Observational Study of Patients With Diabetes Using Levemir® FlexPen®

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00670683
First received: April 30, 2008
Last updated: July 24, 2012
Last verified: July 2012
  Purpose

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).


Condition Intervention
Diabetes
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Drug: insulin detemir

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Safety and Efficacy of Insulin Detemir (Levemir® FlexPen®) in Patients With Diabetes Mellitus

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Incidence of adverse events [ Time Frame: for the duration of the trial ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Weight [ Time Frame: for the duration of the trial ] [ Designated as safety issue: Yes ]
  • FBG (Fasting Blood Glucose) [ Time Frame: for the duration of the trial ] [ Designated as safety issue: No ]
  • 2hr-PPBG (2hr-Post Prandial Blood Glucose) [ Time Frame: for the duration of the trial ] [ Designated as safety issue: No ]
  • HbA1c [ Time Frame: for the duration of the trial ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: for the duration of the trial ] [ Designated as safety issue: Yes ]
  • Clinical laboratory abnormality [ Time Frame: for the duration of the trial ] [ Designated as safety issue: No ]

Enrollment: 797
Study Start Date: July 2007
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
A Drug: insulin detemir
Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Diabetic patients

Criteria

Inclusion Criteria:

  • Diabetes Mellitus

Exclusion Criteria:

  • Contra-indication based on local label
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00670683

Locations
Korea, Republic of
Pusan, Korea, Republic of, 602-739
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: So Ra Lee, MD Novo Nordisk Pharma Korea Ltd.
  More Information

Additional Information:
No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00670683     History of Changes
Other Study ID Numbers: NN304-1914
Study First Received: April 30, 2008
Last Updated: July 24, 2012
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 15, 2014