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

Novo Nordisk A/S1 site in 1 country200 target enrollmentApril 27, 2021

ConditionsDiabetes Mellitus, Type 2

InterventionsRyzodeg®

DrugsRyzodeg®

Overview

Phase: Not Applicable
Intervention: Ryzodeg®
Conditions: Diabetes Mellitus, Type 2
Sponsor: Novo Nordisk A/S
Enrollment: 200
Locations: 1
Primary Endpoint: Change in HbA1c (Glycosylated Hemoglobin)
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

April 27, 2021

End Date

July 1, 2021

Last Updated

4 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Novo Nordisk A/S

Responsible Party

Sponsor

Eligibility Criteria

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®

Arms & Interventions

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®.

Intervention: Ryzodeg®

Outcomes

Primary Outcomes

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

Change in FPG (Fasting Plasma Glucose)(Period 1 (week -26 to week 0), Period 2 (week 0 to week 26))
Change in daily total insulin dose(Period 1 (week -26 to week 0), Period 2 (week 0 to week 26))
Change in daily basal insulin dose(Period 1 (week -26 to week 0), Period 2 (week 0 to week 26))
Difference in the number of overall hypoglycaemia events within 26 weeks before and after the switch to Ryzodeg®(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®(Period 1(week-26 to week 0), Period 2(week 0 to week 26))
Patients with HbA1c less than 7.0 percentage (Yes or No)(End of study (week 26))
Patients with HbA1c less than 7 percentage without any hypoglycaemic events during the previous 26 weeks (Yes or No)(End of study (week 26))
Change in daily prandial insulin dose(Period 1 (week -26 to week 0), Period 2 (week 0 to week 26))
Change in body weight(Period 1 (week -26 to week 0), Period 2 (week 0 to week 26))