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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00871416

Enrollment

Registered

2009-03-30

Start date

1997-04-09

Completion date

1997-07-18

Last updated

2017-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

DEVICENovoFine® needle 6 mm

DEVICENovoFine® needle 12 mm

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame
Location of the injected sterile, atmospheric air	after 4 injections at visit 1 and 2, respectively

Secondary

Measure	Time frame
Cutis/subcutis thickness on 14 recommended injection sites	—

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026