Diabetes Mellitus, Type 2 Clinical Trial
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
Verified date | June 2015 |
Source | Novo Nordisk A/S |
Contact | n/a |
Is FDA regulated | No |
Health authority | Pakistan: Ministry of Health |
Study type | Observational |
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.
Status | Completed |
Enrollment | 1031 |
Est. completion date | October 2012 |
Est. primary completion date | October 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A and older |
Eligibility |
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 |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Novo Nordisk A/S |
Pakistan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of adverse events and technical complaints | Week 0-24 | No | |
Secondary | Number of adverse drug reactions (ADR) including hypoglycaemic events | Week 0-12, week 24 | No | |
Secondary | Number of serious adverse drug reactions including major hypoglycaemic events | Week 0-12, week 24 | No | |
Secondary | HbA1c (haemoglobin A1c) | Week 0, week 12 and week 24 | No |
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