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

Completed

• Conditions: Diabetes; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Delivery Systems
• Interventions: Drug: insulin aspart

• Registration Number: NCT00675220
• Lead Sponsor: Novo Nordisk A/S

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-06
• Primary Completion: 2007-12
• Study Completion: 2007-12
• Study First Submitted: 2008-05-06
• Study First Submitted QC: 2008-05-07
• Study First Posted: 2008-05-09
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-26
• Last Update Posted: 2016-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 373

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
A	insulin aspart	-

Primary Outcome Measures

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

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇵🇭 Manilla, Philippines