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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

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ClinicalTrials.gov Identifier: NCT00806858
Recruitment Status : Completed
First Posted : December 11, 2008
Last Update Posted : November 23, 2016
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

December 10, 2008
December 11, 2008
November 23, 2016
November 2008
July 2009   (Final data collection date for primary outcome measure)
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) [ Time Frame: 3 months ]
Same as current
Complete list of historical versions of study NCT00806858 on ClinicalTrials.gov Archive Site
  • Subjects' device preference [ Time Frame: 3 months ]
  • Subjects' NovoPen® 4 evaluation [ Time Frame: 3 months ]
  • Number of clinical technical complaints [ Time Frame: 3 months ]
Same as current
Not Provided
Not Provided
 
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
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.
Not Provided
Observational
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
Any subject with Type 1 or Type 2 diabetes
  • Diabetes
  • Diabetes Mellitus, Type 1
  • Diabetes Mellitus, Type 2
  • Delivery Systems
Device: NovoPen® 4
Insulin administration by means of a NovoPen® 4 pen device
A
Intervention: Device: NovoPen® 4
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
526
500
July 2009
July 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
China
 
 
NCT00806858
MS236-3663
No
Not Provided
Not Provided
Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
Novo Nordisk A/S
November 2016