NCT01487408

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,463

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2002

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

April 1, 2002

Completed
7.5 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
2.2 years until next milestone

First Submitted

Initial submission to the registry

November 29, 2011

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 7, 2011

Completed
Last Updated

March 4, 2016

Status Verified

March 1, 2016

Enrollment Period

7.5 years

First QC Date

November 29, 2011

Last Update Submit

March 3, 2016

Conditions

DiabetesDiabetes Mellitus, Type 1Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

  • HbA1c (glycosylated haemoglobin)

Secondary Outcomes (4)

  • Incidence of servere hypoglycaemia

  • Total dose of insulin (aspart/human insulin) infused subcutaneously

  • Physical examination

  • Adverse events

Study Arms (1)

Insulin Aspart

Drug: insulin aspart

Interventions

insulin aspartDRUG

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

Insulin Aspart

Eligibility Criteria

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

Patients with type 1 or type 2 diabetes.

You may qualify if:

  • Patients with diabetes requiring insulin therapy

You may not qualify if:

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

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

November 29, 2011

First Posted

December 7, 2011

Study Start

April 1, 2002

Primary Completion

October 1, 2009

Study Completion

October 1, 2009

Last Updated

March 4, 2016

Record last verified: 2016-03

Locations

JP(1)