Back to resultsLocalisation of Potential Insulin Deposits in Normal Weight and Obese Diabetics Using 6 mm and 12 mm Long Needles
Primary Purpose
Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
Status
Completed
Phase
Phase 3
Locations
Denmark
Study Type
Interventional
Intervention
NovoFine® needle 6 mm
NovoFine® needle 12 mm
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes
Eligibility 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
Sites / Locations
- Novo Nordisk Investigational Site
Outcomes
Primary Outcome Measures
Location of the injected sterile, atmospheric air
Secondary Outcome Measures
Cutis/subcutis thickness on 14 recommended injection sites
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00871416
Brief Title
Localisation of Potential Insulin Deposits in Normal Weight and Obese Diabetics Using 6 mm and 12 mm Long Needles
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
April 9, 1997 (Actual)
Primary Completion Date
July 18, 1997 (Actual)
Study Completion Date
July 18, 1997 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Delivery Systems
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
NovoFine® needle 6 mm
Other Intervention Name(s)
NEEDLEN
Intervention Type
Device
Intervention Name(s)
NovoFine® needle 12 mm
Other Intervention Name(s)
NEEDLEN
Primary Outcome Measure Information:
Title
Location of the injected sterile, atmospheric air
Time Frame
after 4 injections at visit 1 and 2, respectively
Secondary Outcome Measure Information:
Title
Cutis/subcutis thickness on 14 recommended injection sites
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Registry (GCR, 1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Århus
ZIP/Postal Code
8000
Country
Denmark
12. IPD Sharing Statement
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk
Learn more about this trial
Localisation of Potential Insulin Deposits in Normal Weight and Obese Diabetics Using 6 mm and 12 mm Long Needles
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