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

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

Sponsors

Lead Sponsor: Novo Nordisk A/S

Source Novo Nordisk A/S
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.

Overall Status Completed
Start Date August 2003
Completion Date February 2004
Primary Completion Date February 2004
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Evaluation of overall pen preference after 12 weeks of treatment
Secondary Outcome
Measure Time Frame
HbA1c
Adverse device effects
Adverse events
Enrollment 208
Condition
Intervention

Intervention Type: Device

Intervention Name: NovoPen™ 4

Intervention Type: Device

Intervention Name: NovoPen® 3

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

Gender: All

Minimum Age: 9 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Global Clinical Registry (GCR, 1452) Study Director Novo Nordisk A/S
Location
Facility:
Novo Nordisk Investigational Site | Wien, 1090, Austria
Novo Nordisk Investigational Site | Wien, A 1090, Austria
Novo Nordisk Investigational Site | Köln, 50858, Germany
Novo Nordisk Investigational Site | Leverkusen, 51373, Germany
Novo Nordisk Investigational Site | München, 81377, Germany
Novo Nordisk Investigational Site | Speyer, 67346, Germany
Novo Nordisk Investigational Site | St. Ingbert, 66386, Germany
Novo Nordisk Investigational Site | Völklingen, 66333, Germany
Novo Nordisk Investigational Site | Catania, 95122, Italy
Novo Nordisk Investigational Site | Palermo, 90127, Italy
Novo Nordisk Investigational Site | Parma, 43100, Italy
Novo Nordisk Investigational Site | Roma, 00165, Italy
Novo Nordisk Investigational Site | Torino, 10144, Italy
Novo Nordisk Investigational Site | Almere, 1315 RA, Netherlands
Novo Nordisk Investigational Site | Amsterdam, 1081 HV, Netherlands
Novo Nordisk Investigational Site | Den Haag, 2512 VA, Netherlands
Novo Nordisk Investigational Site | Heerlen, 6419 PC, Netherlands
Novo Nordisk Investigational Site | Rotterdam, 3015 GD, Netherlands
Novo Nordisk Investigational Site | Veldhoven, 5504 DB, Netherlands
Novo Nordisk Investigational Site | Belfast, BT12 6BE, United Kingdom
Novo Nordisk Investigational Site | Belfast, BT37 9RH, United Kingdom
Novo Nordisk Investigational Site | Leeds, LS9 7TF, United Kingdom
Novo Nordisk Investigational Site | Sidcup, DA14 6LT, United Kingdom
Location Countries

Austria

Germany

Italy

Netherlands

United Kingdom

Verification Date

January 2017

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Study Design Info

Allocation: Randomized

Intervention Model: Crossover Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov