An observational study in Diabetes Mellitus, Type 2, sponsored by Novo Nordisk A/S. Completed at 64 sites in 6 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by Novo Nordisk A/S · Observational
The purpose of the study is to collect information on how Ryzodeg® works in real world patients and to see if Ryzodeg® can lower blood sugar levels. Participants will get Ryzodeg® as prescribed to them by their doctor. The study will last for about 6 to 9 months. Participants will be asked questions about their health and their diabetes treatment as part of their normal doctor's appointment.
10,926 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 1,122 is above 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; 101 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.
Real-world population of type 2 patients, who have been initiated or switched to Ryzodeg® from previous antihyperglycaemic treatment according to local clinical practice
Exclusion Criteria:
Real-world population of patients with Diabetes Mellitus, Type 2 (T2DM), who have been initiated or switched to Ryzodeg® from previous antihyperglycaemic treatment according to local clinical practice.
Drug: Insulin Degludec/Insulin Aspart
Insulin Degludec/Insulin Aspart (Ryzodeg®) as prescribed by the patient's treating physician. The decision to initiate or switch into treatment with commercially available Ryzodeg® has been made before, and independently from, the decision to include the patient in this study.
Change in local laboratory measured glycosylated haemoglobin (HbA1c)
Percentage point
Time frame: From baseline (week 0) to end of study (week 26-36)
HbA1c less than 7% (Yes/No)
Percentage of patients
Time frame: At the end of study (week 26-36)
HbA1c less than pre-defined individual treatment target (Yes/No)
Percentage of patients
Time frame: At the end of study (week 26-36)
Change in local laboratory measured fasting plasma glucose (FPG)
mg/dL
Time frame: From baseline (week 0) to end of study (week 26-36)
Change in local laboratory measured FPG
mmol/L
Time frame: From baseline (week 0) to end of study (week 26-36)
Change in insulin dose (total, basal, prandial)
units/day
Time frame: From baseline (week 0) to end of study (week 26-36)
Change in body weight
Kg
Time frame: From baseline (week 0) to end of study (week 26-36)
Number of patient recollection of non-severe hypoglycaemic episodes
Number of episodes
Time frame: At baseline (week 0). Episodes occurring within 4 weeks prior to initiation of treatment with Ryzodeg®
Number of patient recollection of non-severe hypoglycaemic episodes
Number of episodes
Time frame: At the end of study (week 26-36). Episodes occurring within 4 weeks prior to end of study
Number of patient recollection of nocturnal non-severe hypoglycaemic episodes
Number of episodes
Time frame: At baseline (week 0). Episodes occurring within 4 weeks prior to initiation of treatment with Ryzodeg®
Number of patient recollection of nocturnal non-severe hypoglycaemic episodes
Number of episodes
Time frame: At end of study (week 26-36). Episodes occurring within 4 weeks prior to end of study
Number of patient recollection of overall severe hypoglycaemic episodes
Number of episodes
Time frame: At baseline (week 0). Episodes occurring within 26 weeks prior to initiation of treatment with Ryzodeg®
Number of patient recollection of overall severe hypoglycaemic episodes
Number of episodes
Time frame: At the end of study (week 26-36). Episodes occurring within 26 weeks prior to end of study
Number of weekly self-measured plasma glucose (SMPG) measurements
Number of measurements
Time frame: At baseline (week 0). Measurements occurring within 7 days prior to initiation of treatment with Ryzodeg®
Number of weekly self-measured plasma glucose (SMPG) measurements
Number of measurements
Time frame: At end of study (week 26-36). Measurements occurring within 7 days prior to end of study
Reason for initiating Ryzodeg® (pre-specified response option(s))
Percentage of patients per response option
Time frame: At baseline (week 0)
Discontinue treatment with Ryzodeg® during the treatment period (Yes/No)
Percentage of patients
Time frame: At treatment discontinuation (week 0-36) or at end of study (week 26-36). After initiation of treatment with Ryzodeg® until treatment discontinuation
Reason for discontinuing treatment with Ryzodeg® during the treatment period, if applicable, (pre-specified response option(s))
Percentage of patients per response option
Time frame: At treatment discontinuation (week 0-36). After initiation of treatment with Ryzodeg® until treatment discontinuation
Time period from initiation to discontinuation of treatment with Ryzodeg®
Days
Time frame: At treatment discontinuation (week 0-36). After initiation of treatment with Ryzodeg® until treatment discontinuation
Plan to share: Yes — According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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Novo Nordisk A/S