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Special Survey for Patients With Type 1 or Type 2 Diabetes

Special Survey for Type 1 or Type 2 Diabetic Patients

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01538589
Enrollment
1582
Registered
2012-02-24
Start date
2003-12-31
Completion date
2009-10-31
Last updated
2016-03-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2

Brief summary

This study is conducted in Japan. The aim of this study is to evaluate the incidence of severe hypoglycaemia under normal clinical practice.

Interventions

DRUGinsulin aspart

Prescribed by the physicians as a result of normal clinical practice

Sponsors

Novo Nordisk A/S
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* Patients with no treatment history of insulin aspart (NovoRapid®)

Design outcomes

Primary

MeasureTime frame
Occurrence of severe hypoglycaemic symptomsYear 1
Antibody titre findingsYear 1
Adverse eventsYear 1

Secondary

MeasureTime frame
Response rate assessed by the investigator: Ability or failure to achieve expected glycaemic controlYear 1
HbA1c (glycosylated haemoglobin)Year 1
Total dose of insulin infused subcutaneouslyYear 1

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026