Diabetes, Diabetes Mellitus, Type 2
Conditions
Brief summary
The study is conducted in Europe. The aim of this observational study is to evaluate the blood glucose control in patients using a modern insulin: NovoRapid®, NovoMix® 30 or Levemir® for the treatment type 2 diabetes. Full acronym for this study: COMMIT - CLEAN SWITCH
Interventions
DRUGinsulin detemir
Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation
DRUGinsulin aspart
Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation
DRUGbiphasic insulin aspart 30
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
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with type 2 diabetes * Patients treated with human soluble insulin, NPH insulin or premixed human insulin * Patients willing to sign informed consent * Selection of study participants at the discretion of the physician
Exclusion criteria
* Subjects currently being treated with insulin aspart, insulin detemir or biphasic insulin aspart 30 * Subjects who were previously enrolled in this study * Subjects with a hypersensitivity to insulin aspart, insulin detemir or biphasic insulin aspart 30 or to any of the excipients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Metabolic control measured as HbA1c | for the duration of the study |
Secondary
| Measure | Time frame |
|---|---|
| Change in FPG (glucose variability) | after 12 weeks and 24 weeks |
| Change in PPG (postprandial control) | after 12 weeks and 24 weeks |
| Change in insulin dose and number of injections | after 12 weeks and 24 weeks |
| Percentage of subjects achieving HbA1c below 7.0% and below or equal 6.5% | after 12 weeks and 24 weeks |
| Change in body weight | after 12 weeks and 24 weeks |
| Change in number of hypoglycaemic events during 4 weeks proceeding routine visits | after 12 weeks and 24 weeks |
| Number of adverse drug reactions (ADR) | after 12 weeks and 24 weeks |
| Change in oral antidiabetic drug therapy | after 12 weeks and 24 weeks |
Countries
Slovakia
Outcome results
None listed