Diabetes, Diabetes Mellitus, Type 2
Conditions
Brief summary
This study is conducted in Europe. An observational study evaluating the blood glucose control in patients using a modern insulin: NovoRapid®, NovoMix® 30 or Levemir® for treatment of Type 2 diabetes mellitus in Czech Republic.
Interventions
DRUGinsulin aspart
Intervention at the discretion of the physician
DRUGinsulin detemir
Intervention at the discretion of the physician
DRUGbiphasic insulin aspart 30
Intervention at the discretion of the physician
Sponsors
Novo Nordisk A/S
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Type 2 diabetes * Current treatment with human soluble insulin, insulin NPH or premixed human insulin * The selection of the subjects will be at the discretion of the individual physician
Exclusion criteria
* Current treatment with insulin aspart, insulin detemir or biphasic insulin aspart 30 * Previous enrolment in this study * Hypersensitivity to insulin aspart, insulin detemir or biphasic insulin aspart 30 or to any of the excipients. * Women who are pregnant, breast feeding or have the intention of becoming pregnant within next 6 months and considered to be treated by biphasic insulin aspart 30 or insulin detemir
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HbA1c after switch from human insulin to modern insulin treatment | After 24 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Postprandial glycaemic control as measured by PPG | After 12 and 24 weeks |
| Glucose variability as measured by FPG | After 12 and 24 weeks |
| Insulin dose and number of injections | After 12 and 24 weeks |
| Percentage of subjects to reach HbA1c below 7.0% and = 6.5% at approximately 12 weeks and 24 weeks of treatment | After 12 and 24 weeks |
| Number of hypoglycaemic events | During treatment |
| Number of adverse drug reactions (ADR) | After 12 and 24 weeks |
| Body weight | After 12 and 24 weeks |
Countries
Czechia
Outcome results
None listed