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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 (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00871416
First received: March 27, 2009
Last updated: February 27, 2017
Last verified: February 2017
  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
Intervention Model: Crossover Assignment
Masking: No masking
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 ]

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

Enrollment: 48
Actual Study Start Date: April 9, 1997
Study Completion Date: July 18, 1997
Primary Completion Date: July 18, 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   (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
  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
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
  More Information

Additional Information:
Responsible Party: 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: February 27, 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

ClinicalTrials.gov processed this record on April 26, 2017