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

Novo Nordisk A/S48 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Diabetes Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Delivery Systems

Interventions

NovoFine® needle 6 mmDEVICE

NovoFine® needle 12 mmDEVICE

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Novo Nordisk Investigational Site

Aarhus, Denmark

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

Data from ClinicalTrials.gov

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