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

Diabetes Mellitus, Type 2 Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04656106
• Other study ID #: NN5401-4653
• Secondary ID: U1111-1257-2534
• Status: Completed
• Start date: April 27, 2021
• Est. completion date: July 1, 2021

Study information

• Verified date: September 2021
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: July 1, 2021
• Est. primary completion date: July 1, 2021
• Gender: All
• Age group: 19 Years and older

Eligibility

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®

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Novo Nordisk Investigational Site	Daejeon
Korea, Republic of	Novo Nordisk Investigational Site	Daejeon
Korea, Republic of	Novo Nordisk Investigational Site	Seongnam-si
Korea, Republic of	Novo Nordisk Investigational Site	Seoul
Korea, Republic of	Novo Nordisk Investigational Site	Seoul
Korea, Republic of	Novo Nordisk Investigational Site	Suwon-si, Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in HbA1c (Glycosylated Hemoglobin)	Percentage point	Period 1 (week -26 to week 0), Period 2 (week 0 to week 26)
Secondary	Patients with HbA1c less than 7.0 percentage (Yes or No)	Percentage of patients	At baseline (week 0)
Secondary	Patients with HbA1c less than 7.0 percentage (Yes or No)	Percentage of patients	End of study (week 26)
Secondary	Patients with HbA1c less than 7 percentage without any hypoglycaemic events during the previous 26 weeks (Yes or No)	Percentage of patients	At baseline (week 0)
Secondary	Patients with HbA1c less than 7 percentage without any hypoglycaemic events during the previous 26 weeks (Yes or No)	Percentage of patients	End of study (week 26)
Secondary	Difference in the number of overall hypoglycaemia events within 26 weeks before and after the switch to Ryzodeg®	Number of events	Period 1(week-26 to week 0), Period 2(week 0 to week 26)
Secondary	Difference in the number of severe hypoglycaemia events within 26 weeks before and after the switch to Ryzodeg®	Number of events	Period 1(week-26 to week 0), Period 2(week 0 to week 26)
Secondary	Change in FPG (Fasting Plasma Glucose)	mmol/L	Period 1 (week -26 to week 0), Period 2 (week 0 to week 26)
Secondary	Change in daily total insulin dose	Unit/day	Period 1 (week -26 to week 0), Period 2 (week 0 to week 26)
Secondary	Change in daily basal insulin dose	Unit/day	Period 1 (week -26 to week 0), Period 2 (week 0 to week 26)
Secondary	Change in daily prandial insulin dose	Unit/day	Period 1 (week -26 to week 0), Period 2 (week 0 to week 26)
Secondary	Change in body weight	Kg	Period 1 (week -26 to week 0), Period 2 (week 0 to week 26)