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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00849316
Recruitment Status : Withdrawn (Due to company decision to focus resources on the finalisation of three ongoing studies in the region)
First Posted : February 23, 2009
Last Update Posted : January 21, 2013
Information provided by (Responsible Party):
Novo Nordisk A/S

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.

Condition or disease Intervention/treatment
Diabetes Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Chronic Kidney Disease Drug: insulin aspart

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Study Type : Observational
Actual Enrollment : 0 participants
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
Study Start Date : February 2009
Estimated Primary Completion Date : November 2009
Estimated Study Completion Date : November 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

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.

Primary Outcome Measures :
  1. Incidence of major hypoglycaemic episodes [ Time Frame: during 26 weeks ]

Secondary Outcome Measures :
  1. Number of serious adverse events [ Time Frame: during 26 weeks ]
  2. Number of serious adverse drug reactions [ Time Frame: during 26 weeks ]
  3. Number of all daytime and nocturnal major hypoglycaemic events [ Time Frame: during 26 weeks ]
  4. Number of major hypoglycaemic events related to omission of a meal after injection [ Time Frame: during 26 weeks ]
  5. Number of all minor (daytime and nocturnal) hypoglycaemic events [ Time Frame: during 4 weeks proceeding each study visits during Insulin Aspart (NovoRapidTM) therapy ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00849316

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

Additional Information:
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Responsible Party: Novo Nordisk A/S Identifier: NCT00849316    
Other Study ID Numbers: ANA-3702
First Posted: February 23, 2009    Key Record Dates
Last Update Posted: January 21, 2013
Last Verified: January 2013
Additional relevant MeSH terms:
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Insulin Aspart
Kidney Diseases
Renal Insufficiency, Chronic
Diabetes Mellitus
Diabetes Mellitus, Type 2
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Urologic Diseases
Renal Insufficiency
Autoimmune Diseases
Immune System Diseases
Hypoglycemic Agents
Physiological Effects of Drugs