Et randomiseret, dobbeltblindet, placebokontrolleret cross-over forsøg med Hexalacton til patienter med type 1 diabetes og mikroalbuminuri.

INTERVENTION: Trade Name: Hexalacton Product Name: Hexalacton Pharmaceutical Form: Tablet INN or Proposed INN: SPIRONOLACTONE CAS Number: 52017 Concentration unit: mg milligram(s) Concentration number: 25‐ Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use CONDITION: Diabetes Mellitus type 1. Patients with microalbuminuria (protein in urine due to diabetic kidney damage). ; MedDRA version: 9.1 Level: LLT Classification code 10045228 Term: Type I diabetes mellitus PRIMARY OUTCOME: Main Objective: To evaluate the effect of Hexalacton(R) on microalbuminuria in patients with diabetes and microalbuminuria. Primary end point(s): Albuminuria: changing to lower or even normal level (<30 mg/24 hour); Secondary Objective: Changes in kidney function (evaluated with GFR‐measurement) and 24 hour blood pressure. INCLUSION CRITERIA: Diabetes Mellitus, type 1 Microalbuminuria Fertile women shall use contraception 18‐80 years old men and women 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 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range