Observational Study of Patients With Diabetes Using Levemir® FlexPen®

Completed

• Conditions: Diabetes Mellitus, Type 1; Diabetes; Diabetes Mellitus, Type 2
• Interventions: Drug: insulin detemir

• Registration Number: NCT00670683
• Lead Sponsor: Novo Nordisk A/S

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2007-07
• Study First Submitted: 2008-04-30
• Study First Submitted QC: 2008-04-30
• Study First Posted: 2008-05-02
• Primary Completion: 2009-09
• Study Completion: 2009-09
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-02
• Last Update Posted: 2016-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 797

Inclusion Criteria

• Diabetes Mellitus

Exclusion Criteria

• Contra-indication based on local label

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
A	insulin detemir	-

Primary Outcome Measures

Name	Time	Method
Incidence of adverse events	for the duration of the trial

Secondary Outcome Measures

Name	Time	Method
FBG (Fasting Blood Glucose)	for the duration of the trial
Adverse events	for the duration of the trial
Clinical laboratory abnormality	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
HbA1c	for the duration of the trial