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

Novo Nordisk

Status: Completed

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Ryzodeg®

Study type: Observational

Funder types: Industry

Identifiers

NCT04656106

NN5401-4653

U1111-1257-2534 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 200 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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®

Trial design

200 participants in 1 patient group

Ryzodeg

Description:

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®.

Treatment:

Drug: Ryzodeg®