The purpose of the study is to collect information on how Ryzodeg® works in real world participants. Participants will get Ryzodeg® as prescribed to them by the study doctor. The study will last for about 6 to 8 months. The participants will be asked questions about their health and their diabetes treatment as part of their normal study doctor's appointment.
Study Type
OBSERVATIONAL
Enrollment
246
Patients will be treated with commercially available Insulin Degludec/Insulin Aspart (Ryzodeg®) in a pre-filled pen injector (FlexTouch®) according to routine clinical practice at the discretion of the treating physician in accordance with the Ryzodeg® label in Japan
Change in local laboratory measured glycosylated haemoglobin (HbA1c)
Measured in %point
Time frame: From baseline (up to 12 weeks prior to treatment initiation (week 0)) to end of study visit or at discontunuation (-2 to +8 weeks at 26 weeks)
Change in total insulin dose
Measured in units/day
Time frame: From baseline (the most recent dose prior to treatment initiation (week 0)) to end of study visit or at discontinuation (-2 to +8 weeks at 26 weeks)
Change in basal insulin dose
Measured in units/day
Time frame: From baseline (the most recent dose prior to treatment initiation (week 0)) to end of study visit or at discontinuation (-2 to +8 weeks at 26 weeks)
Change in prandial insulin dose
Measured in units/day
Time frame: From baseline (the most recent dose prior to treatment initiation (week 0)) to end of study visit or at discontinuation (-2 to +8 weeks at 26 weeks)
Change in local laboratory measured fasting plasma glucose (FPG)
Measured in mg/dL
Time frame: From baseline (up to 12 weeks prior to treatment initiation (week 0)) to end of study (-2 to +8 weeks at 26 weeks)
The incidence of patient recollection of non-severe hypoglycaemic episodes
Measured in episodes/person-year
Time frame: Pre- and post initiation of treatment with Ryzodeg®. Episodes occurring within 4 weeks prior to initiation of treatment with Ryzodeg® and within 4 weeks prior to end of study visit or at discontinuation (-2 to +8 weeks at 26 weeks)
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Novo Nordisk Investigational Site
Arakawa-ku, Tokyo, Japan
Novo Nordisk Investigational Site
Chuo-ku, Tokyo, Japan
Novo Nordisk Investigational Site
Fukuoka-shi, Fukuoka, Japan
Novo Nordisk Investigational Site
Fukushima, Japan
Novo Nordisk Investigational Site
Higashiosaka-shi, Osaka, Japan
Novo Nordisk Investigational Site
Hokkaido, Japan
Novo Nordisk Investigational Site
Hosu-gun, Ishikawa, Japan
Novo Nordisk Investigational Site
Kanagawa, Japan
Novo Nordisk Investigational Site
Kanagawa, Japan
Novo Nordisk Investigational Site
Kawagoe-shi, Saitama, Japan
...and 19 more locations
The incidence of patient recollection of nocturnal non-severe hypoglycaemic episodes
Measured in episodes/person-year
Time frame: Pre- and post initiation of treatment with Ryzodeg®. Episodes occurring within 4 weeks prior to initiation of treatment with Ryzodeg® and within 4 weeks prior to end of study visit or at discontinuation (-2 to +8 weeks at 26 weeks)
The incidence of patient recollection of overall severe hypoglycaemic episodes
Measured in episodes/person-year
Time frame: Pre- and post initiation of treatment with Ryzodeg®. Episodes occurring within 26 weeks prior to initiation of treatment with Ryzodeg® and within 26 weeks prior to end of study visit or at discontinuation (-2 to +8 weeks at 26 weeks)
The incidence of patient recollection of nocturnal severe hypoglycaemic episodes
Measured in episodes/person-year
Time frame: Pre- and post initiation of treatment with Ryzodeg®. Episodes occurring within 26 weeks prior to initiation of treatment with Ryzodeg® and within 26 weeks prior to end of study visit or at discontinuation (-2 to +8 weeks at 26 weeks)
Change in selected patient reported outcomes: Diabetes Therapy Related Quality of Life (DTR-QoL)
Score (on a scale from 0-100, where 100 is the highest health related quality of life (HRQoL))
Time frame: From baseline to end of study visit or at discontinuation (-2 to +8 weeks at 26 weeks). Baseline defined as visit 1 (week 0)