Overview

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

Status:
Completed
Trial end date:
2016-10-20
Target enrollment:
0
Participant gender:
All
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.
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Novo Nordisk A/S
Treatments:
Insulin
Insulin, Globin Zinc
Insulin, Long-Acting
Liraglutide
Xultophy
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