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Observational Study of Patients With Diabetes Using Levemir® FlexPen®

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00670683
First Posted: May 2, 2008
Last Update Posted: March 3, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novo Nordisk A/S
  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 ]

Secondary Outcome Measures:
  • Weight [ Time Frame: for the duration of the trial ]
  • FBG (Fasting Blood Glucose) [ Time Frame: for the duration of the trial ]
  • 2hr-PPBG (2hr-Post Prandial Blood Glucose) [ Time Frame: for the duration of the trial ]
  • HbA1c [ Time Frame: for the duration of the trial ]
  • Adverse events [ Time Frame: for the duration of the trial ]
  • Clinical laboratory abnormality [ Time Frame: for the duration of the trial ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00670683


Locations
Korea, Republic of
Pusan, Korea, Republic of, 602-739
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00670683     History of Changes
Other Study ID Numbers: NN304-1914
First Submitted: April 30, 2008
First Posted: May 2, 2008
Last Update Posted: March 3, 2016
Last Verified: March 2016

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