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

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ClinicalTrials.gov Identifier: NCT00871416
Recruitment Status : Completed
First Posted : March 30, 2009
Last Update Posted : February 28, 2017
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

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.

Condition or disease Intervention/treatment Phase
Diabetes Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Delivery Systems Device: NovoFine® needle 6 mm Device: NovoFine® needle 12 mm Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : April 9, 1997
Primary Completion Date : July 18, 1997
Study Completion Date : July 18, 1997

Resource links provided by the National Library of Medicine

Drug Information available for: Insulin
U.S. FDA Resources


Intervention Details:
    Device: NovoFine® needle 6 mm
    Other Name: NEEDLEN
    Device: NovoFine® needle 12 mm
    Other Name: NEEDLEN


Primary Outcome Measures :
  1. Location of the injected sterile, atmospheric air [ Time Frame: after 4 injections at visit 1 and 2, respectively ]

Secondary Outcome Measures :
  1. Cutis/subcutis thickness on 14 recommended injection sites


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00871416


Locations
Denmark
Novo Nordisk Investigational Site
Århus, Denmark, 8000
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00871416     History of Changes
Other Study ID Numbers: NEEDLEN/DCD/3/DK
First Posted: March 30, 2009    Key Record Dates
Last Update Posted: February 28, 2017
Last Verified: February 2017

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs