Special Survey for Type 1 or Type 2 Diabetic Patients

Completed

• Conditions: Diabetes; Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1
• Interventions: Drug: insulin aspart

• Registration Number: NCT01487408
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-04
• Primary Completion: 2009-10
• Study Completion: 2009-10
• Study First Submitted: 2011-11-29
• Study First Submitted QC: 2011-12-05
• Study First Posted: 2011-12-07
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-03
• Last Update Posted: 2016-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1463

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Insulin Aspart	insulin aspart	-

Primary Outcome Measures

Name	Time	Method
HbA1c (glycosylated haemoglobin)

Secondary Outcome Measures

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