Evaluating Safety of NovoPen® 3 and/or FlexPen® Devices in Routine Clinical Practice

NCT ID: NCT01454024

Last Updated: 2015-06-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

1031 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-11-30

Study Completion Date

2012-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study is conducted in Asia. The aim of of this study is to evaluate the safety of NovoPen® 3 and/or FlexPen® devices (if available on the market) measured by the number of adverse events and technical complaints in patients with type 1 and type 2 diabetes in routine clinical practice.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetes Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Delivery Systems

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Total study population

FlexPen®

Intervention Type DEVICE

Prescribed insulin treatment delivered by FlexPen® as part of routine clinical practice

NovoPen® 3

Intervention Type DEVICE

Prescribed insulin treatment delivered by NovoPen® 3 as part of routine clinical practice

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

FlexPen®

Prescribed insulin treatment delivered by FlexPen® as part of routine clinical practice

Intervention Type DEVICE

NovoPen® 3

Prescribed insulin treatment delivered by NovoPen® 3 as part of routine clinical practice

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Any subjects who are previously using Actrapid®, Insulatard®, and Mixtard® 30 with vial / NovoLet® or insulin human with ErgoPen®2 for type 1 and type 2 diabetes treatment, will be eligible for the study after the physician has taken the decision to use study insulin products with the study devices

Exclusion Criteria

* Subjects treated with Actrapid® Penfill®, Insulatard® Penfill®, or Mixtard® 30 Penfill® with NovoPen®3 or Actrapid® FlexPen®, Insulatard® FlexPen®, or Mixtard® 30 FlexPen® for more than 4 weeks before inclusion into this study
* Subjects who were previously enrolled in this study
* Subjects with a hypersensitivity to insulin human or to any of the excipients
* Women who are pregnant, breast feeding or have the intention of becoming pregnant within the next 6 months
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Global Clinical Registry (GCR, 1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Karachi, , Pakistan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Pakistan

Related Links

Access external resources that provide additional context or updates about the study.

http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

U1111-1116-2517

Identifier Type: OTHER

Identifier Source: secondary_id

NOPEN3-3882

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.