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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-04-27

Study Completion Date

2021-07-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Diabetes Mellitus, Type 2

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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®.

Ryzodeg®

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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®

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No