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CompletedPhase 4

Effects of Degludec/Liraglutide on Time in Range, Inflammation and Endothelial Function vs Insulin Basal Bolus in Diabetic Inpatients

Effects of Degludec/Liraglutide on Time in Range, Markers of Inflammation and Endothelial Dysfunction Compared to Scheme Insulin Basal Bolus, in a Population of Diabetic Inpatients and Possible Correlation With Intra-hospital Mortality Rates

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

1

Recruiting sites

Enrollment

100

actual

Study population

Type 2 diabetes

Key I/E criterion

Primary endpoints

CGM time-in-rangeDocumented hypoglycemiaChange from Baseline Reactive Hyperemia Index at 3 and 9 months

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 IDNCT05360537
Org study IDU Palermo

Timeline

Milestones

Study start2021-04-01actual
Primary completion2021-12-01actual
Study completion2022-04-20actual
Study first posted2022-05-04actual
Last update posted2023-12-15actual

Assets

Investigational agents

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
Maximum age90 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

Diabetes mellitus type 2
Mild-moderate Hyperglycemia (180-400 mg/dl)
Acute events (Pneumonia, Acute cardiac Ischemia, Ictus, IVU)

Exclusion criteria

Diabetes mellitus type 1
Diabetic ketoacidosis
Hyperosmolar coma
Severe hypoglycaemia
Acute Pancreatitis
Cancer
use of corticosteroids
pregnancy
Chronic kidney disease (< 30 ml/min) or hemodialysis

Endpoints (7)

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

Other (unclassified)
3
Cardiovascular outcomes
1
Glycemic / diabetes
1
Cardiometabolic biomarkers
1
Safety / tolerability / PK
1

Cardiovascular outcomes

1 endpoint
Secondary/protocol endpoint

Change of intra and extra-hospital mortality

Time frame:7 days, 1 months and 6 months

All-cause death

change from baseline, event

SNOMED 419620001

Glycemic / diabetes

1 endpoint
Primary/protocol endpoint

Change of Time in Range % at 7 days, at 1 and 6 months

Time frame:7 days, 1 months and 6 months

CGM time-in-range

change from baseline, improvement

Cardiometabolic biomarkers

1 endpoint
Secondary/protocol endpoint

Change from Baseline serum of C- Reactive-Protein (CRP)

Time frame:7 days, 1 months and 6 months

hs-CRP, change

change from baseline, improvement

LOINC 30522-7

Safety / tolerability / PK

1 endpoint
Primary/protocol endpoint

Change of hypoglycemic events

Time frame:7 days, 1 months and 6 months

Documented hypoglycemia

event count, event

Other (unclassified)

3 endpoints
Primary/protocol endpoint/low confidence

Change from Baseline Reactive Hyperemia Index at 3 and 9 months

Time frame:7 days, 1 months and 6 months

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change from Baseline serum levels of Interleukin-6 (IL6)

Time frame:7 days, 1 months and 6 months

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change from Baseline serum levels of ferritin

Time frame:7 days, 1 months and 6 months

change from baseline, descriptive

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.