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

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

Lead sponsor

Novo Nordisk A/S

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

5

Recruiting sites

Enrollment

611

actual

Study population

Type 2 diabetes

Key I/E criterion

Primary endpoint

HbA1c, change

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT02754817
Org study IDNN9068-4264
Secondary IDU1111-1176-6538WHO

Timeline

Milestones

Study start2016-04-26actual
Study first posted2016-04-28estimated
Primary completion2016-10-20actual
Study completion2016-10-20actual
Last update posted2018-01-12actual

Assets

Investigational agents

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted
Sampling methodNon probability sample

Study population text

This study will include adults with T2DM. Collecting data reported in medical records of patients with T2DM who received their first prescription of Xultophy® at least 6 months prior to inclusion in this study, no matter whether Xultophy® was continued afterwards.

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

Endpoints (5)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Glycemic / diabetes

5 endpoints
Primary/protocol endpoint

Change in HbA1c (Hemoglobin A1c)

Time frame:week 0, week 26

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change in HbA1c

Time frame:Month 0, month 3, month 9, months 12

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Percentage of responders for HbA1c below 7 percent (53 mmol/mol)

Time frame:At 3, 6, 9 and 12 months

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Percentage of responders for HbA1c below 7 percent (53 mmol/mol) with no weight gain

Time frame:At 3, 6, 9 and 12 months

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Percentage of responders for HbA1c below 7 percent (53 mmol/mol) with no hypoglycaemic episodes

Time frame:At 3, 6, 9 and 12 months

HbA1c <7.0% achievement

threshold achievement, improvement

componentsHbA1c <7.0% achievement, Documented hypoglycemia

LOINC 4548-4

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.