NCT00675220CompletedNot Applicable
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
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Novo Nordisk A/S
- Enrollment
- 373
- Locations
- 1
- Primary Endpoint
- Safety profile of Insulin Aspart among Filipino patients
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Sex
- 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)
Arms & Interventions
A
Intervention: insulin aspart (Drug)
Outcomes
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
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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