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

Novo Nordisk

Status: Withdrawn

Conditions: Chronic Kidney Disease; Diabetes Mellitus, Type 1; Diabetes; Diabetes Mellitus, Type 2

Treatments: Drug: insulin aspart

Study type: Observational

Funder types: Industry

Identifiers

NCT00849316

ANA-3702

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

0 participants in 1 patient group

A

Treatment:

Drug: insulin aspart