Diabetes Mellitus, Type 2 Clinical Trial
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
| Verified date | January 2017 |
| Source | Novo Nordisk A/S |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 208 |
| Est. completion date | February 2004 |
| Est. primary completion date | February 2004 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 9 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Austria | Novo Nordisk Investigational Site | Wien | |
| Austria | Novo Nordisk Investigational Site | Wien | |
| Germany | Novo Nordisk Investigational Site | Köln | |
| Germany | Novo Nordisk Investigational Site | Leverkusen | |
| Germany | Novo Nordisk Investigational Site | München | |
| Germany | Novo Nordisk Investigational Site | Speyer | |
| Germany | Novo Nordisk Investigational Site | St. Ingbert | |
| Germany | Novo Nordisk Investigational Site | Völklingen | |
| Italy | Novo Nordisk Investigational Site | Catania | |
| Italy | Novo Nordisk Investigational Site | Palermo | |
| Italy | Novo Nordisk Investigational Site | Parma | |
| Italy | Novo Nordisk Investigational Site | Roma | |
| Italy | Novo Nordisk Investigational Site | Torino | |
| Netherlands | Novo Nordisk Investigational Site | Almere | |
| Netherlands | Novo Nordisk Investigational Site | Amsterdam | |
| Netherlands | Novo Nordisk Investigational Site | Den Haag | |
| Netherlands | Novo Nordisk Investigational Site | Heerlen | |
| Netherlands | Novo Nordisk Investigational Site | Rotterdam | |
| Netherlands | Novo Nordisk Investigational Site | Veldhoven | |
| United Kingdom | Novo Nordisk Investigational Site | Belfast | |
| United Kingdom | Novo Nordisk Investigational Site | Belfast | |
| United Kingdom | Novo Nordisk Investigational Site | Leeds | |
| United Kingdom | Novo Nordisk Investigational Site | Sidcup |
| Lead Sponsor | Collaborator |
|---|---|
| Novo Nordisk A/S |
Austria, Germany, Italy, Netherlands, United Kingdom,
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
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 & Therapeutics 2005; 7 (2): 390
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Evaluation of overall pen preference | after 12 weeks of treatment | ||
| Secondary | HbA1c | |||
| Secondary | Adverse device effects | |||
| Secondary | Adverse events |
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