Diabetes, Diabetes Mellitus, Type 2
Conditions
Brief summary
This study is conducted in Asia. The aim of this observational study is to evaluate the incidence of major hypoglycaemic episodes and other adverse events, and to evaluate efficacy while using insulin under normal clinical practice conditions. The switch from OAD treatment to insulin therapy will be determined by physician.
Interventions
Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation
Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation
DRUGinsulin NPH
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
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
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Type 2 diabetes for at least 12 months and currently receiving oral anti-diabetic (OAD) treatment, whether single or combination, for at least 3 months before this study * Insulin naive * Poor glycaemic control on OADs and decided by the physician to start insulin therapy
Exclusion criteria
* Type 1 diabetes patients * Patients who are unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for the final visit * Patients with a hypersensitivity to insulin or to any of the excipients * Patient groups not approved in the product label
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of major hypoglycaemic episodes | during 26 weeks of insulin therapy |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of patients reaching the target of HbA1c less than 7% | at the end of the study |
| Percentage of patients reaching the target of HbA1c less than 6.5% | at the end of the study |
| Frequency and type of hypoglycaemic episodes | during 26 weeks of insulin therapy |
| Frequency and type of adverse events | during 26 weeks of insulin therapy |
| Frequency and type of adverse drug reactions | during 26 weeks of insulin therapy |
| Percentage of patients reaching the target of HbA1c less than 7.5% | at the end of the study |
| Change in PPG from baseline | during 26 weeks of insulin therapy |
| Change in FPG from baseline | during 26 weeks of insulin therapy |
| Subjects' insulin treatment satisfaction | during 26 weeks of insulin therapy |
| Physicians' satisfaction with insulin therapy | during 26 weeks of insulin therapy |
| Weight change | at the end of the study |
| Change in HbA1c from baseline | during 26 weeks of insulin therapy |
Countries
Indonesia
Outcome results
None listed