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

January 18, 2017 updated by: Novo Nordisk A/S

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

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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

208

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Wien, Austria, 1090
        • Novo Nordisk INvestigational Site
      • Wien, Austria, A 1090
        • Novo Nordisk INvestigational Site
      • Köln, Germany, 50858
        • Novo Nordisk INvestigational Site
      • Leverkusen, Germany, 51373
        • Novo Nordisk INvestigational Site
      • München, Germany, 81377
        • Novo Nordisk INvestigational Site
      • Speyer, Germany, 67346
        • Novo Nordisk INvestigational Site
      • St. Ingbert, Germany, 66386
        • Novo Nordisk INvestigational Site
      • Völklingen, Germany, 66333
        • Novo Nordisk INvestigational Site
      • Catania, Italy, 95122
        • Novo Nordisk INvestigational Site
      • Palermo, Italy, 90127
        • Novo Nordisk INvestigational Site
      • Parma, Italy, 43100
        • Novo Nordisk INvestigational Site
      • Roma, Italy, 00165
        • Novo Nordisk INvestigational Site
      • Torino, Italy, 10144
        • Novo Nordisk INvestigational Site
      • Almere, Netherlands, 1315 RA
        • Novo Nordisk INvestigational Site
      • Amsterdam, Netherlands, 1081 HV
        • Novo Nordisk INvestigational Site
      • Den Haag, Netherlands, 2512 VA
        • Novo Nordisk INvestigational Site
      • Heerlen, Netherlands, 6419 PC
        • Novo Nordisk INvestigational Site
      • Rotterdam, Netherlands, 3015 GD
        • Novo Nordisk INvestigational Site
      • Veldhoven, Netherlands, 5504 DB
        • Novo Nordisk INvestigational Site
      • Belfast, United Kingdom, BT37 9RH
        • Novo Nordisk INvestigational Site
      • Belfast, United Kingdom, BT12 6BE
        • Novo Nordisk INvestigational Site
      • Leeds, United Kingdom, LS9 7TF
        • Novo Nordisk INvestigational Site
      • Sidcup, United Kingdom, DA14 6LT
        • Novo Nordisk INvestigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

9 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evaluation of overall pen preference
Time Frame: after 12 weeks of treatment
after 12 weeks of treatment

Secondary Outcome Measures

Outcome Measure
Adverse events
HbA1c
Adverse device effects

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • 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
  • 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2003

Primary Completion (Actual)

February 1, 2004

Study Completion (Actual)

February 1, 2004

Study Registration Dates

First Submitted

December 4, 2007

First Submitted That Met QC Criteria

December 7, 2007

First Posted (Estimate)

December 10, 2007

Study Record Updates

Last Update Posted (Estimate)

January 19, 2017

Last Update Submitted That Met QC Criteria

January 18, 2017

Last Verified

January 1, 2017

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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