Status:
COMPLETED
Effects of Insulin Detemir and NPH Insulin on Renal Handling of Sodium, Fluid Retention, and Weight in Type 2 Diabetic Patients
Lead Sponsor:
Rigshospitalet, Denmark
Conditions:
Diabetes Type 2
Weight Gain
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief 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 ...
Detailed Description
Type 2 diabetic patients experience weight gain when receiving insulin treatment. There has been reports that the weight gain is less or absent when patients are treated with Insulin Detemir. Patients...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00742976
Start Date
June 1 2008
End Date
December 1 2009
Last Update
January 20 2010
Active Locations (1)
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1
Dept of Endocrinology, Rigshospitalet
Copenhagen, København Ø, Denmark, DK_2100