NCT00871416CompletedPhase 3
Localisation of Potential Insulin Deposits in Normal Weight and Obese Diabetics Using 6 mm and 12 mm Long Needles. Furthermore, the Thickness of Cutis/Subcutis Is Measured on Recommended Insulin Injection Sites
Conditions
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Novo Nordisk A/S
- Enrollment
- 48
- Locations
- 1
- Primary Endpoint
- Location of the injected sterile, atmospheric air
Study Overview
Brief Summary
This trial is conducted in Europe. The primary aim of this clinical trial is to locate and compare simulated insulin injections (injections of sterile atmospheric air) in normal weight and obese patients with diabetes mellitus. Injections are done with 6 mm and 12 mm needles with and without lifting of skin fold at different injection sites.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Diabetes mellitus
- •Use NovoPen®, NovoPen® 1.5, NovoPen® 3, NovoLet® 1.5 or NovoLet® 3 for at least 3 months
- •Body mass index (BMI) for normal weight between 19-25 kg/m2
- •Body mass index (BMI) for obese between 25-33 kg/m2
Exclusion Criteria
- •Pregnancy or plans thereof
- •Local reactions on injection sites
- •Acute, severe infection diseases
- •Coagulation disorders
Outcomes
Primary Outcomes
Location of the injected sterile, atmospheric air
Time Frame: after 4 injections at visit 1 and 2, respectively
Secondary Outcomes
- Cutis/subcutis thickness on 14 recommended injection sites
Investigators
Study Sites (1)
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