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Completed

NCT Number: NCT03416855

A Regulatory Post Marketing Surveillance (rPMS) Study of Ryzodeg® FlexTouch® (Insulin Degludec /Insulin Aspart) to Evaluate Safety and Effectiveness in Patients With Diabetes Mellitus in Routine Clinical Practice in Korea

The purpose of this study is to collect information about safety and effectiveness of Ryzodeg® FlexTouch® in participants with diabetes mellitus requiring insulin therapy under routine clinical practice conditions with the aim of identifying or quantifying a safety hazard, early detection of unknown safety problems. Participants will attend the clinic/hospital/medical institution according to usual practice and receive medical care, as agreed with the study doctor.

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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

Age range

2 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Novo Nordisk Investigational Site, Busan, 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

- The decision to initiate treatment with commercially available Ryzodeg® 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 - Signed informed consent obtained before any study related activities. Study related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study - Age equals to or more than 2 years at the time of signing informed consent with diabetes mellitus (Type 1 or Type 2) and who is scheduled to start treatment with Ryzodeg® FlexTouch® based on the clinical judgment of their treating physician as specified in the Korean-Prescribing information (K-PI) Exclusion Criteria: - Patients who are or have previously been on Ryzodeg® FlexTouch® therapy - Known or suspected hypersensitivity to Ryzodeg® FlexTouch®, the active substance or any of the excipients - Previous participation in this study. Participation is defined as having given informed consent in this study - Female patient who is pregnant, breast-feeding or intends to become pregnant and is of childbearing potential and not using adequate contraceptive methods(adequate contraceptive measures as required by Korea regulation or practice) - Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation

Treatment and study plan

Insulin degludec /insulin aspart

Drug

Commercially available Insulin degludec /insulin aspart (Ryzodeg® FlexTouch®) according to routine clinical practice at the discretion of the treating physician.

Other names: Ryzodeg® FlexTouch®

Primary outcomes

  1. Number of Adverse events (AEs) at week 13

    Time frame: week 13 (± 2 weeks)

    Count of events

  2. Number of patients with AEs at week 13

    Time frame: week 13 (± 2 weeks)

    Number of patients

  3. Percentage of patients with AEs at week 13

    Time frame: week 13 (± 2 weeks)

    Percentage of patients

  4. Number of Adverse events (AEs) at week 26

    Time frame: week 26 (± 2 weeks)

    Count of events

  5. Number of patients with AEs at week 26

    Time frame: week 26 (± 2 weeks)

    Number of patients

  6. Percentage of patients with AEs at week 26

    Time frame: week 26 (± 2 weeks)

    Percentage of patients

Secondary outcomes

  1. Number of patients with Adverse Drug Reaction (ADR) at week 13

    Time frame: week 13 (± 2 weeks)

    Number of patients

  2. Percentage of Patients with ADR at week 13

    Time frame: week 13 (± 2 weeks)

    Percentage of patients

  3. Number of Patients with ADR at week 26

    Time frame: week 26 (± 2 weeks)

    Number of patients

  4. Percentage of Patients with ADR at week 26

    Time frame: week 26 (± 2 weeks)

    Percentage of patients

  5. Number of patients with Serious AE/ADR at week 13

    Time frame: week 13 (± 2 weeks)

    Number of patients

  6. Percentage of patients with Serious AE/ADR at week 13

    Time frame: week 13 (± 2 weeks)

    Percentage of patients

  7. Number of patients with Serious AE/ADR at week 26

    Time frame: week 26 (± 2 weeks)

    Number of patients

  8. Percentage of patients with Serious AE/ADR at week 26

    Time frame: week 26 (± 2 weeks)

    Percentage of patients

  9. Number of patients with unexpected ADR at week 13

    Time frame: week 13 (± 2 weeks)

    Number of patients

  10. Percentage of patients with unexpected ADR at week 13

    Time frame: week 13 (± 2 weeks)

    Percentage of patients

  11. Number of subjects with unexpected ADR at week 26

    Time frame: week 26 (± 2 weeks)

    Number of subjects

  12. Percentage of patients with unexpected ADR at week 26

    Time frame: week 26 (± 2 weeks)

    Percentage of patients

  13. Number of patients with Severe or Blood Glucose (BG) confirmed hypoglycaemia (Plasma Glucose <56 mg/dl) at week 13

    Time frame: week 13 (± 2 weeks)

    Number of patients

  14. Percentage of patients with Severe or BG confirmed hypoglycaemia (Plasma Glucose <56 mg/dl) at week 13

    Time frame: week 13 (± 2 weeks)

    Percentage of patients

  15. Number of patients with Severe or BG confirmed hypoglycaemia (Plasma Glucose <56 mg/dl) at week 26

    Time frame: week 26 (± 2 weeks)

    Number of patients

  16. Percentage of patients with Severe or BG confirmed hypoglycaemia (Plasma Glucose <56 mg/dl) at week 26

    Time frame: week 26 (± 2 weeks)

    Percentage of patients

  17. Change from baseline in body weight at week 13

    Time frame: week 0, week 13 (± 2 weeks)

    Measured in kg

  18. Change from baseline in body weight at week 26

    Time frame: week 0, week 26 (± 2 weeks)

    Measured in kg

  19. Insulin dose at week 13

    Time frame: week 13 (± 2 weeks)

    Dose in Units

  20. Insulin dose at week 26

    Time frame: week 26 (± 2 weeks)

    Dose in Units

  21. Change from baseline in HbA1c after 13 weeks of treatment

    Time frame: week 0, week 13 (± 2 weeks)

    Measured in %

  22. Change from baseline in HbA1c after 26 weeks of treatment

    Time frame: week 0, week 26 (± 2 weeks)

    Measured in %

  23. Percentage of patients achieving the target of HbA1c < 7.0% at 13 weeks of treatment

    Time frame: week 13 (± 2 weeks)

    Percentage of patients

  24. Percentage of patients achieving the target of HbA1c < 7.0% at 26 weeks of treatment

    Time frame: week 26 (± 2 weeks)

    Percentage of patients

  25. Change from baseline in Fasting Blood Glucose/Plasma Glucose (FBG/FPG) after 13 weeks treatment

    Time frame: week 0, week 13 (± 2 weeks)

    Measured in mg/dl or other equivalent SI units

  26. Change from baseline in FBG/FPG after 26 weeks treatment

    Time frame: week 0, week 26 (± 2 weeks)

    Measured in mg/dl or other equivalent SI units

  27. Changes from baseline in Post Prandial Blood/Plasma Glucose (PPBG/PPPG) after 13 weeks treatment

    Time frame: week 0, week 13 (± 2 weeks)

    Measured in mg/dl or other equivalent SI units

  28. Changes from baseline in PPBG/PPPG after 26 weeks treatment

    Time frame: week 0, week 26 (± 2 weeks)

    Measured in mg/dl or other equivalent SI units

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 Ryzodeg® FlexTouch® (Insulin Degludec /Insulin Aspart) to Evaluate Safety and Effectiveness in Patients With Diabetes Mellitus in Routine Clinical Practice in Korea

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jan 31, 2018
Registry last updated
Nov 10, 2021

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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