An observational study in Diabetes Mellitus, Type 2, sponsored by Novo Nordisk A/S. Completed at 29 sites in Japan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2019-12-09.
Sponsored by Novo Nordisk A/S · Observational
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.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 246 is close to the median of 233 across 2,220 observational studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Novo Nordisk A/S is the lead sponsor of 1,370 studies on the registry; 102 are open to participants now.
Of its 198 completed or terminated interventional studies of FDA-regulated products, 94 (47%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients with type 2 diabetes requiring insulin therapy
Exclusion Criteria:
Patients with type 2 diabetes requiring insulin therapy in Japanese routine clinical practice previously treated with insulin glargine (IGlar)
Drug: Insulin Degludec/Insulin Aspart
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)
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)
Plan to share: Yes — According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
This study is completed, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.
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Novo Nordisk A/S