Clinical trial NCT02754817: A Study of the Effectiveness of Xultophy® (Insulin Degludec/Liraglutide) in an Adult Real-world Population With Type 2 Diabetes Mellitus
Official title: A European Multi-centre, Retrospective, Non-interventional Study of the Effectiveness of Xultophy® (Insulin Degludec/Liraglutide) in an Adult Real-world Population With Type 2 Diabetes Mellitus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2016-04-28
Enrollment: 611
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study will include adults with T2DM. Collecting data reported in medical records of patients with T2DM who received their first prescription of Xultophy® at least 6 months prior to inclusion in this study, no matter whether Xultophy® was continued afterwards.

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.


Eligibility criteria: 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 exclusion criteria)
* Mental incapacity, unwillingness or inability to provide informed consent, or language barriers precluding adequate understanding or co-operation

Primary outcomes:
measure: Change in HbA1c (Hemoglobin A1c)
timeFrame: week 0, week 26
Secondary outcomes:
measure: Change in HbA1c
timeFrame: Month 0, month 3, month 9, months 12
measure: Percentage of responders for HbA1c below 7 percent (53 mmol/mol)
timeFrame: At 3, 6, 9 and 12 months
measure: Percentage of responders for HbA1c below 7 percent (53 mmol/mol) with no weight gain
timeFrame: At 3, 6, 9 and 12 months
measure: Percentage of responders for HbA1c below 7 percent (53 mmol/mol) with no hypoglycaemic episodes
timeFrame: At 3, 6, 9 and 12 months
Other outcomes:
Locations:
city: Wien
country: Austria
facility: Novo Nordisk Investigational Site
city: Leipzig
country: Germany
facility: Novo Nordisk Investigational Site
city: Stockholm
country: Sweden
facility: Novo Nordisk Investigational Site
city: St. Gallen
country: Switzerland
facility: Novo Nordisk Investigational Site
city: Stevenage
country: United Kingdom
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Price H, Bluher M, Prager R, Phan TM, Thorsted BL, Schultes B; EXTRA study group. Use and effectiveness of a fixed-ratio combination of insulin degludec/liraglutide (IDegLira) in a real-world population with type 2 diabetes: Results from a European, multicentre, retrospective chart review study. Diabetes Obes Metab. 2018 Apr;20(4):954-962. doi: 10.1111/dom.13182. Epub 2018 Jan 11.