Comparison of Two Pen Systems in Patients With Diabetes Treated With Insulin

This study has been completed.

Sponsored by:	Novo Nordisk
Information provided by:	Novo Nordisk
ClinicalTrials.gov Identifier:	NCT00569998

Purpose

This trial is conducted in Europe. The aim of this trial is to compare two insulin delivery pens in the everyday life setting of patients with diabetes treated with insulin.

Condition	Intervention	Phase
Diabetes Mellitus	Device: NovoPenTM 4 Device: NovoPen® 3	Phase III

MedlinePlus related topics: Diabetes

Drug Information available for: Insulin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Safety/Efficacy Study
Official Title:	Evaluation of Preference, Performance, Acceptance, Handling and Safety of NovoPenTM 4 Versus NovoPen® 3 in Patients With Diabetes Treated With Insulin

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:

Evaluation of overall pen preference [ Time Frame: after 12 weeks of treatement ]

Secondary Outcome Measures:

HbA1c
Adverse device effects
Adverse events

Estimated Enrollment:	200
Study Start Date:	August 2003

Eligibility

Ages Eligible for Study:	9 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Type 1 or type 2 diabetes mellitus for at least 12 months
Adults at least 18 years
Children/adolescents between 9-18 years
HbA1c lesser than or equal to 11.0%

Exclusion Criteria:

Known or suspected alcohol or drug abuse
Patients who are not able to read the user manual (may wear glasses if needed)
Hypoglycaemic unawareness as judged by the investigator
Visual and/or dexterity impairments as judged by the investigator

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00569998

Locations

Austria

Wien, Austria, 1090
Germany

Leverkusen, Germany, 51373
Italy, to

TORINO, to, Italy, 10144
Netherlands

Rotterdam, Netherlands, 3015 GD
United Kingdom

Belfast, United Kingdom, BT37 9RH

Sponsors and Collaborators

Novo Nordisk

Investigators

Study Director:

Lene Lytzen, DDS

Novo Nordisk

More Information

Clinical Trials at Novo Nordisk This link exits the ClinicalTrials.gov site

Responsible Party:	Novo Nordisk A/S ( Public Access to Clinical Trials )
Study ID Numbers:	MS236-1544
Study First Received:	December 4, 2007
Last Updated:	November 25, 2008
ClinicalTrials.gov Identifier:	NCT00569998
Health Authority:	Austria: Federal Ministry for Health and Women; Germany: German Agency of Medicines; United Kingdom: Medicines and Healthcare Products Regulatory; Italy: The Italian Medicines Agency; Netherlands: Dutch Health Care Inspectorate

Study placed in the following topic categories:

Metabolic Diseases
Diabetes Mellitus
Endocrine System Diseases
Endocrinopathy

Metabolic disorder
Glucose Metabolism Disorders
Insulin

ClinicalTrials.gov processed this record on January 15, 2009