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

Novo Nordisk A/S0 sites619 target enrollmentMay 2008

ConditionsDiabetes Diabetes Mellitus, Type 2

Interventionsbiphasic insulin aspart

Drugsbiphasic insulin aspart

Overview

Phase: Not Applicable
Intervention: biphasic insulin aspart
Conditions: Diabetes
Sponsor: Novo Nordisk A/S
Enrollment: 619
Primary Endpoint: number of major and minor hypoglycaemic events and adverse events
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

May 2008

End Date

November 2008

Last Updated

11 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Novo Nordisk A/S

Responsible Party

Sponsor

Eligibility Criteria

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