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

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00871416
First received: March 27, 2009
Last updated: June 28, 2012
Last verified: June 2012
  Purpose

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 Intervention 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
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Location of the injected sterile, atmospheric air [ Time Frame: after 4 injections at visit 1 and 2, respectively ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cutis/subcutis thickness on 14 recommended injection sites [ Designated as safety issue: No ]

Enrollment: 48
Study Start Date: April 1997
Study Completion Date: July 1997
Primary Completion Date: July 1997 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: NovoFine® needle 6 mm
    Other Name: NEEDLEN
    Device: NovoFine® needle 12 mm
    Other Name: NEEDLEN
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00871416

Locations
Denmark
Århus, Denmark, 8000
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Lene Lytzen, DDS Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00871416     History of Changes
Other Study ID Numbers: NEEDLEN/DCD/3/DK
Study First Received: March 27, 2009
Last Updated: June 28, 2012
Health Authority: Denmark: Danish Medicines Agency

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on August 18, 2014