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Long Term Safety and Efficacy of Biphasic Insulin Aspart 30 in Subjects With Type 2 Diabetes

A Multi-centre, Non-comparative, Open-labelled, Extension Trial to Assess the Long Term Safety and Efficacy of Biphasic Insulin Aspart 30 in Subjects With Type 2 Diabetes (Extension to BIAsp-1237)

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01527539
Enrollment
25
Registered
2012-02-07
Start date
2001-11-23
Completion date
2004-10-12
Last updated
2017-02-24

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

Conditions

Diabetes, Diabetes Mellitus, Type 2

Brief summary

This trial is conducted in North America. The aim of this trial is asses the long term safety and efficacy of biphasic insulin aspart 30 in Canadian subjects with type 2 diabetes who had participated in the BIAsp-1237 trial.

Interventions

DRUGbiphasic insulin aspart 30

Dose individually adjusted. Injected twice daily immediately before breakfast and dinner. Administrated subcutaneously (s.c., under the skin)

Sponsors

Novo Nordisk A/S
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Completed the BIAsp-1237 trial

Design outcomes

Primary

MeasureTime frame
HbA1c

Secondary

MeasureTime frame
Occurrence of adverse events
Occurence of hypoglycaemic episodes

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 9, 2026