DelfaGLP-1 Atlas

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INTENSIFY

Completed

A Research Study, Looking at How Xultophy® Works in People With Type 2 Diabetes in Local Clinical Practice in United Arab Emirates

A Multicenter Prospective Non-interventional Study Investigating the Treatment Effect of Xultophy® Intensification in a Real World Population With Type 2 Diabetes in United Arab Emirates

Lead sponsor

Novo Nordisk A/S

Assets

GLP-1 / incretin class catch-all / Liraglutide

Listed sites

3

Recruiting sites

—

Enrollment

300

actual

Study population

Type 2 diabetes

Key I/E criterion

•HbA1c ≤12%

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 IDNCT03823339
Org study IDNN9068-4458
Secondary IDU1111-1213-4338World Health Organization (WHO)

Timeline

Milestones

Study start2019-01-29actual
Study first posted2019-01-30actual
Primary completion2020-12-14actual
Study completion2020-12-14actual
Last update posted2021-09-22actual

Assets

Investigational agents

GLP-1 / incretin class catch-allLiraglutide

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

Subjects with Type 2 Diabetes

Inclusion criteria

•Signed informed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol).
•The decision to initiate treatment with commercially available Xultophy® has been made by the patient/Legally Acceptable Representative and the treating physician before and independently from the decision to include the patient in this study.
•Male or female, age greater than or equal to 18 years at the time of signing informed consent.
•Diagnosed with type 2 diabetes and treated with basal insulin plus or minus oral anti-diabetic drugs (OADs) or Glucagon-Like Peptide-1 Receptor Agonist (GLP-1 RA) plus or minus OADs, except Xultophy®, for at least 12 weeks prior to informed consent and initiation visit (visit 1).
•Available and documented glycosylated haemoglobin A1c (HbA1c) value less than or equal to 12 weeks prior to initiation of Xultophy® treatment.

Exclusion criteria

•Hypersensitivity to the active substance or to any of the excipients as specified in the Xultophy® local label.
•Previous participation in this study. Participation is defined as having given informed consent in this study.
•Female who is known pregnant, breast-feeding or intends to become pregnant.
•Treated with Xultophy® previously.
•Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.

Endpoints (9)

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.

Coverage by outcome category

Safety / tolerability / PK
4
Glycemic / diabetes
3
Weight & body composition
1
Other (unclassified)
1

Weight & body composition

1 endpoint
Secondary/protocol endpoint

Change of body weight

Time frame:From baseline [≤12 weeks prior to treatment initiation [week 0]) to end of study (26-34 weeks)

Body weight, absolute change (kg)

change from baseline, improvement

Glycemic / diabetes

3 endpoints
Primary/protocol endpoint

Change in laboratory measured glycosylated haemoglobin A1c (HbA1c)

Time frame:From baseline [≤12 weeks prior to treatment initiation [week 0]) to end of study (26-34 weeks)

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Patients reached HbA1c less than 7% at end of study (Yes/No )

Time frame:At the end of study visit (26-34 weeks)

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change in laboratory measured fasting plasma glucose (FPG)

Time frame:From baseline [≤12 weeks prior to treatment initiation [week 0]) to end of study (26-34 weeks)

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Safety / tolerability / PK

4 endpoints
Secondary/protocol endpoint

Change in number of patient self-reported overall non-severe hypoglycaemic episodes based on recollection

Time frame:Pre- to post- initiation of treatment with Xultophy®. Episodes occurring within 4 weeks prior to initiation of treatment with Xultophy® and to within 4 weeks prior to end of study (26-34 weeks)

change from baseline, event

Secondary/protocol endpoint

Change in number of patient self-reported nocturnal non-severe hypoglycaemic episodes based on recollection

Time frame:Pre- to post- initiation of treatment with Xultophy®. Episodes occurring within 4 weeks prior to initiation of treatment with Xultophy® and to within 4 weeks prior to end of study (26-34 weeks)

Documented hypoglycemia

event count, event

Secondary/protocol endpoint

Change in number of patient self-reported severe hypoglycaemic episodes based on recollection (overall)

Time frame:Pre- to post- initiation of treatment with Xultophy®. Episodes occurring within 26 weeks prior to initiation of treatment with Xultophy® and to within 26 weeks prior to end of study (26-34 weeks)

Severe hypoglycemia

event count, event

Secondary/protocol endpoint

Reason(s) for discontinuing treatment with Xultophy® during the treatment period, if applicable

Time frame:At the end of study (26-34 weeks)

Discontinuation due to AE

descriptive, event

Other (unclassified)

1 endpoint
Secondary/protocol endpoint/low confidence

Average dose step of Xultophy® at end of the study

Time frame:At the end of study (26-34 weeks)

descriptive

Publications (10)

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.

Registry references + supporting bibliography

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.