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

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.

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Key information

Conditions

Diabetes Autoimmune Diseases Delivery Systems Diabetes Mellitus Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Novo Nordisk Investigational Site

Manila, 1605, Philippines

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

insulin aspart

Drug

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

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

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

Important dates

Study start: 2007
Primary completion: 2007
Study completion: 2007
First posted: May 9, 2008
Registry last updated: Oct 28, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed