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

NCT ID: NCT00849316

Last Updated: 2023-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2009-02-28

Study Completion Date

2009-11-30

Brief Summary

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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

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Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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A

insulin aspart

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ankit Pathak, MD

Role: STUDY_DIRECTOR

Novo Nordisk India Ltd

Ashok Moharana, MD

Role: STUDY_DIRECTOR

Novo Nordisk India Private Ltd.

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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ANA-3702

Identifier Type: -

Identifier Source: org_study_id

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