A Multicenter, Open Label, Nonrandomized, Non Interventional, Observational, Safety and Efficacy Study of NovoRapid™(Insulin Aspart) in Patients With Coexisting Diabetes and Kidney Disease in India. The NovoRapid™ Nephropathy Study

Novo Nordisk A/S0 sitesFebruary 2009

ConditionsDiabetes Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Chronic Kidney Disease

Interventionsinsulin aspart

Overview

Phase: Not Applicable
Intervention: insulin aspart
Conditions: Diabetes
Sponsor: Novo Nordisk A/S
Primary Endpoint: Incidence of major hypoglycaemic episodes
Status: Withdrawn
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

February 2009

End Date

November 2009

Last Updated

2 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Novo Nordisk A/S

Responsible Party

Sponsor

Eligibility 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

Arms & Interventions

A

Intervention: insulin aspart

Outcomes

Primary Outcomes

Incidence of major hypoglycaemic episodes

Time Frame: during 26 weeks

Secondary Outcomes

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)