| Inclusion criteria |
Written informed consent must be provided before participation. Patient information and consent form must be approved by relevant IEC. Specifically, all participating patients will be asked to give informed consent for long-term follow-up Male or female with age ≥18 years and <75 years Diagnosed with type 2 DM (WHO criteria) Persistent normoalbuminuria (at least 2 of 3 UACR <30 mg/g samples from ‘run in’-period) eGFR >45 mL/min/1.73 m2 at screening visit HbA1c ≥6.5% (48 mmol/mol) and <13% (119 mmol/mol) at screening visit The patient must be willing and able to comply with the protocol for the duration of the study Female without childbearing potential at the screening visit. Defined as one or more of following:
Female patients ≥50 years of age on the day of inclusion, who have been postmenopausal for at least 1 year Female patients <50 years of age at the day of inclusion, who have been postmenopausal for at least 1 year and serum FSH levels >40 mIU/mL as well as serum oestrogen levels <30 pg/mL or a negative oestrogen test 6 weeks after surgical sterilisation by bilateral tubal ligation or bilateral ovariectomy with or without hysterectomy
OR a negative urine pregnancy test at the screening visit AND one or more of following:
Correct use of reliable contraception methods. This includes one or more of the following: hormonal contraceptive (such as injection, transdermal patch, implant, cervical ring or oral) or an intrauterine device OR correct use of double barrier with one of the following: barrier methods (diaphragm, cervical cap, Lea contraceptive, femidom or condom) AND in combination with a spermicide General sexual abstinence from the time of screening/during the study until a minimum of 30 days after the last administration of study medication if this is already established as the patient's preferred and usual lifestyle Having only female sexual partners Sexual relationship with sterile male partners only
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| Exclusion criteria |
Average of systolic BP <110 or >160 mm Hg at baseline Average of diastolic BP >100 mm Hg at baseline Type 1 DM (WHO criteria) Current in treatment with more than one RAAS blocking agent (ACEI, ARB or direct renin inhibitor) Current lithium treatment. Known or suspected hypersensitivity to spironolactone or to any of its excipients. Current use of potassium sparing diuretics, such as: spironolactone, eplerenone or amiloride etc Screening (week-6) plasma (or serum) potassium level >5.0 mmol/L Hypernatraemia determine by the investigator Current cancer treatment or within 5 years from baseline (except basal cell skin cancer or squamous cell skin cancer) Any clinically significant disorder, except for conditions associated with type 2 DM history, which in the Investigators opinion could interfere with the results of the trial. Cardiac disease defined as: heart failure (NYHA class III–IV) and/or diagnosis of unstable angina pectoris and/or MI, stroke, PTCA or CABG within the last 3 months. Body mass index <18.5 or >40 kg/m2 Diagnosis of non-diabetic CKD current or in the past Diagnosis of liver cirrhosis with current impaired liver function within the last 3 years Diagnosis of Addison’s disease Being lactating Intend to become pregnant within the duration of the study or not use adequate birth control Known or suspected abuse of alcohol or narcotics Not able to understand informed consent form Participation in any other intervention trial than PRIORITY or a related substudy is not allowed within 30 days before inclusion or concurrent to this study
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