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

ClinicalTrials.gov Identifier:

NCT00871416

First received: March 27, 2009

Last updated: June 28, 2012

Last verified: June 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

March 27, 2009

Last Updated Date

June 28, 2012

Start Date ^ICMJE

April 1997

Primary Completion Date

July 1997 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00871416 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Diabetes
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Delivery Systems

Intervention ^ICMJE

Device: NovoFine® needle 6 mm
Other Name: NEEDLEN
Device: NovoFine® needle 12 mm
Other Name: NEEDLEN

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

July 1997

Primary Completion Date

July 1997 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Denmark

Administrative Information

NCT Number ^ICMJE

NCT00871416

Other Study ID Numbers ^ICMJE

NEEDLEN/DCD/3/DK

Has Data Monitoring Committee

Responsible Party

Public Access to Clinical Trials, Novo Nordisk A/S

Study Sponsor ^ICMJE

Novo Nordisk

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Lene Lytzen, DDS

Novo Nordisk

Information Provided By

Novo Nordisk

Verification Date

June 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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