Observational Study of Safety of NovoMix® 30 Treatment for Type 2 Diabetes

NovoMix® Start - A Multicentre, Open Label, Non-randomised, Non-interventional, Observational Safety Study in Subjects With Type 2 Diabetes Mellitus Starting NovoMix 30® Treatment

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01486875

Acronym

Start

Enrollment

1155

Registered

2011-12-07

Start date

2006-01-31

Completion date

2008-01-31

Last updated

2017-01-06

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 Europe. The aim of this trial is to evaluate the incidence of serious adverse drug reactions when initiating insulin therapy with NovoMix® 30 in subjects with type 2 diabetes mellitus under normal clinical practice conditions in Sweden.

Interventions

DRUGbiphasic insulin aspart 30

Dose individually adjusted, and administered subcutaneously (under the skin) once or twice daily

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 68 Years

Healthy volunteers

Inclusion criteria

* Subjects with type 2 diabetes

Design outcomes

Primary

Measure	Time frame
Incidence of serious adverse drug reactions (SADRs)	Week 26
Incidence of major hypoglycaemic events	Week 26

Secondary

Measure	Time frame
Number of all hypoglycaemic events	In the 4 weeks prior to week 12 and week 26, respectively
HbA1c (glycosylated haemoglobin A1c)	Week 26
Fasting Plasma Glucose (FPG)	Week 26

Countries

Sweden

Outcome results

None listed

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