Applications Site Reactions After Injection of Insulin Detemir and Saline in Subjects With Diabetes
- Registration Number
- NCT00607737
- Lead Sponsor
- Lise Tarnow
- Brief Summary
To compare application site reactions after superficial and deep subcutaneous and intradermal injections of insulin detemir and saline in patients with diabetes
- The patient serves as his own control, n=100 patients with diabetes
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
- Diabetes mellitus
- HbA1c<11 %
- BMI: 20-35 kg/m2
- Insulin detemir naive
- Basal insulin dose>20E
Exclusion Criteria
- Known allergy to study drug
- Current steroid or antiallergic treatment
- Lipodystrophy
- Change in insulin and antihypertensive treatment < 30 days
- Smokers or alcoholics
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description 2 saline saline 1 insulin detemir insulin detemir
- Primary Outcome Measures
Name Time Method laser doppler blood flow 10 minutes - 7 days
- Secondary Outcome Measures
Name Time Method insulin detemir specific antibodies 3 months clinical signs 10 min - 7 days
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie insulin detemir-induced application site reactions in diabetic patients?
How does insulin detemir compare to other basal insulin analogs in terms of injection site safety profiles?
Are there specific biomarkers associated with increased risk of local reactions to insulin detemir?
What are the optimal injection techniques to minimize application site reactions with insulin detemir?
How do application site reactions of insulin detemir compare to those of intradermal insulin glargine in type 1 and type 2 diabetes?
Trial Locations
- Locations (1)
Steno Diabetes Center
🇩🇰Gentofte, Denmark
Steno Diabetes Center🇩🇰Gentofte, Denmark