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

• Sponsor: Novo Nordisk A/S (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00675220
• Collaborator: (none)
• Enrollment: 373
• Location: 1
• Duration (Months): 6
• Patients Per Site Per Month: 62

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Delivery Systems	Drug: insulin aspart

Study Design

• Study Type: Observational
• Actual Enrollment: 373 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• 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
• Study Start Date: Jun 1, 2007
• Actual Primary Completion Date: Dec 1, 2007
• Actual Study Completion Date: Dec 1, 2007

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Safety profile of Insulin Aspart among Filipino patients [1-month follow-up for outpatients; 1 month or upon discharge for inpatients whichever comes first]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novo Nordisk Investigational Site	Manilla		Philippines	1605

Sponsors and Collaborators

• Novo Nordisk A/S

Investigators

• Study Director: Global Clinical Registry (GCR, 1452), Novo Nordisk A/S

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Clinical Trials at Novo Nordisk

Publications

None provided.

• Responsible Party: Novo Nordisk A/S
• ClinicalTrials.gov Identifier: NCT00675220
• Other Study ID Numbers: ANA-1884
• First Posted: May 9, 2008
• Last Update Posted: Oct 28, 2016
• Last Verified: Oct 1, 2016

• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1; Insulin Aspart

Study Results

No Results Posted as of Oct 28, 2016