Clinical trial NCT04656106: 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
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2020-12-07
Enrollment: 200
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_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®.

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.


Eligibility criteria: 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®

Primary outcomes:
measure: Change in HbA1c (Glycosylated Hemoglobin)
timeFrame: Period 1 (week -26 to week 0), Period 2 (week 0 to week 26)
Secondary outcomes:
measure: Patients with HbA1c less than 7.0 percentage (Yes or No)
timeFrame: At baseline (week 0)
measure: Patients with HbA1c less than 7.0 percentage (Yes or No)
timeFrame: End of study (week 26)
measure: Patients with HbA1c less than 7 percentage without any hypoglycaemic events during the previous 26 weeks (Yes or No)
timeFrame: At baseline (week 0)
measure: Patients with HbA1c less than 7 percentage without any hypoglycaemic events during the previous 26 weeks (Yes or No)
timeFrame: End of study (week 26)
measure: Difference in the number of overall hypoglycaemia events within 26 weeks before and after the switch to Ryzodeg®
timeFrame: Period 1(week-26 to week 0), Period 2(week 0 to week 26)
measure: Difference in the number of severe hypoglycaemia events within 26 weeks before and after the switch to Ryzodeg®
timeFrame: Period 1(week-26 to week 0), Period 2(week 0 to week 26)
measure: Change in FPG (Fasting Plasma Glucose)
timeFrame: Period 1 (week -26 to week 0), Period 2 (week 0 to week 26)
measure: Change in daily total insulin dose
timeFrame: Period 1 (week -26 to week 0), Period 2 (week 0 to week 26)
measure: Change in daily basal insulin dose
timeFrame: Period 1 (week -26 to week 0), Period 2 (week 0 to week 26)
measure: Change in daily prandial insulin dose
timeFrame: Period 1 (week -26 to week 0), Period 2 (week 0 to week 26)
measure: Change in body weight
timeFrame: Period 1 (week -26 to week 0), Period 2 (week 0 to week 26)
Other outcomes:
Locations:
city: Daejeon
country: Korea, Republic of
facility: Novo Nordisk Investigational Site
city: Daejeon
country: Korea, Republic of
facility: Novo Nordisk Investigational Site
city: Seongnam-si
country: Korea, Republic of
facility: Novo Nordisk Investigational Site
city: Seoul
country: Korea, Republic of
facility: Novo Nordisk Investigational Site
city: Seoul
country: Korea, Republic of
facility: Novo Nordisk Investigational Site
city: Suwon-si, Gyeonggi-do
country: Korea, Republic of
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical transparency (dept. 1452)
role: STUDY_DIRECTOR
References: