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

• Sponsor: Novo Nordisk A/S (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00806858
• Collaborator: (none)
• Enrollment: 526
• Location: 1
• Duration (Months): 8
• Patients Per Site Per Month: 66.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Delivery Systems	Device: NovoPen® 4

Study Design

• Study Type: Observational
• Actual Enrollment: 526 participants
• Time Perspective: Prospective
• 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
• Study Start Date: Nov 1, 2008
• Actual Primary Completion Date: Jul 1, 2009
• Actual Study Completion Date: Jul 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
A	Device: NovoPen® 4; Insulin administration by means of a NovoPen® 4 pen device

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

1. Subjects' device preference [3 months]

2. Subjects' NovoPen® 4 evaluation [3 months]

3. Number of clinical technical complaints [3 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novo Nordisk Investigational Site	Beijing	Beijing	China	100004

Sponsors and Collaborators

• Novo Nordisk A/S

Investigators

• Study Director: Global Clinical Registry (GCR, 1452), Novo Nordisk A/S

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Clinical Trials at Novo Nordisk

Publications

None provided.

• Responsible Party: Novo Nordisk A/S
• ClinicalTrials.gov Identifier: NCT00806858
• Other Study ID Numbers: MS236-3663
• First Posted: Dec 11, 2008
• Last Update Posted: Nov 23, 2016
• Last Verified: Nov 1, 2016

• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1

Study Results

No Results Posted as of Nov 23, 2016