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

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02754817
• Other study ID #: NN9068-4264
• Secondary ID: U1111-1176-6538
• Status: Completed
• Phase: N/A
• First received: April 27, 2016
• Last updated: January 11, 2018
• Start date: April 26, 2016
• Est. completion date: October 20, 2016

Study information

• Verified date: January 2018
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 611
• Est. completion date: October 20, 2016
• Est. primary completion date: October 20, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

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.

Locations

Country	Name	City	State
Austria	Novo Nordisk Investigational Site	Wien
Germany	Novo Nordisk Investigational Site	Leipzig
Sweden	Novo Nordisk Investigational Site	Stockholm
Switzerland	Novo Nordisk Investigational Site	St. Gallen
United Kingdom	Novo Nordisk Investigational Site	Stevenage

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

Austria,  Germany,  Sweden,  Switzerland,  United Kingdom, 

References & Publications (1)

Price H, Blüher 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, multi — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in HbA1c (Hemoglobin A1c)		week 0, week 26
Secondary	Change in HbA1c		Month 0, month 3, month 9, months 12
Secondary	Percentage of responders for HbA1c below 7 percent (53 mmol/mol)		At 3, 6, 9 and 12 months
Secondary	Percentage of responders for HbA1c below 7 percent (53 mmol/mol) with no weight gain		At 3, 6, 9 and 12 months
Secondary	Percentage of responders for HbA1c below 7 percent (53 mmol/mol) with no hypoglycaemic episodes		At 3, 6, 9 and 12 months

External Links

•   Clinical Trials at Novo Nordisk