NCT00806858

Brief Summary

This study is conducted in Asia. The aim of this observational study is to evaluate subjects' treatment satisfaction and to evaluate subjects' preference of pen device and the incidence of clinical technical complains while using NovoPen® 4 under normal clinical practice conditions.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
526

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2008

Shorter than P25 for all trials

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

November 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 10, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 11, 2008

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

November 23, 2016

Status Verified

November 1, 2016

Enrollment Period

8 months

First QC Date

December 10, 2008

Last Update Submit

November 22, 2016

Conditions

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

Outcome Measures

Primary Outcomes (1)

  • The change in subjects' satisfaction with insulin therapy, measured by change from visit 1 to visit 2 in subject treatment satisfaction scores on the DTSQ (Diabetes Treatment Satisfaction Questionnaire)

    3 months

Secondary Outcomes (3)

  • Subjects' device preference

    3 months

  • Subjects' NovoPen® 4 evaluation

    3 months

  • Number of clinical technical complaints

    3 months

Study Arms (1)

A

Device: NovoPen® 4

Interventions

NovoPen® 4DEVICE

Insulin administration by means of a NovoPen® 4 pen device

A

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Any subject with Type 1 or Type 2 diabetes

You may qualify if:

  • Any subject with Type 1 or Type 2 diabetes and accepting to use NovoPen® 4. The selection will be at the discretion of the individual physician.
  • A study specific signed informed consent must be signed by each subject before any study-related activities or information is collected, if required by local regulations

You may not qualify if:

  • Subjects who are unlikely to comply with the protocol, e.g., unwillingness to cooperate, inability to return for the final visit
  • Subjects with known or suspected allergy to any insulin or any of its excipients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novo Nordisk Investigational Site

Beijing, Beijing Municipality, 100004, China

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
observational
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 10, 2008

First Posted

December 11, 2008

Study Start

November 1, 2008

Primary Completion

July 1, 2009

Study Completion

July 1, 2009

Last Updated

November 23, 2016

Record last verified: 2016-11

Locations

CN(1)