Observational Study to Evaluate the Safety and Efficacy of NovoMix® 70 in Type 2 Diabetes

Observational Study on Safety and Efficacy in Subjects Using NovoMix® 70 (Biphasic Insulin Aspart) for Treatment of Type 2 Diabetes Mellitus

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00704223

Acronym

INTENSIV

Enrollment

619

Registered

2008-06-24

Start date

2008-05-31

Completion date

2008-11-30

Last updated

2014-06-24

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 study is conducted in Europe. The aim of this observational study is to evaluate the incidence of adverse events while using NovoMix® 70 under normal clinical practice conditions in Austria.

Interventions

DRUGbiphasic insulin aspart

Start dose and frequency to prescribed by the physician as a result of a normal clinical evaluation

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Type 2 diabetes * HbA1c over 7% * No contraindication with NovoMix® 70

Exclusion criteria

* Type 1 diabetes * Subjects participating in a clinical trial or another observational study * Subjects under previous basis-bolus insulin therapy * Women who are pregnant, breast feeding and women of child bearing capacity who are not using any reliable contraceptive method

Design outcomes

Primary

Measure	Time frame
number of major and minor hypoglycaemic events and adverse events	3 months

Secondary

Measure	Time frame
HbA1c	3 months
PPBG	3 months
FBG	3 months

Countries

Austria

Outcome results

None listed

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