A Study of the Effectiveness of Xultophy® (Insulin Degludec/Liraglutide) in an Adult Real-world Population With Type 2 Diabetes Mellitus

Novo Nordisk

Status: Completed

Conditions: Diabetes; Diabetes Mellitus, Type 2

Treatments: Drug: insulin degludec/liraglutide

Study type: Observational

Funder types: Industry

Identifiers

NCT02754817

U1111-1176-6538 (Other Identifier)

NN9068-4264

Details and patient eligibility

About

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.

Enrollment: 611 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

611 participants in 1 patient group

Insulin degludec/liraglutide

Treatment:

Drug: insulin degludec/liraglutide