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Completed

NCT Number: NCT02779413

A Study to Evaluate Safety and Effectiveness in Patients of All Age Groups Excluding Less Than 12 Months Old Infants With Diabetes Mellitus in Routine Clinical Practice in Korea

This study is conducted in Asia. The aim of the study is to evaluate safety and effectiveness in patients of all age groups excluding less than 12 month old infants with diabetes mellitus in routine clinical practice in Korea.

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Key information

Age range

12 month and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Novo Nordisk Investigational Site, Bucheon-si, South Korea

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

- Signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol) - The decision to initiate treatment with commercially available Tresiba® FlexTouch® has been made by the patient/Legally Acceptable Representative (LAR) and the treating physician before and independently from the decision to include the patient in this study - Male or Female, Age at least 12 months, at the time of signing informed consent with type 1 or type 2 diabetes mellitus and who is scheduled to start treatment with Tresiba® FlexTouch® based on the clinical judgment of their treating physician as specified in the Korean-Prescribing Information (KPI) Exclusion Criteria: - Previous participation in this study. Participation is defined as having given informed consent in this study - Patients who are or have previously treated with Tresiba® FlexTouch® - Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation. However, paediatric patients can be enrolled when the patient's primary caregiver (e.g. parents) or legally acceptable representatives (LAR) are capable of giving study specific signed informed consent. Any chronic disorder or severe disease which in the opinion of the investigator might jeopardise patient's safety or compliance with the protocol - Female who is pregnant, breast-feeding or intends to become pregnant and is of child-baring potential and not using adequate contraceptive methods (adequate contraceptive measures as required by local regulation or practice)

Treatment and study plan

insulin degludec

Drug

Patients will be treated with commercially available Tresiba® FlexTouch® according to routine clinical practice at the discretion of the treating physician.

Primary outcomes

  1. Number of Adverse Events (AE)

    Time frame: Week 13± 2 weeks

  2. Number of Adverse Events (AE)

    Time frame: week 26± 2 weeks

Secondary outcomes

  1. Insulin dose changes

    Time frame: Week 0, Week 26

  2. Change in HbA1c

    Time frame: Week 0, week 13, week 26

  3. Percentage of patients achieving the target of HbA1c below 7.0%

    Time frame: At week 13

  4. Percentage of patients achieving the target of HbA1c below 7.0%

    Time frame: At week 26

  5. Change in fasting plasma glucose (FPG)

    Time frame: Week 0, week 13, week 26

  6. Changes in postprandial plasma glucose (PPG)

    Time frame: Week 0, week 13, week 26

  7. Number of Adverse reactions (AR)

    Time frame: Week 13± 2 weeks

  8. Number of Adverse reactions (AR)

    Time frame: week 26± 2 weeks

  9. Number of Serious AE

    Time frame: Week 13± 2 weeks

  10. Number of Serious AE

    Time frame: week 26± 2 weeks

  11. Number of Serious AR

    Time frame: Week 13± 2 weeks

  12. Number of Serious AR

    Time frame: week 26± 2 weeks

  13. Number of Unexpected AR

    Time frame: Week 13± 2 weeks

  14. Number of Unexpected AR

    Time frame: week 26± 2 weeks

  15. Number of Severe hypoglycaemia (PG (plasma glucose) below 56 mg/dl)

    Time frame: Week 13± 2 weeks

  16. Number of Severe hypoglycaemia (PG (plasma glucose) below 56 mg/dl)

    Time frame: week 26± 2 weeks

  17. Number of Blood glucose (BG) confirmed hypoglycaemia (PG below 56 mg/dl)

    Time frame: Week 13± 2 weeks

  18. Number of Blood glucose (BG) confirmed hypoglycaemia (PG below 56 mg/dl)

    Time frame: week 26± 2 weeks

  19. Weight gain

    Time frame: week 13 ± 2 weeks

  20. Weight gain

    Time frame: week 26± 2 weeks

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

A Multi-centre, Prospective, Open-label, Single-arm, Non-interventional, Regulatory Post Marketing Surveillance (rPMS) Study of Tresiba® FlexTouch® (Insulin Degludec) to Evaluate Safety and Effectiveness in Patients of All Age Groups Excluding Less Than 12 Months Old Infants With Diabetes Mellitus in Routine Clinical Practice in Korea

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
May 20, 2016
Registry last updated
Apr 21, 2020

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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