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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00806858
Enrollment
526
Registered
2008-12-11
Start date
2008-11-30
Completion date
2009-07-31
Last updated
2016-11-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

DEVICENovoPen® 4

Insulin administration by means of a NovoPen® 4 pen device

Sponsors

Novo Nordisk A/S
Lead SponsorINDUSTRY

Study design

Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Subjects' device preference3 months
Subjects' NovoPen® 4 evaluation3 months
Number of clinical technical complaints3 months

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026