Diabetes Mellitus, Type 2
Conditions
Brief summary
The purpose of the study is to collect information on how Xultophy® works in patients with type 2 diabetes. The participants will get Xultophy® as prescribed to them by the study doctor. The study will last for about 26-34 weeks. The participants will be asked questions about their health and their diabetes treatment as part of their normal study doctor's appointment.
Interventions
DRUGInsulin degludec/liraglutide
Patients will be treated with Insulin degludec/liraglutide (Xultophy®) at the treating physician's discretion and independent from the decision to include the patient in the 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
* Signed informed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol). * The decision to initiate treatment with commercially available Xultophy® has been made by the patient/Legally Acceptable Representative and the treating physician before and independently from the decision to include the patient in this study. * Male or female, age greater than or equal to 18 years at the time of signing informed consent. * Diagnosed with type 2 diabetes and treated with basal insulin plus or minus oral anti-diabetic drugs (OADs) or Glucagon-Like Peptide-1 Receptor Agonist (GLP-1 RA) plus or minus OADs, except Xultophy®, for at least 12 weeks prior to informed consent and initiation visit (visit 1). * Available and documented glycosylated haemoglobin A1c (HbA1c) value less than or equal to 12 weeks prior to initiation of Xultophy® treatment.
Exclusion criteria
* Hypersensitivity to the active substance or to any of the excipients as specified in the Xultophy® local label. * Previous participation in this study. Participation is defined as having given informed consent in this study. * Female who is known pregnant, breast-feeding or intends to become pregnant. * Treated with Xultophy® previously. * Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in laboratory measured glycosylated haemoglobin A1c (HbA1c) | From baseline [≤12 weeks prior to treatment initiation [week 0]) to end of study (26-34 weeks) | Measured in % point |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in laboratory measured fasting plasma glucose (FPG) | From baseline [≤12 weeks prior to treatment initiation [week 0]) to end of study (26-34 weeks) | Measured in mg/dL |
| Average dose step of Xultophy® at end of the study | At the end of study (26-34 weeks) | Measured in dose steps/day |
| Change of body weight | From baseline [≤12 weeks prior to treatment initiation [week 0]) to end of study (26-34 weeks) | Measured in kg |
| Patients reached HbA1c less than 7% at end of study (Yes/No ) | At the end of study visit (26-34 weeks) | Number of patients who achieved/not achieved HbA1c at end of study: \<7.0% |
| Change in number of patient self-reported nocturnal non-severe hypoglycaemic episodes based on recollection | Pre- to post- initiation of treatment with Xultophy®. Episodes occurring within 4 weeks prior to initiation of treatment with Xultophy® and to within 4 weeks prior to end of study (26-34 weeks) | Number of episodes |
| Change in number of patient self-reported severe hypoglycaemic episodes based on recollection (overall) | Pre- to post- initiation of treatment with Xultophy®. Episodes occurring within 26 weeks prior to initiation of treatment with Xultophy® and to within 26 weeks prior to end of study (26-34 weeks) | Number of episodes |
| Reason(s) for discontinuing treatment with Xultophy® during the treatment period, if applicable | At the end of study (26-34 weeks) | Pre-specified response option(s) |
| Change in number of patient self-reported overall non-severe hypoglycaemic episodes based on recollection | Pre- to post- initiation of treatment with Xultophy®. Episodes occurring within 4 weeks prior to initiation of treatment with Xultophy® and to within 4 weeks prior to end of study (26-34 weeks) | Number of episodes |
Countries
United Arab Emirates
Outcome results
None listed