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NCT00849316 Clinical Trial

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

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT00849316
Other study ID # ANA-3702
Secondary ID
Status Withdrawn
Phase
First received
Last updated
Start date February 2009
Est. completion date November 2009

Study information
Verified date October 2023
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date November 2009
Est. primary completion date November 2009
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Novo Nordisk A/S

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of major hypoglycaemic episodes during 26 weeks
Secondary Number of serious adverse events during 26 weeks
Secondary Number of serious adverse drug reactions during 26 weeks
Secondary Number of all daytime and nocturnal major hypoglycaemic events during 26 weeks
Secondary Number of major hypoglycaemic events related to omission of a meal after injection during 26 weeks
Secondary Number of all minor (daytime and nocturnal) hypoglycaemic events during 4 weeks proceeding each study visits during Insulin Aspart (NovoRapidTM) therapy
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