Diabetes, Diabetes Mellitus, Type 2
Conditions
Brief summary
The study is conducted in Asia. The aim of this observational study is to evaluate the weight change from baseline while using Levemir® in subjects with type 2 diabetes mellitus under normal clinical practice conditions in India.
Interventions
DRUGinsulin detemir
Start dose and frequency of insulin detemir is to be decided by physician. The choice of patient is also at the discretion of Physician
Sponsors
Novo Nordisk A/S
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
6 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Any subject with type 2 diabetes
Exclusion criteria
* Subjects with a hypersensitivity to insulin detemir or any of its excipient * Children below 6 years * Subjects who are pregnant, lactating or planning to become pregnant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Weight change from baseline | after 26 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Number of all adverse events | after 26 weeks |
| Number of all hypoglycemic episodes (24 hr, daytime and nocturnal) | after 26 weeks |
| HbA1c change from baseline | after 26 weeks |
| Number of serious adverse events | after 26 weeks |
| Percentage of patients achieving targets of HbA1c less than 7 % and less than 6.5 % | after 26 weeks |
| Insulin dose and frequency at the end of the study | after 26 weeks |
| FBG (Fasting Blood Glucose) change from baseline | after 26 weeks |
Countries
India
Outcome results
None listed