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OpenTrials
Completed

NCT Number: NCT00670683

Observational Study of Patients With Diabetes Using Levemir® FlexPen®

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).

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Key information

Conditions

Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Pusan, 602-739, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diabetes Mellitus

Exclusion criteria

  • Contra-indication based on local label

Treatment and study plan

insulin detemir

Drug

Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation

Primary outcomes

  1. Incidence of adverse events

    Time frame: for the duration of the trial

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

Safety and Efficacy of Insulin Detemir (Levemir® FlexPen®) in Patients With Diabetes Mellitus

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
May 2, 2008
Registry last updated
Mar 3, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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