CompletedNCT01454024Updated Jun 12, 2015

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

An observational study in Diabetes, Diabetes Mellitus, Type 1 and Diabetes Mellitus, Type 2, sponsored by Novo Nordisk A/S. Completed at 1 site in Pakistan. Per ClinicalTrials.gov, last updated 2015-06-12.

Sponsored by Novo Nordisk A/S · Observational

Study type: Observational
Model: Cohort
Time perspective: Prospective
Enrollment: 1,031
Sex: All

Study 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.

Conditions studied

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

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In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 1,031 is above the median of 233 across 2,220 observational studies indexed under Diabetes Mellitus.

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Lead sponsor

Novo Nordisk A/S is the lead sponsor of 1,370 studies on the registry; 102 are open to participants now.

Of its 198 completed or terminated interventional studies of FDA-regulated products, 94 (47%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible: All
Accepts healthy volunteers: No
Sampling method: Non-probability sample

Study population

The selection of the subjects will be at the discretion of the individual physician based on clinical judgement.

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

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

Study design

Observational model: Cohort
Time perspective: Prospective
Enrollment: 1,031 participants (actual)
Patient registry: No

Groups and cohorts

Total study population
Device: FlexPen® · Device: NovoPen® 3

Interventions

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

What researchers measure

Primary outcomes

Number of adverse events and technical complaints
Time frame: Week 0-24

Secondary outcomes

Number of adverse drug reactions (ADR) including hypoglycaemic events
Time frame: Week 0-12, week 24
Number of serious adverse drug reactions including major hypoglycaemic events
Time frame: Week 0-12, week 24
HbA1c (haemoglobin A1c)
Time frame: Week 0, week 12 and week 24

Study locations

1 site

Karachi, Pakistan

References and documents

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jun 12, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01454024
Lead sponsor: Novo Nordisk A/S
Responsible party: Sponsor
First posted: Oct 18, 2011
Start date: Nov 2011
Primary completion: Oct 2012
Completion: Oct 2012
Last update: Jun 12, 2015

Study contacts

Global Clinical Registry (GCR, 1452)

study director · Novo Nordisk A/S

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2015. You cannot join it, but the record below documents what was studied.

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Discussion

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