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Completed

NCT Number: NCT00871416

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

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.

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Key information

Conditions

Diabetes Autoimmune Diseases Delivery Systems Diabetes Mellitus Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Novo Nordisk Investigational Site

Aarhus, 8000, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NovoFine® needle 6 mm

Device

Other names: NEEDLEN

NovoFine® needle 12 mm

Device

Other names: NEEDLEN

Primary outcomes

  1. Location of the injected sterile, atmospheric air

    Time frame: after 4 injections at visit 1 and 2, respectively

Secondary outcomes

  1. Cutis/subcutis thickness on 14 recommended injection sites

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

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

Important dates

Study start
1997
Primary completion
1997
Study completion
1997
First posted
Mar 30, 2009
Registry last updated
Feb 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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