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

NCT00849316 | Withdrawn

• 1 other identifier: ANA-3702
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Incidence of major hypoglycaemic episodes

  during 26 weeks

Secondary Outcomes (5)

• 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

Study Arms (1)

A

Drug: insulin aspart

Interventions

insulin aspart 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.

A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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™"

You may not qualify if:

• 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

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Related Links

• Clinical Trials at Novo Nordisk

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Renal Insufficiency, Chronic

Interventions

Insulin Aspart

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Insulin, Short-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Ankit Pathak, MD

  Novo Nordisk India Ltd

  STUDY DIRECTOR

• Ashok Moharana, MD

  Novo Nordisk India Private Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2009
• First Posted: February 23, 2009
• Study Start: February 1, 2009
• Primary Completion: November 1, 2009
• Study Completion: November 1, 2009
• Last Updated: November 2, 2023

Record last verified: 2023-10