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NCT00675220 Clinical Trial

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

Diabetes Mellitus, Type 2 Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00675220
Other study ID # ANA-1884
Secondary ID
Status Completed
Phase N/A
First received May 6, 2008
Last updated October 26, 2016
Start date June 2007
Est. completion date December 2007

Study information
Verified date October 2016
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority Philippines: Bureau of Food and Drugs
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 373
Est. completion date December 2007
Est. primary completion date December 2007
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility 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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Drug:
• insulin aspart
Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation

Locations
Country Name City State
Philippines Novo Nordisk Investigational Site Manilla

Sponsors (1)
Lead Sponsor Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Philippines, 

Outcome
Type Measure Description Time frame Safety issue
Primary Safety profile of Insulin Aspart among Filipino patients 1-month follow-up for outpatients; 1 month or upon discharge for inpatients whichever comes first No
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