Diabetes Mellitus, Type 2
Conditions
Brief summary
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.
Interventions
DRUGInsulin 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.
Sponsors
Novo Nordisk A/S
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Informed consent obtained before any study-related activities. Study-related activities are any procedures related to recording of data according to the protocol. * The decision to initiate or switch into treatment with commercially available Ryzodeg® has been made by the patient/Legally Acceptable Representative (LAR) and the treating physician based on local label before, and independently from, the decision to include the patient in this study. * Male or female, age above or equal to 18 years at the time of signing informed consent. * Diagnosed with T2DM and treated with any anti-hyperglycaemic medication(s) other than Ryzodeg® for at least 26 weeks prior to signing informed consent. * Available and documented HbA1c value for 12 weeks or less prior to signing informed consent.
Exclusion criteria
* Hypersensitivity to the active substance or to any of the excipients as specified in the Ryzodeg® local label. * Previous participation in this study. Participation is defined as signed informed consent. * Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation. * Previous treatment with Ryzodeg®.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in local laboratory measured glycosylated haemoglobin (HbA1c) | From baseline (week 0) to end of study (week 26-36) | Percentage point |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HbA1c less than pre-defined individual treatment target (Yes/No) | At the end of study (week 26-36) | Percentage of patients |
| Change in local laboratory measured fasting plasma glucose (FPG) | From baseline (week 0) to end of study (week 26-36) | mg/dL |
| Change in local laboratory measured FPG | From baseline (week 0) to end of study (week 26-36) | mmol/L |
| Change in insulin dose (total, basal, prandial) | From baseline (week 0) to end of study (week 26-36) | units/day |
| Change in body weight | From baseline (week 0) to end of study (week 26-36) | Kg |
| Number of patient recollection of non-severe hypoglycaemic episodes | At baseline (week 0). Episodes occurring within 4 weeks prior to initiation of treatment with Ryzodeg® | Number of episodes |
| HbA1c less than 7% (Yes/No) | At the end of study (week 26-36) | Percentage of patients |
| Number of patient recollection of overall severe hypoglycaemic episodes | At baseline (week 0). Episodes occurring within 26 weeks prior to initiation of treatment with Ryzodeg® | Number of episodes |
| Number of weekly self-measured plasma glucose (SMPG) measurements | At baseline (week 0). Measurements occurring within 7 days prior to initiation of treatment with Ryzodeg® | Number of measurements |
| Reason for initiating Ryzodeg® (pre-specified response option(s)) | At baseline (week 0) | Percentage of patients per response option |
| Discontinue treatment with Ryzodeg® during the treatment period (Yes/No) | At treatment discontinuation (week 0-36) or at end of study (week 26-36). After initiation of treatment with Ryzodeg® until treatment discontinuation | Percentage of patients |
| Reason for discontinuing treatment with Ryzodeg® during the treatment period, if applicable, (pre-specified response option(s)) | At treatment discontinuation (week 0-36). After initiation of treatment with Ryzodeg® until treatment discontinuation | Percentage of patients per response option |
| Time period from initiation to discontinuation of treatment with Ryzodeg® | At treatment discontinuation (week 0-36). After initiation of treatment with Ryzodeg® until treatment discontinuation | Days |
| Number of patient recollection of nocturnal non-severe hypoglycaemic episodes | At baseline (week 0). Episodes occurring within 4 weeks prior to initiation of treatment with Ryzodeg® | Number of episodes |
Countries
Australia, India, Malaysia, Philippines, Saudi Arabia, South Africa
Outcome results
None listed