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Completed

NCT Number: NCT04656106

A Study Investigating the Clinical Parameters Associated With the Use of Ryzodeg® (Insulin Degludec/Insulin Aspart) in a Real-world Adult Population With Type 2 Diabetes in South Korea

This is a non-interventional (observational), retrospective medical record review study collecting data reported in medical records of patients with T2D (Type 2 Diabetes ) who were treated with any basal-insulin or premix-insulin (plus/minus OAD (Oral Antidiabetic Drug)) for at least 26 weeks prior to switching to Ryzodeg® and treated for at least 26 weeks after switching to Ryzodeg® (plus/minus OAD).

All patients have been treated at the discretion of the treating physician in accordance with the Ryzodeg® label in South Korea.

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Key information

Conditions

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

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Novo Nordisk Investigational Site, Daejeon, South Korea

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Who can participate

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

Inclusion criteria

  • Male or female, age above or equal to 19 years at the time of Ryzodeg® initiation
  • Type 2 diabetes mellitus patients
  • Treated with any basal-insulin (plus/minus OAD (Oral Antidiabetic Drug)) or premix-insulin (plus/minus OAD) for at least 26 weeks prior to switching to Ryzodeg®
  • Treated with Ryzodeg® (plus/minus OAD) for at least 26 weeks after switch from any basal insulin (plus/minus OAD) or premix insulin (plus/minus OAD)
  • At least more than once documented medical visit for 26weeks (plus/minus 6 weeks) after Ryzodeg® initiation
  • Minimum available data : age, type of diabetes at the time of Ryzodeg® initiation, HbA1c [Three values: most recent value within 26 weeks (plus/minus 6 weeks) prior to Ryzodeg® initiation, a value of Ryzodeg® initiation date (plus/minus 6 week), and a value in the first 26 weeks (plus/minus 6 weeks) after Ryzodeg® initiation]
  • The decision to treat with Ryzodeg® was taken by treating physician independently from decision to include patient in study.

Exclusion criteria

  • Patients treated with any diabetic investigational drug within 26 weeks before or after the initiation of Ryzodeg®
  • Patients switching to Ryzodeg® below 26 weeks prior to the data collection date
  • Patients not treated with any basal-insulin or premix-insulin at least 26 weeks prior to receiving Ryzodeg®
  • Patients treated by continuous subcutaneous insulin infusion prior to receiving Ryzodeg®
  • Pregnancy patient
  • Patients not treated with the local licensed Ryzodeg®

Treatment and study plan

Ryzodeg®

Drug

All patients have been treated at the discretion of the treating physician in accordance with the Ryzodeg® label in South Korea. Hence independently of this study, the treating physician has determined the starting dose of Ryzodeg® as well as any dose adjustments thereafter.

Primary outcomes

  1. Change in HbA1c (Glycosylated Hemoglobin)

    Time frame: Period 1 (week -26 to week 0), Period 2 (week 0 to week 26)

    Percentage point

Secondary outcomes

  1. Patients with HbA1c less than 7.0 percentage (Yes or No)

    Time frame: At baseline (week 0)

    Percentage of patients

  2. Patients with HbA1c less than 7.0 percentage (Yes or No)

    Time frame: End of study (week 26)

    Percentage of patients

  3. Patients with HbA1c less than 7 percentage without any hypoglycaemic events during the previous 26 weeks (Yes or No)

    Time frame: At baseline (week 0)

    Percentage of patients

  4. Patients with HbA1c less than 7 percentage without any hypoglycaemic events during the previous 26 weeks (Yes or No)

    Time frame: End of study (week 26)

    Percentage of patients

  5. Difference in the number of overall hypoglycaemia events within 26 weeks before and after the switch to Ryzodeg®

    Time frame: Period 1(week-26 to week 0), Period 2(week 0 to week 26)

    Number of events

  6. Difference in the number of severe hypoglycaemia events within 26 weeks before and after the switch to Ryzodeg®

    Time frame: Period 1(week-26 to week 0), Period 2(week 0 to week 26)

    Number of events

  7. Change in FPG (Fasting Plasma Glucose)

    Time frame: Period 1 (week -26 to week 0), Period 2 (week 0 to week 26)

    mmol/L

  8. Change in daily total insulin dose

    Time frame: Period 1 (week -26 to week 0), Period 2 (week 0 to week 26)

    Unit/day

  9. Change in daily basal insulin dose

    Time frame: Period 1 (week -26 to week 0), Period 2 (week 0 to week 26)

    Unit/day

  10. Change in daily prandial insulin dose

    Time frame: Period 1 (week -26 to week 0), Period 2 (week 0 to week 26)

    Unit/day

  11. Change in body weight

    Time frame: Period 1 (week -26 to week 0), Period 2 (week 0 to week 26)

    Kg

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

A Retrospective Multi-centre Non-interventional Study Investigating the Clinical Parameters Associated With the Use of Ryzodeg® (Insulin Degludec/Insulin Aspart) in a Real-world Adult Population With Type 2 Diabetes in South Korea

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Dec 7, 2020
Registry last updated
Sep 28, 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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