Special Survey for Type 1 or Type 2 Diabetic Patients

This study is conducted in Japan. The aim of this study is to evaluate the incidence of severe hypoglycaemia episodes under normal clinical practice for patients with type 1 or type 2 diabetes.

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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 diabetes requiring insulin therapy

Exclusion criteria

Patients who had not been treated more than 3 months at the same investigational site
Patients who had treatment history of NovoRapid® (insulin aspart)

Treatment and study plan

insulin aspart

Drug

Adminstered subcutaneously (s.c., under the skin). Prescribed by physician as a results of normal clinical practice

Primary outcomes

HbA1c (glycosylated haemoglobin)

Secondary outcomes

Incidence of servere hypoglycaemia
Total dose of insulin (aspart/human insulin) infused subcutaneously
Physical examination
Adverse events

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Important dates

Study start: 2002
Primary completion: 2009
Study completion: 2009
First posted: Dec 7, 2011
Registry last updated: Mar 4, 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.

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

Completed