NCT04656106|Completed

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

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/S ClinicalTrials.gov

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2 other identifiers

NN5401-4653U1111-1257-2534

Study Type

observational

Target

200

Locations

1 country

Sites

Timeline

RegisteredDec 2020

StartedApr 2021

CompletionJul 2021

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

200

participants targeted

Target at P75+ for all trials

Timeline

Completed

Started Apr 2021

Shorter than P25 for all trials

Geographic Reach

1 country

6 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2 months study duration

First Submitted

Initial submission to the registry

November 30, 2020

Completed

7 days until next milestone

First Posted

Study publicly available on registry

December 7, 2020

Completed

5 months until next milestone

Study Start

First participant enrolled

April 27, 2021

Completed

2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2021

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2021

Completed

Last Updated

September 28, 2021

Status Verified

September 1, 2021

Enrollment Period

2 months

First QC Date

November 30, 2020

Last Update Submit

September 27, 2021

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (11)

Patients with HbA1c less than 7.0 percentage (Yes or No)
At baseline (week 0)
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)
At baseline (week 0)
Patients with HbA1c less than 7 percentage without any hypoglycaemic events during the previous 26 weeks (Yes or No)
End of study (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)
+6 more secondary outcomes

Study Arms (1)

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®.

Drug: Ryzodeg®

Interventions

Ryzodeg®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.

Ryzodeg

Eligibility Criteria

Age19 Years+

Sexall

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

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®.

You may qualify if:

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.

You may not qualify if:

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®

Contact the study team to confirm eligibility.