NCT01538589

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,582

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2003

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2003

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

February 15, 2012

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 24, 2012

Completed
Last Updated

March 7, 2016

Status Verified

March 1, 2016

Enrollment Period

5.8 years

First QC Date

February 15, 2012

Last Update Submit

March 3, 2016

Conditions

DiabetesDiabetes Mellitus, Type 1Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (6)

  • Occurrence of severe hypoglycaemic symptoms

    Year 1

  • Occurrence of severe hypoglycaemic symptoms

    Year 2 for patients who had an antibody titre test performed

  • Antibody titre findings

    Year 1

  • Antibody titre findings

    Year 2 for patients who had an antibody titre test performed

  • Adverse events

    Year 1

  • Adverse events

    Year 2 for patients who had an antibody titre test performed

Secondary Outcomes (6)

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

    Year 1

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

    Year 2 for patients who had an antibody titre test performed

  • HbA1c (glycosylated haemoglobin)

    Year 1

  • HbA1c (glycosylated haemoglobin)

    Year 2 for patients who had an antibody titre test performed

  • Total dose of insulin infused subcutaneously

    Year 1

  • +1 more secondary outcomes

Study Arms (1)

Insulin aspart users

Drug: insulin aspart

Interventions

insulin aspartDRUG

Prescribed by the physicians as a result of normal clinical practice

Insulin aspart users

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with diabetes requiring insulin therapy with no treatment history of insulin aspart (NovoRapid®)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Tokyo, 1000005, Japan

Location

Related Links

MeSH Terms

Conditions

Diabetes MellitusDiabetes Mellitus, Type 1Diabetes Mellitus, Type 2

Interventions

Insulin Aspart

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Short-ActingInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Global Clinical Registry (GCR, 1452)

    Novo Nordisk A/S

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 15, 2012

First Posted

February 24, 2012

Study Start

December 1, 2003

Primary Completion

October 1, 2009

Study Completion

October 1, 2009

Last Updated

March 7, 2016

Record last verified: 2016-03

Locations

JP(1)