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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 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: NCT03416855
Recruitment Status : Enrolling by invitation
First Posted : January 31, 2018
Last Update Posted : April 27, 2020
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:
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.

Condition or disease Intervention/treatment
Diabetes Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Drug: Insulin degludec /insulin aspart

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Study Type : Observational
Estimated Enrollment : 750 participants
Observational Model: Cohort
Time Perspective: Prospective
Official 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
Actual Study Start Date : January 31, 2018
Estimated Primary Completion Date : August 31, 2020
Estimated Study Completion Date : August 31, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Overall population
Participants will be decided to be treated with Ryzodeg® FlexTouch® by physicians before the enrolment in the study based on clinical judgement in the diabetes management.
Drug: Insulin degludec /insulin aspart
Commercially available Insulin degludec /insulin aspart (Ryzodeg® FlexTouch®) according to routine clinical practice at the discretion of the treating physician.
Other Name: Ryzodeg® FlexTouch®




Primary Outcome Measures :
  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 Outcome Measures :
  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



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.


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Ages Eligible for Study:   2 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with diabetes mellitus, who are scheduled to start treatment with Ryzodeg® FlexTouch® based on the clinical judgment of their treating physician as specified in the Korean-Prescribing information
Criteria
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

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): NCT03416855


Locations
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Korea, Republic of
Novo Nordisk Investigational Site
Busan, Korea, Republic of, 47392
Novo Nordisk Investigational Site
Busan, Korea, Republic of, 48575
Novo Nordisk Investigational Site
Busan, Korea, Republic of, 49267
Novo Nordisk Investigational Site
Busan, Korea, Republic of
Novo Nordisk Investigational Site
Daegu, Korea, Republic of
Novo Nordisk Investigational Site
Daejeon, Korea, Republic of, 330-721
Novo Nordisk Investigational Site
Daejeon, Korea, Republic of, 35015
Novo Nordisk Investigational Site
Daejeon, Korea, Republic of, 361-711
Novo Nordisk Investigational Site
Gangwon-do, Korea, Republic of, 26426
Novo Nordisk Investigational Site
Goyang, Korea, Republic of, 410-719
Novo Nordisk Investigational Site
Gyeonggi-do, Korea, Republic of, 10475
Novo Nordisk Investigational Site
Gyeonggi-do, Korea, Republic of, 14754
Novo Nordisk Investigational Site
Gyeonggi-do, Korea, Republic of
Novo Nordisk Investigational Site
Incheon, Korea, Republic of, 22332
Novo Nordisk Investigational Site
Jeonju, Korea, Republic of, 54987
Novo Nordisk Investigational Site
Jeonju, Korea, Republic of, 561-712
Novo Nordisk Investigational Site
Pusan, Korea, Republic of, 602-739
Novo Nordisk Investigational Site
Pyungchon-Dong 896, Dongan-Gu, Korea, Republic of, 431-796
Novo Nordisk Investigational Site
Seoul, Korea, Republic of, 01450
Novo Nordisk Investigational Site
Seoul, Korea, Republic of, 04564
Novo Nordisk Investigational Site
Seoul, Korea, Republic of, 05355
Novo Nordisk Investigational Site
Seoul, Korea, Republic of, 07354
Novo Nordisk Investigational Site
Seoul, Korea, Republic of, 139-827
Novo Nordisk Investigational Site
Seoul, Korea, Republic of
Novo Nordisk Investigational Site
Suwon-si, Gyeonggi-do, Korea, Republic of, 16247
Novo Nordisk Investigational Site
Suwon, Korea, Republic of, 16499
Novo Nordisk Investigational Site
Ulsan, Korea, Republic of, 682-060
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Clinical Reporting Anchor and Disclosure (1452) Novo Nordisk A/S
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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT03416855    
Other Study ID Numbers: NN5401-4196
1111-1194-8505 ( Other Identifier: World Health Organization (WHO) )
First Posted: January 31, 2018    Key Record Dates
Last Update Posted: April 27, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
URL: http://www.novonordisk-trials.com/website/content/how-to-access-clinical-trial-datasets.aspx

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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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 Aspart
Hypoglycemic Agents
Physiological Effects of Drugs