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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00675220

Enrollment

373

Registered

2008-05-09

Start date

2007-06-30

Completion date

2007-12-31

Last updated

2016-10-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Brief summary

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.

Interventions

DRUGinsulin aspart

Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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)

Design outcomes

Primary

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

Countries

Philippines

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026