Observational Study of Safety and Effectiveness of NovoMix® 30 for the Treatment of Diabetes

Novo Nordisk A/S57,610 enrolled

Overview

This study is conducted in Asia, Europe, Japan and North America. The aim of this observational study is to evaluate the safety and effectiveness while using NovoMix® 30 during 26 weeks under normal clinical practice, in the countries participating in the study. The primary outcome is the incidence of major hypoglycaemic events reported as serious adverse drugs reaction conditions on hypoglycaemic events.

Study Type

OBSERVATIONAL

Enrollment

57,610

Conditions

Diabetes Diabetes Mellitus, Type 2

Interventions

biphasic insulin aspartDRUG

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

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: * Age according to approved label and physician discretion * Type 2 diabetes including newly-diagnosed subjects who have never received insulin or an insulin analogue before Exclusion Criteria: * Subjects who previously enrolled in this study * Subjects who are unlikely to comply with protocol requirements * Hypersensitivity to biphasic insulin aspart or to any of the excipients * Women who are pregnant, breast feeding or have the intention of becoming pregnant within next 12 months

Locations (11)

Novo Nordisk Investigational Site

Mississauga, Canada

Novo Nordisk Investigational Site

Beijing, Beijing Municipality, China

Novo Nordisk Investigational Site

Vouliagment, Greece

Outcomes

Primary Outcomes

Incidence of major hypoglycaemic events reported as serious adverse drug reactions

Time frame: during treatment

Data from ClinicalTrials.gov

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