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

• Sponsor: Novo Nordisk A/S (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01454024
• Collaborator: (none)
• Enrollment: 1,031
• Location: 1
• Duration (Months): 11
• Patients Per Site Per Month: 93.7

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Delivery Systems	Device: FlexPen®; Device: NovoPen® 3

Study Design

• Study Type: Observational
• Actual Enrollment: 1031 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: A Study Evaluating the Safety of NovoPen®3 and FlexPen® in Subjects With Type 1 and Type 2 Diabetes. A 24-week, Prospective, Multi-centre, Open-labelled, Non-interventional Study
• Study Start Date: Nov 1, 2011
• Actual Primary Completion Date: Oct 1, 2012
• Actual Study Completion Date: Oct 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Total study population	Device: FlexPen®; Prescribed insulin treatment delivered by FlexPen® as part of routine clinical practice; Device: NovoPen® 3; Prescribed insulin treatment delivered by NovoPen® 3 as part of routine clinical practice

Outcome Measures

Primary Outcome Measures

1. Number of adverse events and technical complaints [Week 0-24]

Secondary Outcome Measures

1. Number of adverse drug reactions (ADR) including hypoglycaemic events [Week 0-12, week 24]

2. Number of serious adverse drug reactions including major hypoglycaemic events [Week 0-12, week 24]

3. HbA1c (haemoglobin A1c) [Week 0, week 12 and week 24]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Karachi		Pakistan

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:

• Clinical Trials at Novo Nordisk

Publications

None provided.

• Responsible Party: Novo Nordisk A/S
• ClinicalTrials.gov Identifier: NCT01454024
• Other Study ID Numbers: NOPEN3-3882; U1111-1116-2517
• First Posted: Oct 18, 2011
• Last Update Posted: Jun 12, 2015
• Last Verified: Jun 1, 2015

• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1

Study Results

No Results Posted as of Jun 12, 2015