Diabetes, Diabetes Mellitus, Type 2
Conditions
Brief summary
This trial is conducted in Europe. The aim of this observational study is to evaluate the incidence of major hypoglycaemic episodes in patients with type 2 diabetes treated with NovoRapid® or Soluble Human Insulin under normal clinical practice conditions.
Interventions
Observational study; use of the products as in the normal clinical practice conditions
DRUGbiphasic insulin aspart
Observational study; use of the products as in the normal clinical practice conditions
Sponsors
Novo Nordisk A/S
Study design
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Patients with type 2 diabetes * Treatment with Insulin Aspart (NovoRapid®) or Soluble Human Insulin for minimum 3 months and maximum 3 years
Exclusion criteria
* Patients with an end-stage renal failure * Patients with a serious liver disease * Patients with concomitant malignant disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of major hypoglycaemic events reported as serious adverse drug reactions | after 26 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Number of serious adverse event | during 26 weeks |
| Number of all major (daytime and nocturnal) hypoglycaemic events | during 26 weeks |
| Number of major hypoglycaemic events related to omission of a meal after injection | during 26 weeks |
| Number of major hypoglycaemic events related to physical exercise of at least 30 min duration | during 26 weeks |
| Number of serious and non serious drug reactions | during 26 weeks |
| Weight and waist circumference change | during 26 weeks |
| Number of hypoglycaemia events in the two different treatment groups based on the HbA1c level | after 26 weeks |
| Quality of Life (QoL) | after 26 weeks |
| Number of all minor (daytime and nocturnal) hypoglycaemic events during 4 weeks preceding each study visit | after 26 weeks |
Countries
Italy
Outcome results
None listed