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

Sponsor

Novo Nordisk A/S (Industry)

Overall Status

Withdrawn

CT.gov ID

NCT00849316

Collaborator

(none)

Enrollment

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Chronic Kidney Disease	Drug: insulin aspart

Study Design

Study Type:

Observational

Actual Enrollment :

0 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Feb 1, 2009

Anticipated Primary Completion Date :

Nov 1, 2009

Anticipated Study Completion Date :

Nov 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
A	Drug: insulin 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.

Outcome Measures

Primary Outcome Measures

Incidence of major hypoglycaemic episodes [during 26 weeks]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts 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