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 | Unknown Phase 3 FDA Drug

• 1 other identifier: 2022/145
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

IDegLira; Type 2 diabetes mellitus; Glycemic; Diabetes medications.

Outcome Measures

Primary Outcomes (1)

• To compare the percentage of hypoglycemia

  To compare the percentage of patients presenting at least one episode of hypoglycemia (defined as one or more episodes of hypoglycemia below 54 mg/ dL for more than 20 minutes by continuous flash glucose monitoring), between the basal bolus group and the degludec/liraglutide (ideglira) group in the first four weeks after hospital discharge.

  4 weeks

Secondary Outcomes (7)

• Compare episodes of severe hypoglycemia

  4 weeks

• Compare the metrics of glycemic control

  4 weeks

• Compare the incidence density of hypoglycemia

  4 weeks

• compare the percentage of patients without episodes of hypoglycemia

  4 weeks

• HbA1c change

  4 weeks

Study Arms (2)

basal group bolus

ACTIVE COMPARATOR

* Insulin Glargine required on an in-hospital basis * Insulin Aspart required on an in-hospital basis

Drug: Insulin Glargine - Insulin Aspart

insulin degludec + liraglutide ( ideglira)

EXPERIMENTAL

16 Units once a day

Drug: insulin degludec + liraglutide

Interventions

insulin degludec + liraglutide DRUG

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

Also known as: ideglira

insulin degludec + liraglutide ( ideglira)

Insulin Glargine - Insulin Aspart DRUG

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

basal group bolus

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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%.

Sponsors & Collaborators

• Hospital Universitario San Ignacio: lead

Study Sites (1)

Hospital Universitario San Ignacio

Bogotá, Colombia

RECRUITING

Related Publications (1)

• Gomez-Medina AM, Henao-Carillo DC, Villamil-Castaneda LP, Gomez-Quesada Y, Munoz-Velandia OM, Yepes CA, Chaim SN, Pertuz-Noriega CE, Aschner P. 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. Diabetologia. 2025 Sep;68(9):1899-1907. doi: 10.1007/s00125-025-06446-y. Epub 2025 Aug 4.

  PMID: 40760249 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 2

Interventions

IDegLira

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Ana Maria Gomez, MD

CONTACT

57(1)5 946161; agomez@husi.org.co

Yalinne Gómez Quesada, MD

CONTACT

57(1)5 946161; y.gomezq@javeriana.edu.co

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Eligible patients will be randomized 1:1 to continue the basal bolus ( insulin glargine and aspart ) or IDegLira ( insulin glargine and aspart ) or IDegLira ) on an outpatient basis by means of a system of random number generation through a mobile application ( Random Number Generator ) that will be centralized ( by a member of the independent group ) and to which the rest of the investigators will not have access.

Study Record Dates

• First Submitted: February 16, 2023
• First Posted: March 14, 2023
• Study Start: December 1, 2022
• Primary Completion: August 30, 2023
• Study Completion: August 30, 2023
• Last Updated: March 14, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1)