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

NCT ID: NCT02754817

Last Updated: 2018-01-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

611 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-04-26

Study Completion Date

2016-10-20

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetes Diabetes Mellitus, Type 2

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Insulin degludec/liraglutide

insulin degludec/liraglutide

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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
* Mental incapacity, unwillingness or inability to provide informed consent, or language barriers precluding adequate understanding or co-operation
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Global Clinical Registry (GCR, 1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

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Novo Nordisk Investigational Site

Vienna, , Austria

Site Status

Novo Nordisk Investigational Site

Leipzig, , Germany

Site Status

Novo Nordisk Investigational Site

Stockholm, , Sweden

Site Status

Novo Nordisk Investigational Site

Sankt Gallen, , Switzerland

Site Status

Novo Nordisk Investigational Site

Stevenage, , United Kingdom

Site Status

Countries

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Austria Germany Sweden Switzerland United Kingdom

References

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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.

Reference Type RESULT
PMID: 29205856 (View on PubMed)

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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U1111-1176-6538

Identifier Type: OTHER

Identifier Source: secondary_id

NN9068-4264

Identifier Type: -

Identifier Source: org_study_id

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