Diabetes Mellitus, Type 2
Conditions
Brief summary
The purpose of this study is to collect information on how Ryzodeg® works in real-world patients. Participants will get Ryzodeg® as prescribed to by their doctor. The study will last for about 5-8 months. Participants will be asked questions about their health and their diabetes treatment as part of their normal doctor's appointment
Interventions
DRUGRyzodeg®
Patients will be treated with commercially available Ryzodeg® in a prefilled device (FlexTouch®) or in a penfill according to the label and routine clinical practice at the discretion of the treating physician
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
1. Signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol). 2. The decision to initiate treatment with commercially available Ryzodeg® has been made by the patient/Legally Acceptable Representative (LAR) and the treating physician based on the approved Ryzodeg® label in China and independently from the decision to include the patient in this study. 3. Male or female, age above or equal to 18 years at the time of signing informed consent. 4. Diagnosed with T2DM and treated with any anti-hyperglycaemic medication(s) other than Ryzodeg® for at least 20 weeks prior to Treatment Initiation Visit (Visit 1). 5. Available and documented Glycosylated haemoglobin (HbA1c) value below or equal to 12 weeks prior to Informed Consent and Treatment Initiation Visit (Visit 1).
Exclusion criteria
1. Previous participation in this study. Participation is defined as having given informed consent in this study. 2. Treatment with any investigational drug within 30 days prior to enrolment into the study. 3. Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation. 4. Known or suspected hypersensitivity to the active substance or to any of the excipients as specified in the approved Ryzodeg® label in China.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Glycosylated Haemoglobin (HbA1c) | From baseline (week 0) to end of study (week 20 to 32) | Percentage point |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HbA1c less than 7 percent (Yes/No) | At the end of study (week 20 to 32) | Percentage of patients |
| HbA1c less than 7 percent without any hypoglycaemic episodes during 4 weeks prior to end of study (Yes/No) | At the end of study (week 20 to 32) Hypoglycaemic episodes occurring within 4 weeks prior to end of study (week 20 to 32). | Percentage of patients |
| Change in Fasting Plasma Glucose (FPG) | From baseline (week 0) to end of study (week 20 to 32) | mmol/L |
| Change in insulin dose (total, basal, prandial) | From baseline (week 0) to end of study (week 20 to 32) | units/day |
| Change in body weight | From baseline (week 0) to end of study (week 20 to 32) | Kg |
| Patient preference compared to previous treatment | At baseline and end of study (week 20 to 32) | Percentage of patients who prefer to continue treatment with Ryzodeg® over previous treatment. Assessed by questionnaire |
| Treatment satisfaction questionnaire (Diabetes Treatment Satisfaction Questionnaire (DTSQ)) | At baseline and end of study (week 20 to 32) | Score based on items 1, 4, 5, 6, 7 and 8. Range 0-36, where higher score means greater satisfaction (better outcome) |
Countries
China
Outcome results
None listed