Localisation of Potential Insulin Deposits in Normal Weight and Obese Diabetics Using 6 mm and 12 mm Long Needles

Novo Nordisk

Status and phase: Completed; Phase 3

Conditions: Diabetes Mellitus, Type 1; Diabetes; Diabetes Mellitus, Type 2; Delivery Systems

Treatments: Device: NovoFine® needle 6 mm; Device: NovoFine® needle 12 mm

Study type: Interventional

Funder types: Industry

Identifiers

NCT00871416

NEEDLEN/DCD/3/DK

Details and patient eligibility

About

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.

Enrollment: 48 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)