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Observational Study With InnoLet® in Daily Clinical Practice

A Prospective, Open, Uncontrolled, Observational Study With Innolet in Daily Clinical Situations According to the Product Labelling, Without Any Study Specific Investigations

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01492959
Enrollment
1030
Registered
2011-12-15
Start date
2004-03-23
Completion date
2005-03-23
Last updated
2017-02-28

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 Asia. The aim of this study is to review the efficacy and safety of insulin treatment with InnoLet® in daily clinical practice.

Interventions

Insulin human delivered with the InnoLet® device was prescribed according to product labelling to subjects in need of insulin treatment

Sponsors

Novo Nordisk A/S
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* Diabetes mellitus (Type 1 or type 2) * Need insulin treatment

Design outcomes

Primary

MeasureTime frame
Change in HbA1c (glycosylated haemoglobin)

Secondary

MeasureTime frame
Adverse events: Serious and non-serious

Countries

South Korea

Outcome results

None listed

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