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

Withdrawn

• Conditions: Diabetes; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Chronic Kidney Disease
• Interventions: Drug: insulin aspart

• Registration Number: NCT00849316
• Lead Sponsor: Novo Nordisk A/S

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-02
• Study First Submitted: 2009-02-20
• Study First Submitted QC: 2009-02-20
• Study First Posted: 2009-02-23
• Primary Completion: 2009-11
• Study Completion: 2009-11
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-31
• Last Update Posted: 2023-11-02

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
A	insulin aspart	-

Primary Outcome Measures

Name	Time	Method
Incidence of major hypoglycaemic episodes	during 26 weeks

Secondary Outcome Measures

Name	Time	Method
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