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

September 27, 2021 updated by: Novo Nordisk A/S

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Daejeon, Korea, Republic of, 361-711
        • Novo Nordisk Investigational Site
      • Daejeon, Korea, Republic of, 330-721
        • Novo Nordisk Investigational Site
      • Seongnam-si, Korea, Republic of, 463-707
        • Novo Nordisk Investigational Site
      • Seoul, Korea, Republic of, 03181
        • Novo Nordisk Investigational Site
      • Seoul, Korea, Republic of, 06273
        • Novo Nordisk Investigational Site
      • Suwon-si, Gyeonggi-do, Korea, Republic of, 16247
        • Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients treated with any basal-insulin or premix-insulin for at least 26 weeks prior to switching to Ryzodeg® and treated for at least 26 weeks after switching to Ryzodeg®.

Description

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®

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Ryzodeg
Patients treated with any basal-insulin or premix-insulin for at least 26 weeks prior to switching to Ryzodeg® and treated for at least 26 weeks after switching to Ryzodeg®.
Drug: Ryzodeg®
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in HbA1c (Glycosylated Hemoglobin)
Time Frame: Period 1 (week -26 to week 0), Period 2 (week 0 to week 26)
Percentage point
Period 1 (week -26 to week 0), Period 2 (week 0 to week 26)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patients with HbA1c less than 7.0 percentage (Yes or No)
Time Frame: At baseline (week 0)
Percentage of patients
At baseline (week 0)
Patients with HbA1c less than 7.0 percentage (Yes or No)
Time Frame: End of study (week 26)
Percentage of patients
End of study (week 26)
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
At baseline (week 0)
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
End of study (week 26)
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
Period 1(week-26 to week 0), Period 2(week 0 to week 26)
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
Period 1(week-26 to week 0), Period 2(week 0 to week 26)
Change in FPG (Fasting Plasma Glucose)
Time Frame: Period 1 (week -26 to week 0), Period 2 (week 0 to week 26)
mmol/L
Period 1 (week -26 to week 0), Period 2 (week 0 to week 26)
Change in daily total insulin dose
Time Frame: Period 1 (week -26 to week 0), Period 2 (week 0 to week 26)
Unit/day
Period 1 (week -26 to week 0), Period 2 (week 0 to week 26)
Change in daily basal insulin dose
Time Frame: Period 1 (week -26 to week 0), Period 2 (week 0 to week 26)
Unit/day
Period 1 (week -26 to week 0), Period 2 (week 0 to week 26)
Change in daily prandial insulin dose
Time Frame: Period 1 (week -26 to week 0), Period 2 (week 0 to week 26)
Unit/day
Period 1 (week -26 to week 0), Period 2 (week 0 to week 26)
Change in body weight
Time Frame: Period 1 (week -26 to week 0), Period 2 (week 0 to week 26)
Kg
Period 1 (week -26 to week 0), Period 2 (week 0 to week 26)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 27, 2021

Primary Completion (Actual)

July 1, 2021

Study Completion (Actual)

July 1, 2021

Study Registration Dates

First Submitted

November 30, 2020

First Submitted That Met QC Criteria

November 30, 2020

First Posted (Actual)

December 7, 2020

Study Record Updates

Last Update Posted (Actual)

September 28, 2021

Last Update Submitted That Met QC Criteria

September 27, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN5401-4653
  • U1111-1257-2534 (Other Identifier: World Health Organization (WHO))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diabetes Mellitus, Type 2

Clinical Trials on Ryzodeg®

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mozambique

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe