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

Sponsor

Novo Nordisk A/S (Industry)

Overall Status

Completed

CT.gov ID

NCT02754817

Collaborator

(none)

611

Enrollment

Locations

5.8

Actual Duration (Months)

122.2

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Diabetes Mellitus, Type 2	Drug: insulin degludec/liraglutide

Study Design

Study Type:

Observational

Actual Enrollment :

611 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

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

Actual Study Start Date :

Apr 26, 2016

Actual Primary Completion Date :

Oct 20, 2016

Actual Study Completion Date :

Oct 20, 2016

Arms and Interventions

Arm	Intervention/Treatment
Insulin degludec/liraglutide	Drug: insulin 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.

Arm

Intervention/Treatment

Insulin degludec/liraglutide

Drug: insulin 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.

Outcome Measures

Primary Outcome Measures

Change in HbA1c (Hemoglobin A1c) [week 0, week 26]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Novo Nordisk Investigational Site	Wien	Austria	1130
2	Novo Nordisk Investigational Site	Leipzig	Germany	04103
3	Novo Nordisk Investigational Site	Stockholm	Sweden	111 57
4	Novo Nordisk Investigational Site	St. Gallen	Switzerland	9016
5	Novo Nordisk Investigational Site	Stevenage	United Kingdom	SG1 4AB