, whether biological or legally adopted) family of investigator site personnel directly affiliated with 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