Effects of Insulin Detemir and NPH Insulin on Renal Handling of Sodium, Fluid Retention, and Weight in Type 2 Diabetic Patients

• Status: Completed
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Hypothesis: Changing type 2 patients treatment from Insulin Insulatard to Insulin Detemir will increase their excretion of sodium in the urine and thereby decrease their extracellular volume and body weight. 24 patients are divided into 2 groups and their insulin treatment is shifted while their body composition, sodium excretion, weight and extracellular volume is monitored.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rigshospitalet, Denmark
• Treatments: Insulin; Insulin Detemir; Insulin, Globin Zinc; Insulin, Isophane; Isophane insulin, beef; Isophane Insulin, Human

Criteria

Inclusion Criteria:

• Type 2 diabetes according to WHO 1999 criteria for at least 3 month

• Insulin treated for at least 1 month

• BMI 25-40

• Age 18-80

• Hb1Ac < 10%

Exclusion Criteria:

• Hypertension not well regulated

• Serum creatinine > 130 micromol/l

• Non-diabetic kidney disease

• Disease that may cause invalid hgbA1c measurement

• Substance abuse

• Recent use of Detemir

• Pregnancy or risk of becoming pregnant

• Any condition that may disturb protocol adherence (language barrier etc) urinary albumin > 30 mg/24hours ( before screening)

• Use of drugs that may influence blood glucose (except oral antidiabetics)

• Use of drugs that may influence sodium balance,i.e diuretics ( tiazides accepted)

• Clinical significant disease that may influence outcome ( cancer etc)