Localisation of Potential Insulin Deposits in Normal Weight and Obese Diabetics Using 6 mm and 12 mm Long Needles
Sponsor
Novo Nordisk A/S (Industry)
Overall Status
Completed
CT.gov ID
NCT00871416
Collaborator
(none)
48
1
3.3
14.6
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
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
:
Apr 9, 1997
Actual Primary Completion Date
:
Jul 18, 1997
Actual Study Completion Date
:
Jul 18, 1997
Outcome Measures
Primary Outcome Measures
- Location of the injected sterile, atmospheric air [after 4 injections at visit 1 and 2, respectively]
Secondary Outcome Measures
- Cutis/subcutis thickness on 14 recommended injection sites []
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | 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
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00871416
Other Study ID Numbers:
- NEEDLEN/DCD/3/DK
First Posted:
Mar 30, 2009
Last Update Posted:
Feb 28, 2017
Last Verified:
Feb 1, 2017
Additional relevant MeSH terms: