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Comparison of NovoFine® Needles (4 mm vs. 6 mm)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00343343
Recruitment Status : Completed
First Posted : June 22, 2006
Last Update Posted : February 8, 2017
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Study Description
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Brief Summary:
This trial is conducted in Europe. The aim of this investigation is to explore the safety of a 4 mm needle compared to a 6 mm needle when injected in children and lean adults with diabetes.

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 4 mm Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Comparative, Randomised Study With NovoFine® 4 mm Needle Versus NovoFine® 6 mm Needle in Regard to Anatomical Deposition of Sterile Air in Children and Thin Adults With Diabetes and Backflow of Test Medium (Only Adults) After Injection in Thigh and Abdomen
Study Start Date : June 2006
Actual Primary Completion Date : August 2006
Actual Study Completion Date : August 2006

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Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Deposition of sterile air depositions.

Secondary Outcome Measures :
  1. Thickness of 1) dermis and 2) distance from skin surface to muscle fascia
  2. Amount of backflow

Eligibility Criteria
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Ages Eligible for Study:   6 Years to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Children
  • Type 1 diabetes
  • Insulin treatment for more than ½ year
  • BMI lesser than or equal to 19 kg/m2
  • Last HbA1c taken within the last year lesser than 10.5%
  • Girls: only prepubertal
  • Boys: both pre pubertal and pubertal. Adults
  • Type 1 and 2 diabetes
  • Insulin treatment for more than ½ year
  • BMI lesser than or equal to 23 kg/m2
  • Last HbA1c taken within the last year lesser than 10.5%

Exclusion Criteria:

  • Known or suspected allergy to trial product(s) or related products.
  • Pregnant, breast-feeding or the intention of becoming pregnant or not using adequate contraceptive measures (including country-specific adequate measures, if any).
  • Skin disease at abdomen and/or thigh
Contacts and Locations
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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): NCT00343343


Locations
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Denmark
Novo Nordisk Investigational Site
Ålborg, Denmark, 9100
Novo Nordisk Investigational Site
Århus C, Denmark, 8000
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
More Information
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Additional Information:

Publications of Results:

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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00343343    
Other Study ID Numbers: PDS322-1749
2006-000174-78 ( EudraCT Number )
First Posted: June 22, 2006    Key Record Dates
Last Update Posted: February 8, 2017
Last Verified: February 2017
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
 Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases