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Observational Study of Patients With Diabetes Using Levemir® FlexPen®

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.
ClinicalTrials.gov Identifier: NCT00670683
Recruitment Status : Completed
First Posted : May 2, 2008
Last Update Posted : March 3, 2016
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment
Diabetes Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Drug: insulin detemir

Study Type : Observational
Actual Enrollment : 797 participants
Time Perspective: Prospective
Official Title: Safety and Efficacy of Insulin Detemir (Levemir® FlexPen®) in Patients With Diabetes Mellitus
Study Start Date : July 2007
Primary Completion Date : September 2009
Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
A Drug: insulin detemir
Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation

Primary Outcome Measures :
  1. Incidence of adverse events [ Time Frame: for the duration of the trial ]

Secondary Outcome Measures :
  1. Weight [ Time Frame: for the duration of the trial ]
  2. FBG (Fasting Blood Glucose) [ Time Frame: for the duration of the trial ]
  3. 2hr-PPBG (2hr-Post Prandial Blood Glucose) [ Time Frame: for the duration of the trial ]
  4. HbA1c [ Time Frame: for the duration of the trial ]
  5. Adverse events [ Time Frame: for the duration of the trial ]
  6. Clinical laboratory abnormality [ Time Frame: for the duration of the trial ]

Information from the National Library of Medicine

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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

Inclusion Criteria:

  • Diabetes Mellitus

Exclusion Criteria:

  • Contra-indication based on local label

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

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

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00670683     History of Changes
Other Study ID Numbers: NN304-1914
First Posted: May 2, 2008    Key Record Dates
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 Detemir
Hypoglycemic Agents
Physiological Effects of Drugs