Overview

Safety and Efficacy Study of NovoRapid™ in Patients With Coexisting Diabetes and Kidney Disease

Status:
Withdrawn

Trial end date:
2009-11-01

Target enrollment:
0

Participant gender:
All

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.

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Novo Nordisk A/S

Treatments:

Insulin
Insulin Aspart

Criteria

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