A Research Study, Looking at How Ryzodeg® (Insulin Degludec/Insulin Aspart) Works in People With Type 2 Diabetes in Local Clinical Practice
- Registration Number
- NCT04042441
- Lead Sponsor
- Novo Nordisk A/S
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1122
- 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.
- 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®.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Ryzodeg® as per local practice Insulin Degludec/Insulin Aspart 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.
- Primary Outcome Measures
Name Time Method Change in local laboratory measured glycosylated haemoglobin (HbA1c) From baseline (week 0) to end of study (week 26-36) Percentage point
- Secondary Outcome Measures
Name Time Method HbA1c less than 7% (Yes/No) At the end of study (week 26-36) Percentage of patients
HbA1c less than pre-defined individual treatment target (Yes/No) At the end of study (week 26-36) Percentage of patients
Change in insulin dose (total, basal, prandial) From baseline (week 0) to end of study (week 26-36) units/day
Number of patient recollection of overall severe hypoglycaemic episodes At the end of study (week 26-36). Episodes occurring within 26 weeks prior to end of study Number of episodes
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
Change in local laboratory measured FPG From baseline (week 0) to end of study (week 26-36) mmol/L
Number of patient recollection of nocturnal non-severe hypoglycaemic episodes At end of study (week 26-36). Episodes occurring within 4 weeks prior to end of study Number of episodes
Reason for initiating Ryzodeg® (pre-specified response option(s)) At baseline (week 0) 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
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 the end of study (week 26-36). Episodes occurring within 4 weeks prior to end of study Number of episodes
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
Number of weekly self-measured plasma glucose (SMPG) measurements At end of study (week 26-36). Measurements occurring within 7 days prior to end of study Number of measurements
Change in local laboratory measured fasting plasma glucose (FPG) From baseline (week 0) to end of study (week 26-36) mg/dL
Trial Locations
- Locations (64)
Royal North Shore Hospital
🇦🇺St Leonards, New South Wales, Australia
Illawarra Diabetes Service Clinical Trials & Research Unit
🇦🇺Wollongong, New South Wales, Australia
Royal Brisbane and Women's Hospital
🇦🇺Herston, Queensland, Australia
Mater Hospital Brisbane
🇦🇺South Brisbane, Queensland, Australia
Lyell McEwin Hospital
🇦🇺Elizabeth Vale, South Australia, Australia
South Australian Endocrine Research
🇦🇺Keswick, South Australia, Australia
Hobart Cardiology
🇦🇺Hobart, Tasmania, Australia
Box Hill Specialist Consulting rooms
🇦🇺Box Hill, Victoria, Australia
Baker IDI Heart and Diabetes Institute
🇦🇺Melbourne, Victoria, Australia
Rockingham General Hospital
🇦🇺Cooloongup, Western Australia, Australia
Scroll for more (54 remaining)Royal North Shore Hospital🇦🇺St Leonards, New South Wales, Australia