NCT00670683

Brief Summary

This study is conducted in Asia. This study is a prospective, open, uncontrolled, observational surveillance study with Levemir® FlexPen® conducted in Korea. The aim of this observational study is to evaluate the short term and the long term safety and efficacy of Levemir® FlexPen®. The study is planned and conducted as per requirement from Korea Food and Drug Administration (KFDA).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
797

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2007

Typical duration 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

July 1, 2007

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

April 30, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 2, 2008

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

March 3, 2016

Status Verified

March 1, 2016

Enrollment Period

2.2 years

First QC Date

April 30, 2008

Last Update Submit

March 2, 2016

Conditions

DiabetesDiabetes Mellitus, Type 1Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

  • Incidence of adverse events

    for the duration of the trial

Secondary Outcomes (6)

  • Weight

    for the duration of the trial

  • FBG (Fasting Blood Glucose)

    for the duration of the trial

  • 2hr-PPBG (2hr-Post Prandial Blood Glucose)

    for the duration of the trial

  • HbA1c

    for the duration of the trial

  • Adverse events

    for the duration of the trial

  • +1 more secondary outcomes

Study Arms (1)

A

Drug: insulin detemir

Interventions

insulin detemirDRUG

Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation

A

Eligibility Criteria

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

Diabetic patients

You may qualify if:

  • Diabetes Mellitus

You may not qualify if:

  • Contra-indication based on local label

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Pusan, 602-739, South Korea

Location

Related Links

MeSH Terms

Conditions

Diabetes MellitusDiabetes Mellitus, Type 1Diabetes Mellitus, Type 2

Interventions

Insulin Detemir

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Insulin, Long-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
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 30, 2008

First Posted

May 2, 2008

Study Start

July 1, 2007

Primary Completion

September 1, 2009

Study Completion

September 1, 2009

Last Updated

March 3, 2016

Record last verified: 2016-03

Locations

KR(1)