Diabetes Mellitus, Type 2
Conditions
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.
Interventions
DRUGRyzodeg®
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.
Sponsors
Novo Nordisk A/S
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
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®
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in HbA1c (Glycosylated Hemoglobin) | Period 1 (week -26 to week 0), Period 2 (week 0 to week 26) | Percentage point |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patients with HbA1c less than 7 percentage without any hypoglycaemic events during the previous 26 weeks (Yes or No) | At baseline (week 0) | Percentage of patients |
| 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 |
| Change in FPG (Fasting Plasma Glucose) | Period 1 (week -26 to week 0), Period 2 (week 0 to week 26) | mmol/L |
| Patients with HbA1c less than 7.0 percentage (Yes or No) | At baseline (week 0) | Percentage of patients |
| Change in daily basal insulin dose | Period 1 (week -26 to week 0), Period 2 (week 0 to week 26) | Unit/day |
| 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 |
| Change in daily total insulin dose | Period 1 (week -26 to week 0), Period 2 (week 0 to week 26) | Unit/day |
Countries
South Korea
Outcome results
None listed