Diabetes, Diabetes Mellitus, Type 2
Conditions
Brief summary
This study is conducted in Europe. The aim of the study is to investigate the effectiveness of Xultophy® (insulin degludec/liraglutide) in an adult real-world population with type 2 diabetes mellitus.
Interventions
DRUGinsulin degludec/liraglutide
This is a non-interventional, chart review study and the patients are treated according to current clinical practice and local licenses upon the treating physicians' decision.
Sponsors
Novo Nordisk A/S
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
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 extraction of data according to the protocol) * Male or female patients at least 18 years of age at time of informed consent * Diagnosis of T2DM (type 2 diabetes mellitus) * Xultophy® initiation prescribed at least 6 months before inclusion in this study (i.e., date of signed informed consent). Patients may or may not be continuing Xultophy® at study inclusion * Minimum available data:a.) At the time of Xultophy® prescription: HbA1c value (or if unavailable, the most recent HbA1c value within 6 months before the first Xultophy® prescription);b.) At 6 months plus/minus 45 days after first Xultophy® prescription: HbA1c value
Exclusion criteria
* Type 1 diabetes * Previous participation in this study. Participation is defined as having provided informed consent * Participation in a clinical trial within 6 months before or 12 months after the first Xultophy® prescription (Participation in a non-interventional study is not an
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in HbA1c (Hemoglobin A1c) | week 0, week 26 |
Secondary
| Measure | Time frame |
|---|---|
| Change in HbA1c | Month 0, month 3, month 9, months 12 |
| Percentage of responders for HbA1c below 7 percent (53 mmol/mol) | At 3, 6, 9 and 12 months |
| Percentage of responders for HbA1c below 7 percent (53 mmol/mol) with no weight gain | At 3, 6, 9 and 12 months |
| Percentage of responders for HbA1c below 7 percent (53 mmol/mol) with no hypoglycaemic episodes | At 3, 6, 9 and 12 months |
Countries
Austria, Germany, Sweden, Switzerland, United Kingdom
Outcome results
None listed