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Safety of Treatment Initiation With Biphasic Insulin Aspart 30 in Hospitalised Patients With Type 2 Diabetes

Multicenter, Open Label, Non-randomized, Non-interventional Observational Study of Safety of Treatment Initiation With a Biphasic Insulin Aspart (NovoMix® 30) in Hospitalized Patients With Type 2 Diabetes Mellitus

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01565733
Enrollment
2223
Registered
2012-03-29
Start date
2007-01-31
Completion date
2007-07-31
Last updated
2016-10-31

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 study is conducted in Europe. The aim of this study is to evaluate the safety and efficacy of biphasic insulin aspart (NovoMix® 30) in hospitalised patients with type 2 diabetes with the aim of intensifying their treatment.

Interventions

DRUGbiphasic insulin aspart 30

Biphasic insulin aspart 30 prescribed solely on the basis of clinical judgement. Initial dose, frequency of injections and further dosage amendments at the discretion of the treating physician.

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 type 2 diabetes * Treated with oral anti-diabetics and/or human insulin

Exclusion criteria

* Persons previously included in the trial * Hypersensitive to biphasic insulin aspart or any of the excipients * Pregnant or lactating women, or those who plan to get pregnant within the next 12 months

Design outcomes

Primary

MeasureTime frame
Frequency of severe hypoglycaemic episodes

Secondary

MeasureTime frame
Number of severe hypoglycaemic episodes
Number of mild hypoglycaemic episodes
Postprandial glucose concentration after breakfast, lunch, and dinner
Average fasting glucose concentration after waking and before main meals
Average plasma glucose level at bedtime and at night

Countries

Poland

Outcome results

None listed

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