Chronic Kidney Disease, Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
Conditions
Brief summary
This study is conducted in Asia. The aim of this observational study is to investigate the clinical safety profile and effectiveness while using SC NovoRapid™ (insulin aspart) in patients with coexisting diabetes and kidney disease under normal clinical practice conditions in India.
Interventions
DRUGinsulin aspart
Safety and effectiveness data collection in connection with the use of the drug NovoRapid™ in patients with coexisting diabetes and chronic kidney disease in daily clinical practice.
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
* Any subject with coexisting kidney disease and type 1 or type 2 diabetes is eligible for the study, including: newly-diagnosed subjects, insulin naïve and subjects who have received insulin or an insulin analogue before * Subjects with kidney disease (stage I-IV) including transplant patients will be eligible for the study, if initiated with NovoRapid™
Exclusion criteria
* Subjects who are unlikely to comply with protocol requirements, e.g., uncooperative attitude, inability to return for the final visit * Subjects with stage V of chronic kidney disease * Subjects who previously enrolled in this study * Known or suspected allergy to trial product(s) or related products
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of major hypoglycaemic episodes | during 26 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Number of serious adverse events | during 26 weeks |
| Number of serious adverse drug reactions | during 26 weeks |
| Number of all daytime and nocturnal major hypoglycaemic events | during 26 weeks |
| Number of major hypoglycaemic events related to omission of a meal after injection | during 26 weeks |
| Number of all minor (daytime and nocturnal) hypoglycaemic events | during 4 weeks proceeding each study visits during Insulin Aspart (NovoRapidTM) therapy |
Outcome results
None listed