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

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: Ryzodeg®

• Registration Number: NCT04656106
• Lead Sponsor: Novo Nordisk A/S

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-11-30
• Study First Submitted QC: 2020-11-30
• Study First Posted: 2020-12-07
• Study Start: 2021-04-27
• Primary Completion: 2021-07-01
• Study Completion: 2021-07-01
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-27
• Last Update Posted: 2021-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Ryzodeg	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®.

Primary Outcome Measures

Name	Time	Method
Change in HbA1c (Glycosylated Hemoglobin)	Period 1 (week -26 to week 0), Period 2 (week 0 to week 26)	Percentage point

Secondary Outcome Measures

Name	Time	Method
Change in FPG (Fasting Plasma Glucose)	Period 1 (week -26 to week 0), Period 2 (week 0 to week 26)	mmol/L
Change in daily total insulin dose	Period 1 (week -26 to week 0), Period 2 (week 0 to week 26)	Unit/day
Change in daily basal insulin dose	Period 1 (week -26 to week 0), Period 2 (week 0 to week 26)	Unit/day
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)	Number of events
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)	Number of events
Patients with HbA1c less than 7.0 percentage (Yes or No)	End of study (week 26)	Percentage of patients
Patients with HbA1c less than 7 percentage without any hypoglycaemic events during the previous 26 weeks (Yes or No)	End of study (week 26)	Percentage of patients
Change in daily prandial insulin dose	Period 1 (week -26 to week 0), Period 2 (week 0 to week 26)	Unit/day
Change in body weight	Period 1 (week -26 to week 0), Period 2 (week 0 to week 26)	Kg

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇰🇷 Suwon-si, Gyeonggi-do, Korea, Republic of