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

October 31, 2023 updated by: Novo Nordisk A/S

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Observational

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients from both speciality practice settings who have been deemed appropriate to receive NovoRapid™ as new treatment and as part of routine out-patient care by the prescribing physician.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of major hypoglycaemic episodes
Time Frame: during 26 weeks
during 26 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of major hypoglycaemic events related to omission of a meal after injection
Time Frame: during 26 weeks
during 26 weeks
Number of serious adverse events
Time Frame: during 26 weeks
during 26 weeks
Number of serious adverse drug reactions
Time Frame: during 26 weeks
during 26 weeks
Number of all daytime and nocturnal major hypoglycaemic events
Time Frame: during 26 weeks
during 26 weeks
Number of all minor (daytime and nocturnal) hypoglycaemic events
Time Frame: during 4 weeks proceeding each study visits during Insulin Aspart (NovoRapidTM) therapy
during 4 weeks proceeding each study visits during Insulin Aspart (NovoRapidTM) therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Investigators

  • Study Director: Ankit Pathak, MD, Novo Nordisk India Ltd
  • Study Director: Ashok Moharana, MD, Novo Nordisk India Private Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (Estimated)

November 1, 2009

Study Completion (Estimated)

November 1, 2009

Study Registration Dates

First Submitted

February 20, 2009

First Submitted That Met QC Criteria

February 20, 2009

First Posted (Estimated)

February 23, 2009

Study Record Updates

Last Update Posted (Actual)

November 2, 2023

Last Update Submitted That Met QC Criteria

October 31, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ANA-3702

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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