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

NCT05767255 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2023-03-14

No results posted yet for this study

Summary

The association of insulin degludec with liraglutide in the same device (IDegLira) is a potent but at the same time safe drug that reduces the risk of hypoglycemia when compared to a basal or basal-bolus insulin schedule.

The DUAL (Dual Action of Liraglutide and Insulin Degludec) studies are the pivotal studies of this combination. Specifically, the DUAL VII study has demonstrated that ideglira is a non-inferior drug in terms of glycemic control versus a basal-bolus schedule in patients in the outpatient setting who have failed basal insulin.

Although the basal-bolus insulin plus correction schedule is frequently used in hospitalized patients with hyperglycemia, outpatient management with a complex insulin schedule creates challenges that are difficult to mitigate due to limited time for patient education during an acute illness and limited access to the physician responsible for post-discharge diabetes management.

The use of IDegLira has not been evaluated in clinical studies in the hospital discharge setting where the authors believe it has great potential because it offers similar potency to the basal-bolus scheme but with greater safety with respect to hypoglycemia and less complexity for the patient because it is associated with fewer applications and less need for capillary self-monitoring.

For this reason, in the hospital-home transition scenario, ideglira therapy in patients with poor metabolic control and requiring intensification therapy is proposed as an alternative to the basal-bolus scheme.

Conditions

  • Diabetes Mellitus, Type 2 Treated With Insulin

Interventions

DRUG

insulin degludec + liraglutide

The association of insulin degludec with liraglutide in the same device (IDegLira) is a potent and safe drug that reduces the risk of hypoglycemia.

DRUG

Insulin Glargine - Insulin Aspart

The insulin dose of the basal group will be adjusted according to the blood glucose reports presented by the patients.

Sponsors & Collaborators

  • Hospital Universitario San Ignacio

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-01
Primary Completion
2023-08-30
Completion
2023-08-30
FDA Drug
Yes

Countries

  • Colombia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05767255 on ClinicalTrials.gov