Post Marketing Surveillance Study of Biphasic Insulin Aspart 30

NovoMix® 30 FlexPen, Post Marketing Surveillance Study

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01536613

Enrollment

5346

Registered

2012-02-22

Start date

2004-09-30

Completion date

2007-02-28

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 Asia. The aim of this study is to review the safety and efficacy of biphasic insulin aspart 30 in post-marketing use.

Interventions

DRUGbiphasic insulin aspart 30

The insulin dose and regimen were individualised at the physician's discretion. Insulin was administered by subcutaneous injection using an injection device

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

* Subjects with diabetes who did not have indications that are contraindicated in the product insert

Design outcomes

Primary

Measure	Time frame
Change in body weight	—

Secondary

Measure	Time frame
Change in fasting plasma glucose (FPG)	—
Change in HbA1c (glycosylated haemoglobin)	—
Occurrence of adverse events (non-serious and serious)	—

Countries

South Korea

Outcome results

None listed

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