UnknownPhase 3

Risk of Hypoglycemia in the Transition From Inpatient to Outpatient Setting. Comparative Study of Basal-bolus Insulin Versus Basal Insulin Plus GLP-1 Analogue

Lead sponsor

Hospital Universitario San Ignacio

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

Estimated enrollment

Study population

Type 2 diabetes

Eligibility highlights

Primary endpoint

•Documented hypoglycemia

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT05767255

Org study ID2022/145

Timeline

Milestones

Study start2022-12-01actual

Study first posted2023-03-14actual

Last update posted2023-03-14actual

Primary completion2023-08-30estimated

Study completion2023-08-30estimated

Assets

Investigational agents

Liraglutide

Who this study enrolls

Type 2 diabetes

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Patients over 18 years of age with a diagnosis of type 2 diabetes mellitus who have received basal-bolus insulin during hospitalization and who, at the time of hospital discharge, are considered necessary to continue this scheme (basal-bolus).

Exclusion criteria

•Patient with diagnosis or suspicion of DM1.

•Inability of the patient or family member to continue injectable therapy at home.

•CKD with GFR < 15 ml/minute by CKD EPI.

•History of chronic or acute pancreatitis in the last 3 months.

•History of personal or family history of medullary thyroid cancer.

•History of hypersensitivity to any of the components of the IdegLira combination.

•Women in pregnancy, breastfeeding or absence of hormonal contraception.

•Management for obesity with GLP1 receptor agonist.

•Previous management with basal bolus scheme with total daily dose of insulin (DDT) greater than 70 U/day.

•Patients with hyperglycemia associated with steroids.

•Patients who are insulin users prior to current hospitalization and have an in-hospital HbA1c greater than 11%.

Endpoints (8)

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

Glycemic / diabetes

Weight & body composition

1 endpoint

Secondary/protocol endpoint

To assess whether there is a difference in body weight

Time frame:4 weeks

Body weight, absolute change (kg)

change from baseline, improvement

Glycemic / diabetes

2 endpoints

Secondary/protocol endpoint

Compare the metrics of glycemic control

Time frame:4 weeks

CGM time-in-range

descriptive, improvement

Secondary/protocol endpoint

HbA1c change

Time frame:4 weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Safety / tolerability / PK

5 endpoints

Primary/protocol endpoint

To compare the percentage of hypoglycemia

Time frame:4 weeks

Documented hypoglycemia

threshold achievement, event

Secondary/protocol endpoint

Compare episodes of severe hypoglycemia

Time frame:4 weeks

Severe hypoglycemia

event count, event

Secondary/protocol endpoint

Compare the incidence density of hypoglycemia

Time frame:4 weeks

Documented hypoglycemia

event count, event

Secondary/protocol endpoint

compare the percentage of patients without episodes of hypoglycemia

Time frame:4 weeks

Documented hypoglycemia

threshold achievement, event

Secondary/protocol endpoint

Evaluate associated adverse effects

Time frame:4 weeks

Treatment-emergent AEs (any)

descriptive

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.

Registry references + supporting bibliography

Insulin DEgludec/LIraglutide versus multiple daily insulin injections in the transition from hospital to outpatient management assessed by continuous glucose monitoring: the DELI transition trial.
Diabetologia2025 Sep (month)PMID40760249doi:10.1007/s00125-025-06446-yvia clinicaltrials gov reference derived + pubmed nct search

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 6, 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 6, 2026 snapshot.