Observational Safety Study in Subjects With Type 2 Diabetes Mellitus Starting or Switching to Biphasic Insulin Aspart 30 Treatment
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 Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||A Multicentre, Open Label, Non-randomised, Non-interventional, Observational Safety Study in Subjects With Type 2 Diabetes Mellitus, Starting or Switching to NovoMix® 30 Treatment|
- Incidence of SADR (serious adverse drug reactions) including major hypoglycaemia [ Designated as safety issue: No ]
- Change from baseline in HbA1c (glycosylated haemoglobin) [ Designated as safety issue: No ]
- Mean FPG (fasting plasma glucose) [ Designated as safety issue: No ]
- Overall, daytime and nocturnal frequency of hypoglycaemic events [ Designated as safety issue: No ]
|Study Start Date:||February 2006|
|Study Completion Date:||April 2007|
|Primary Completion Date:||April 2007 (Final data collection date for primary outcome measure)|
|BIAsp 30 users||
Drug: biphasic insulin aspart 30
Prescribed biphasic insulin aspart 30 as part of routine care. Starting dose, dose titration and injection frequency determined individually by each physician.