Diabetes, Diabetes Mellitus, Type 2
Conditions
Brief summary
This study is conducted in Africa, Asia, South America and Europe. The aim of this observational study is to document the experience with the study insulins when used in routine clinical practice. After the physician's decision to start insulin treatment using NovoMix® 30, Levemir® or NovoRapid® (alone or combined), type 2 diabetics will be eligible to be included in this study at the physician's discretion
Interventions
DRUGinsulin aspart
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
DRUGbiphasic insulin aspart
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
Healthy volunteers
No
Inclusion criteria
* After the physician has taken the decision to use NovoMix®30, Levemir® or NovoRapid® (alone or combined), any subject with type 2 diabetes who is not treated with these insulins or who has started on these insulin within the last 4 weeks before inclusion into this study is eligible for the study. * The selection of the subjects will be at the discretion of the individual physician.
Exclusion criteria
* Subjects treated with NovoMix® 30, Levemir® or NovoRapid® (alone or in combination) for more than 4 weeks before inclusion into this study. * Subjects who were previously enrolled in this study. * Subjects with a hypersensitivity to NovoMix® 30, Levemir® or NovoRapid® or to any of the excipients. * Women who are pregnant, breast feeding or have the intention of becoming pregnant within the next 6 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of serious adverse drug reactions and major hypoglycaemic events reported as serious adverse drug reactions | at baseline, 12 weeks and 24 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Evaluate the prescribing patterns and choice of insulin analogues in routine clinical practice | at baseline, 12 weeks and 24 weeks |
| Change in number of hypoglycaemic events | at baseline, 12 weeks and 24 weeks |
| Change in HbA1c | at baseline, 12 weeks and 24 weeks |
| Change in FPG (Fasting Plasma Glucose) | at baseline, 12 weeks and 24 weeks |
| Change in PPG (postprandial glucose) | at baseline, 12 weeks and 24 weeks |
Countries
Algeria, Argentina, Bangladesh, China, Egypt, India, Indonesia, Iran, Jordan, Libya, Malaysia, Mexico, Morocco, Pakistan, Philippines, Russia, Saudi Arabia, Singapore, South Korea, Taiwan, Tunisia, Turkey (Türkiye)
Outcome results
None listed