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

Sponsor
Novo Nordisk A/S (Industry)
Overall Status
Completed
CT.gov ID
NCT00569998
Collaborator
(none)
208
Enrollment
23
Locations
6
Duration (Months)
9
Patients Per Site
1.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: NovoPen™ 4
  • Device: NovoPen® 3
 Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
208 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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 Start Date :
Aug 1, 2003
Actual Primary Completion Date :
Feb 1, 2004
Actual Study Completion Date :
Feb 1, 2004

Outcome Measures

Primary Outcome Measures

  1. Evaluation of overall pen preference [after 12 weeks of treatment]

Secondary Outcome Measures

  1. HbA1c []

  2. Adverse device effects []

  3. Adverse events []

Eligibility Criteria

Criteria

Ages Eligible for Study:
9 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Novo Nordisk Investigational Site Wien Austria 1090
2 Novo Nordisk Investigational Site Wien Austria A 1090
3 Novo Nordisk Investigational Site Köln Germany 50858
4 Novo Nordisk Investigational Site Leverkusen Germany 51373
5 Novo Nordisk Investigational Site München Germany 81377
6 Novo Nordisk Investigational Site Speyer Germany 67346
7 Novo Nordisk Investigational Site St. Ingbert Germany 66386
8 Novo Nordisk Investigational Site Völklingen Germany 66333
9 Novo Nordisk Investigational Site Catania Italy 95122
10 Novo Nordisk Investigational Site Palermo Italy 90127
11 Novo Nordisk Investigational Site Parma Italy 43100
12 Novo Nordisk Investigational Site Roma Italy 00165
13 Novo Nordisk Investigational Site Torino Italy 10144
14 Novo Nordisk Investigational Site Almere Netherlands 1315 RA
15 Novo Nordisk Investigational Site Amsterdam Netherlands 1081 HV
16 Novo Nordisk Investigational Site Den Haag Netherlands 2512 VA
17 Novo Nordisk Investigational Site Heerlen Netherlands 6419 PC
18 Novo Nordisk Investigational Site Rotterdam Netherlands 3015 GD
19 Novo Nordisk Investigational Site Veldhoven Netherlands 5504 DB
20 Novo Nordisk Investigational Site Belfast United Kingdom BT12 6BE
21 Novo Nordisk Investigational Site Belfast United Kingdom BT37 9RH
22 Novo Nordisk Investigational Site Leeds United Kingdom LS9 7TF
23 Novo Nordisk Investigational Site Sidcup United Kingdom DA14 6LT

Sponsors and Collaborators

  • Novo Nordisk A/S

Investigators

  • Study Director: Global Clinical Registry (GCR, 1452), Novo Nordisk A/S

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00569998
Other Study ID Numbers:
  • MS236-1544
First Posted:
Dec 10, 2007
Last Update Posted:
Jan 19, 2017
Last Verified:
Jan 1, 2017
Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Diabetes Mellitus, Type 1

Study Results

No Results Posted as of Jan 19, 2017