Observational Study to Assess the Efficacy and Safety of NovoRapid™ Flexpen™

October 26, 2016 updated by: Novo Nordisk A/S

A Prospective, Open-Labelled, Non-Controlled, Observational Study to Assess the Efficacy and Safety of NovoRapid™ FlexPen™ in the Treatment of Acute Hyperglycemia: A Post-Marketing Surveillance Study

This study is conducted in Asia. The aim of this observational study is to collect efficacy and safety data in diabetic patients with acute hyperglycemia using NovoRapid™ FlexPen™ as per normal clinical practice.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

373

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

  • Philippines
      • Manilla, Philippines, 1605
        • 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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with Diabetes

Description

Inclusion Criteria:

  • Patients with diabetes mellitus (according to product labelling)

Exclusion Criteria:

  • Hypoglycaemia
  • Hypersensitivity to insulin aspart or to any of the excipients (according to product labelling)

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
A
Drug: insulin aspart
Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety profile of Insulin Aspart among Filipino patients
Time Frame: 1-month follow-up for outpatients; 1 month or upon discharge for inpatients whichever comes first
1-month follow-up for outpatients; 1 month or upon discharge for inpatients whichever comes first

Collaborators and Investigators

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

Sponsor

Novo Nordisk A/S

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.

Helpful Links

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

June 1, 2007

Primary Completion (Actual)

December 1, 2007

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

May 6, 2008

First Submitted That Met QC Criteria

May 7, 2008

First Posted (Estimate)

May 9, 2008

Study Record Updates

Last Update Posted (Estimate)

October 28, 2016

Last Update Submitted That Met QC Criteria

October 26, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ANA-1884

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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3
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