NCT01492959

Brief Summary

This study is conducted in Asia. The aim of this study is to review the efficacy and safety of insulin treatment with InnoLet® in daily clinical practice.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,030

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2004

Shorter than P25 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

March 23, 2004

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 23, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 23, 2005

Completed
6.7 years until next milestone

First Submitted

Initial submission to the registry

December 9, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 15, 2011

Completed
Last Updated

February 28, 2017

Status Verified

February 1, 2017

Enrollment Period

1 year

First QC Date

December 9, 2011

Last Update Submit

February 27, 2017

Conditions

DiabetesDiabetes Mellitus, Type 1Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

  • Change in HbA1c (glycosylated haemoglobin)

Secondary Outcomes (1)

  • Adverse events: Serious and non-serious

Study Arms (1)

Insulin human

Drug: insulin human

Interventions

insulin humanDRUG

Insulin human delivered with the InnoLet® device was prescribed according to product labelling to subjects in need of insulin treatment

Insulin human

Eligibility Criteria

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

Korean patients with diabetes mellitus in need of insulin treatment

You may qualify if:

  • Diabetes mellitus (Type 1 or type 2)
  • Need insulin treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novo Nordisk Investigational Site

Seoul, 137-920, South Korea

Location

Related Links

MeSH Terms

Conditions

Diabetes MellitusDiabetes Mellitus, Type 1Diabetes Mellitus, Type 2

Interventions

Insulin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

ProinsulinInsulinsPancreatic 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

December 9, 2011

First Posted

December 15, 2011

Study Start

March 23, 2004

Primary Completion

March 23, 2005

Study Completion

March 23, 2005

Last Updated

February 28, 2017

Record last verified: 2017-02

Locations

KR(1)