An Observational Study of Type 2 Diabetes in Patients Starting on NovoMix® 30 Treatment

An Observational, Prospective Safety Study in Subjects With Type 2 Diabetes Mellitus Starting NovoMix® 30 (Biphasic Insulin Aspart) Treatment

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00696995

Acronym

Start

Enrollment

509

Registered

2008-06-13

Start date

2007-01-31

Completion date

2008-09-30

Last updated

2017-01-09

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 observational study is to evaluate the incidence of serious adverse drug reactions when initiating or switching to insulin therapy with NovoMix® 30 in subjects with type 2 diabetes under normal clinical practice conditions

Interventions

DRUGbiphasic insulin aspart 30

Start dose and frequency as well as dose alterations to be determined by the physician according to normal clinical evaluation

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

No minimum to 99 Years

Healthy volunteers

Inclusion criteria

* Patients with Type 2 diabetes * Insulin-naive or previously treated by basal only insulin therapy

Exclusion criteria

* Patients who are unlikely to comply with the protocol * Pregnancy or breastfeeding or intention of becoming pregnant

Design outcomes

Primary

Measure	Time frame
The number of serious adverse drug reactions, including major hypoglycaemic events	at 26 weeks

Secondary

Measure	Time frame
The number of all hypoglycaemic events	at 26 weeks
HbA1c	at 12 weeks and 26 weeks
Fasting plasma glucose at visits	at 12 weeks and 26 weeks

Countries

Finland

Outcome results

None listed

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