Skip to main content
OpenTrials
Completed

NCT Number: NCT01538589

Special Survey for Patients With Type 1 or Type 2 Diabetes

This study is conducted in Japan. The aim of this study is to evaluate the incidence of severe hypoglycaemia under normal clinical practice.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Tokyo, 1000005, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with no treatment history of insulin aspart (NovoRapid®)

Treatment and study plan

insulin aspart

Drug

Prescribed by the physicians as a result of normal clinical practice

Primary outcomes

  1. Occurrence of severe hypoglycaemic symptoms

    Time frame: Year 1

  2. Occurrence of severe hypoglycaemic symptoms

    Time frame: Year 2 for patients who had an antibody titre test performed

  3. Antibody titre findings

    Time frame: Year 1

  4. Antibody titre findings

    Time frame: Year 2 for patients who had an antibody titre test performed

  5. Adverse events

    Time frame: Year 1

  6. Adverse events

    Time frame: Year 2 for patients who had an antibody titre test performed

Secondary outcomes

  1. Response rate assessed by the investigator: Ability or failure to achieve expected glycaemic control

    Time frame: Year 1

  2. Response rate assessed by the investigator: Ability or failure to achieve expected glycaemic control

    Time frame: Year 2 for patients who had an antibody titre test performed

  3. HbA1c (glycosylated haemoglobin)

    Time frame: Year 1

  4. HbA1c (glycosylated haemoglobin)

    Time frame: Year 2 for patients who had an antibody titre test performed

  5. Total dose of insulin infused subcutaneously

    Time frame: Year 1

  6. Total dose of insulin infused subcutaneously

    Time frame: Year 2 for patients who had an antibody titre test performed

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

Special Survey for Type 1 or Type 2 Diabetic Patients

Important dates

Study start
2003
Primary completion
2009
Study completion
2009
First posted
Feb 24, 2012
Registry last updated
Mar 7, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.