Clinical trial NCT00569998: Comparison of Two Pen Systems in Patients With Diabetes Treated With Insulin
Official title: An Open-label, Multi-centre, Multi-national, Comparative, Randomised, Cross-over Trial Evaluating Preference as Well as Performance, Acceptance, Handling and Safety of NovoPen™ 4 (MS236) Versus NovoPen 3® in Insulin Treated Diabetic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Delivery Systems
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2007-12-10
Enrollment: 208
Sex: ALL
Minimum age (years): 9
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Evaluation of overall pen preference
timeFrame: after 12 weeks of treatment
Secondary outcomes:
measure: HbA1c
measure: Adverse device effects
measure: Adverse events
Other outcomes:
Locations:
city: Wien
country: Austria
facility: Novo Nordisk Investigational Site
city: Wien
country: Austria
facility: Novo Nordisk Investigational Site
city: Köln
country: Germany
facility: Novo Nordisk Investigational Site
city: Leverkusen
country: Germany
facility: Novo Nordisk Investigational Site
city: München
country: Germany
facility: Novo Nordisk Investigational Site
city: Speyer
country: Germany
facility: Novo Nordisk Investigational Site
city: St. Ingbert
country: Germany
facility: Novo Nordisk Investigational Site
city: Völklingen
country: Germany
facility: Novo Nordisk Investigational Site
city: Catania
country: Italy
facility: Novo Nordisk Investigational Site
city: Palermo
country: Italy
facility: Novo Nordisk Investigational Site
city: Parma
country: Italy
facility: Novo Nordisk Investigational Site
city: Roma
country: Italy
facility: Novo Nordisk Investigational Site
city: Torino
country: Italy
facility: Novo Nordisk Investigational Site
city: Almere
country: Netherlands
facility: Novo Nordisk Investigational Site
city: Amsterdam
country: Netherlands
facility: Novo Nordisk Investigational Site
city: Den Haag
country: Netherlands
facility: Novo Nordisk Investigational Site
city: Heerlen
country: Netherlands
facility: Novo Nordisk Investigational Site
city: Rotterdam
country: Netherlands
facility: Novo Nordisk Investigational Site
city: Veldhoven
country: Netherlands
facility: Novo Nordisk Investigational Site
city: Belfast
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Belfast
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Leeds
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Sidcup
country: United Kingdom
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Kolaczynski M, Chayer D. NovoPen® 4: perceived as superior in handling and acceptance versus HumaPen® Ergo and OptiPen® Pro in patients and healthcare professionals. Diabetes Technology &amp; Therapeutics 2005; 7 (2): 390
citation: Goke B, Gamba S, Erdtsieck RJ, Gilbey S, Schober E, Lytzen L, Kolaczynski M. NovoPen 4 offers superior performance, handling and acceptance compared with NovoPen 3 in insulin-treated diabetes patients. Diabetes Technology and Therapeutics 2005; 7 (2): 379-380