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Completed

NCT Number: NCT00806858

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.

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Key information

Conditions

Diabetes Autoimmune Diseases Delivery Systems Diabetes Mellitus Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Novo Nordisk Investigational Site

Beijing, Beijing Municipality, 100004, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NovoPen® 4

Device

Insulin administration by means of a NovoPen® 4 pen device

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)

    Time frame: 3 months

Secondary outcomes

  1. Subjects' device preference

    Time frame: 3 months

  2. Subjects' NovoPen® 4 evaluation

    Time frame: 3 months

  3. Number of clinical technical complaints

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Dec 11, 2008
Registry last updated
Nov 23, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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