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NCT00806858 Clinical Trial

Observational Study of NovoPen® 4 on Treatment Satisfaction of Insulin Therapy in Type 1 or Type 2 Subjects With Diabetes Mellitus

Diabetes Mellitus, Type 2 Clinical Trial

Official title:
NovoPen®4 Clinical Experience Programme: A Multicentre, Observational Study of NovoPen®4 on Treatment Satisfaction of Insulin Therapy in Type 1 or Type 2 Subjects With Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00806858
Other study ID # MS236-3663
Secondary ID
Status Completed
Phase N/A
First received December 10, 2008
Last updated November 22, 2016
Start date November 2008
Est. completion date July 2009

Study information
Verified date November 2016
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority China: Ministry of Health
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 526
Est. completion date July 2009
Est. primary completion date July 2009
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Device:
• NovoPen® 4
Insulin administration by means of a NovoPen® 4 pen device

Locations
Country Name City State
China Novo Nordisk Investigational Site Beijing Beijing

Sponsors (1)
Lead Sponsor Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 No
Secondary Subjects' device preference 3 months No
Secondary Subjects' NovoPen® 4 evaluation 3 months No
Secondary Number of clinical technical complaints 3 months Yes
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