Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
Conditions
Brief summary
This trial is conducted in Europe. The aim of this observational study is to evaluate the glycaemic control in patients with type 1 or 2 diabetes using NovoMix® 30 or Levemir® under normal clinical practice conditions.
Interventions
DRUGbiphasic insulin aspart 30
Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation
DRUGinsulin detemir
Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation
Sponsors
Novo Nordisk A/S
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
6 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with Type 1 or Type 2 diabetes, including newly diagnosed * Age: Levemir® above 6 years * Age: Novomix® above 18 years
Exclusion criteria
* Current treatment with NovoMix® 30 or Levemir®
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Glycaemic control as measured by HbA1c | After 24 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of subjects to reach HbA1c below 7.0% and =6.5% | After 24 weeks |
| Percentage of subjects on once vs twice daily injections of Levemir® or NovoMix® 30 | After 24 weeks |
| The effect on glycamic control as measured by FPG | After 24 weeks |
| The effect on glycamic control as measured by PG profile | After 24 weeks |
| Change in body weight | After 24 weeks |
Countries
Bosnia and Herzegovina
Outcome results
None listed