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
Conditions
Interventions
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-
Pharmace
Sponsors
Steno Diabetes Center
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
Exclusion criteria: allergy towards the medicine Pregnancy breat feeding alcohol or medicine abuse Blood pressure > 160/100 recent CABG plasma potassium>5.7 plasma creatinine changing>35 % from baseline to 14 days after treatment start (safety visit)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the effect of Hexalacton(R) on microalbuminuria in patients with diabetes and microalbuminuria. ;Secondary Objective: Changes in kidney function (evaluated with GFR-measurement) and 24 hour blood pressure.;Primary end point(s): Albuminuria: changing to lower or even normal level (<30 mg/24 hour) | — |
Countries
Denmark
Outcome results
None listed