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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 21, 2014