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

Primary Purpose

Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
NovoPen™ 4
NovoPen® 3
Sponsored by
Novo Nordisk A/S
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes

Eligibility Criteria

9 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site

Outcomes

Primary Outcome Measures

Evaluation of overall pen preference

Secondary Outcome Measures

HbA1c
Adverse device effects
Adverse events

Full Information

First Posted
December 4, 2007
Last Updated
January 18, 2017
Sponsor
Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT00569998
Brief Title
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

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
August 2003 (undefined)
Primary Completion Date
February 2004 (Actual)
Study Completion Date
February 2004 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Delivery Systems

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
208 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
NovoPen™ 4
Intervention Type
Device
Intervention Name(s)
NovoPen® 3
Primary Outcome Measure Information:
Title
Evaluation of overall pen preference
Time Frame
after 12 weeks of treatment
Secondary Outcome Measure Information:
Title
HbA1c
Title
Adverse device effects
Title
Adverse events

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Registry (GCR, 1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
Novo Nordisk Investigational Site
City
Wien
ZIP/Postal Code
A 1090
Country
Austria
Facility Name
Novo Nordisk Investigational Site
City
Köln
ZIP/Postal Code
50858
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Leverkusen
ZIP/Postal Code
51373
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
München
ZIP/Postal Code
81377
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Speyer
ZIP/Postal Code
67346
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
St. Ingbert
ZIP/Postal Code
66386
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Völklingen
ZIP/Postal Code
66333
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Catania
ZIP/Postal Code
95122
Country
Italy
Facility Name
Novo Nordisk Investigational Site
City
Palermo
ZIP/Postal Code
90127
Country
Italy
Facility Name
Novo Nordisk Investigational Site
City
Parma
ZIP/Postal Code
43100
Country
Italy
Facility Name
Novo Nordisk Investigational Site
City
Roma
ZIP/Postal Code
00165
Country
Italy
Facility Name
Novo Nordisk Investigational Site
City
Torino
ZIP/Postal Code
10144
Country
Italy
Facility Name
Novo Nordisk Investigational Site
City
Almere
ZIP/Postal Code
1315 RA
Country
Netherlands
Facility Name
Novo Nordisk Investigational Site
City
Amsterdam
ZIP/Postal Code
1081 HV
Country
Netherlands
Facility Name
Novo Nordisk Investigational Site
City
Den Haag
ZIP/Postal Code
2512 VA
Country
Netherlands
Facility Name
Novo Nordisk Investigational Site
City
Heerlen
ZIP/Postal Code
6419 PC
Country
Netherlands
Facility Name
Novo Nordisk Investigational Site
City
Rotterdam
ZIP/Postal Code
3015 GD
Country
Netherlands
Facility Name
Novo Nordisk Investigational Site
City
Veldhoven
ZIP/Postal Code
5504 DB
Country
Netherlands
Facility Name
Novo Nordisk Investigational Site
City
Belfast
ZIP/Postal Code
BT12 6BE
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Belfast
ZIP/Postal Code
BT37 9RH
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Leeds
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Sidcup
ZIP/Postal Code
DA14 6LT
Country
United Kingdom

12. IPD Sharing Statement

Citations:
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 & Therapeutics 2005; 7 (2): 390
Results Reference
result
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
Results Reference
result
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk

Learn more about this trial

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

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