Observational Study of Patients With Diabetes Using Levemir® FlexPen®

Safety and Efficacy of Insulin Detemir (Levemir® FlexPen®) in Patients With Diabetes Mellitus

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00670683

Enrollment

797

Registered

2008-05-02

Start date

2007-07-31

Completion date

2009-09-30

Last updated

2016-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2

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).

Interventions

DRUGinsulin detemir

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

Study design

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

* Diabetes Mellitus

Exclusion criteria

* Contra-indication based on local label

Design outcomes

Primary

Measure	Time frame
Incidence of adverse events	for the duration of the trial

Secondary

Measure	Time frame
FBG (Fasting Blood Glucose)	for the duration of the trial
2hr-PPBG (2hr-Post Prandial Blood Glucose)	for the duration of the trial
Weight	for the duration of the trial
Adverse events	for the duration of the trial
Clinical laboratory abnormality	for the duration of the trial
HbA1c	for the duration of the trial

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026