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

This study has been withdrawn prior to enrollment.
(Due to company decision to focus resources on the finalisation of three ongoing studies in the region)
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00849316
First received: February 20, 2009
Last updated: January 18, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention
Diabetes
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Chronic Kidney Disease
Drug: insulin aspart

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Incidence of major hypoglycaemic episodes [ Time Frame: during 26 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Number of serious adverse events [ Time Frame: during 26 weeks ] [ Designated as safety issue: Yes ]
  • Number of serious adverse drug reactions [ Time Frame: during 26 weeks ] [ Designated as safety issue: Yes ]
  • Number of all daytime and nocturnal major hypoglycaemic events [ Time Frame: during 26 weeks ] [ Designated as safety issue: No ]
  • Number of major hypoglycaemic events related to omission of a meal after injection [ Time Frame: during 26 weeks ] [ Designated as safety issue: Yes ]
  • Number of all minor (daytime and nocturnal) hypoglycaemic events [ Time Frame: during 4 weeks proceeding each study visits during Insulin Aspart (NovoRapidTM) therapy ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: February 2009
Estimated Study Completion Date: November 2009
Estimated Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

  Eligibility

Genders Eligible for Study:   Both
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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00849316

Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Ankit Pathak, MD Novo Nordisk India Ltd
Study Director: Ashok Moharana, MD Novo Nordisk India Private Ltd.
  More Information

Additional Information:
No publications provided

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00849316     History of Changes
Other Study ID Numbers: ANA-3702
Study First Received: February 20, 2009
Last Updated: January 18, 2013
Health Authority: India: Ministry of Health

Additional relevant MeSH terms:
Kidney Diseases
Diabetes Mellitus
Diabetes Mellitus, Type 2
Renal Insufficiency, Chronic
Diabetes Mellitus, Type 1
Urologic Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Renal Insufficiency
Autoimmune Diseases
Immune System Diseases
Insulin
Insulin Aspart
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 22, 2014