Observational Safety Study in Subjects With Type 2 Diabetes Mellitus Starting or Switching to Biphasic Insulin Aspart 30 Treatment

Novo Nordisk A/S423 enrolled

Overview

This study is conducted in Europe. The aim of this study is to investigate safety and efficacy in subjects with type 2 diabetes mellitus starting or switching to biphasic insulin aspart 30 (NovoMix® 30) treatment.

Study Type

OBSERVATIONAL

Enrollment

423

Conditions

Diabetes Diabetes Mellitus, Type 2

Interventions

biphasic insulin aspart 30DRUG

Prescribed biphasic insulin aspart 30 as part of routine care. Starting dose, dose titration and injection frequency determined individually by each physician.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: * Subjects with type 2 diabetes

Locations (1)

Novo Nordisk Investigational Site

Copenhagen S, Denmark

Outcomes

Primary Outcomes

Incidence of SADR (serious adverse drug reactions) including major hypoglycaemia

Secondary Outcomes

Change from baseline in HbA1c (glycosylated haemoglobin)

Mean FPG (fasting plasma glucose)

Overall, daytime and nocturnal frequency of hypoglycaemic events

Data from ClinicalTrials.gov

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