NCT00871416

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at below P25 for phase_3 diabetes

Timeline
Completed

Started Apr 1997

Shorter than P25 for phase_3 diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 9, 1997

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 18, 1997

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 18, 1997

Completed
11.7 years until next milestone

First Submitted

Initial submission to the registry

March 27, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 30, 2009

Completed
Last Updated

February 28, 2017

Status Verified

February 1, 2017

Enrollment Period

3 months

First QC Date

March 27, 2009

Last Update Submit

February 27, 2017

Conditions

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

Outcome Measures

Primary Outcomes (1)

  • Location of the injected sterile, atmospheric air

    after 4 injections at visit 1 and 2, respectively

Secondary Outcomes (1)

  • Cutis/subcutis thickness on 14 recommended injection sites

Interventions

NovoFine® needle 6 mmDEVICE
Also known as: NEEDLEN
NovoFine® needle 12 mmDEVICE
Also known as: NEEDLEN

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Pregnancy or plans thereof
  • Local reactions on injection sites
  • Acute, severe infection diseases
  • Coagulation disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novo Nordisk Investigational Site

Aarhus, 8000, Denmark

Location

Related Links

MeSH Terms

Conditions

Diabetes MellitusDiabetes Mellitus, Type 1Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Global Clinical Registry (GCR, 1452)

    Novo Nordisk A/S

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 27, 2009

First Posted

March 30, 2009

Study Start

April 9, 1997

Primary Completion

July 18, 1997

Study Completion

July 18, 1997

Last Updated

February 28, 2017

Record last verified: 2017-02

Locations

DK(1)