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Trial · Interventional

Status unknownPhase 3Registry data

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

NCTNCT05767255 (opens ClinicalTrials.gov in a new tab)Other id2022/145
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Status unknown
Phase
Phase 3
Enrollment
66 participants (estimated)
Sponsor
Hospital Universitario San Ignacio · Other
Design
Randomized · Open label (no masking)
Countries
1 country

Colombia

Start
1 Dec 2022
Primary completion
30 Aug 2023 (estimated)
Completion
30 Aug 2023 (estimated)
First posted
14 Mar 2023
Last update posted
14 Mar 2023
Conditions
Diabetes Mellitus, Type 2 Treated With Insulin

Timeline

1 trial

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
202220232024
  1. Ph 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

    NCT05767255

    1 Dec 2022 to est. 30 Aug 2023

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • insulin degludec + liraglutideDrug
  • Insulin Glargine - Insulin AspartDrug

Arms2

  • Active comparator

    basal group bolus

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

  • Experimental

    insulin degludec + liraglutide ( ideglira)

    16 Units once a day

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. To compare the percentage of hypoglycemia

    Time frame · 4 weeks

    Registry description

    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.

Secondary outcomes(7)

  1. Compare episodes of severe hypoglycemia

    Time frame · 4 weeks

    Registry description

    To compare episodes of severe hypoglycemia between the two groups; defined as episodes with altered state of consciousness or requiring assistance from another person to make corrective decisions.

  2. Compare the metrics of glycemic control

    Time frame · 4 weeks

    Registry description

    To compare the metrics of glycemic control (time in range 70-180 mg/dL, time above range 180 mg/dL, time above 250 mg/dL , GMI, coefficient of variation ) of the two groups.

  3. Compare the incidence density of hypoglycemia

    Time frame · 4 weeks

    Registry description

    To compare the incidence density of hypoglycemia defined as the number of hypoglycemia events (readings below 54 mg/ dL for more than 20 minutes by continuous flash glucose monitoring) in each intervention group.

  4. compare the percentage of patients without episodes of hypoglycemia

    Time frame · 4 weeks

    Registry description

    To compare the percentage of patients achieving a time in range greater than 70% without episodes of hypoglycemia in each intervention group.

  5. HbA1c change

    Time frame · 4 weeks

    Registry description

    To evaluate the efficacy of the schemes according to Hbac1 metrics before randomization.

  6. To assess whether there is a difference in body weight

    Time frame · 4 weeks

    Registry description

    To assess whether there is a difference in body weight change according to treatment allocation arm.

  7. Evaluate associated adverse effects

    Time frame · 4 weeks

    Registry description

    Evaluate and compare associated adverse effects such as: nausea, emesis, abdominal distension, diarrhea, constipation, epigastric pain, early satiety, postprandial fullness, weight gain, acute pancreatitis, symptomatic cholelithiasis, diabetic ketoacidosis, hyperosmolar state (see attached operational definitions).They will be evaluated by means of the CTCAE manual version 5.0.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2025

6 results

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.

Gómez-Medina et al. 2025Diabetologiacited by 1

PMID 40760249PMC12361261DOI 10.1007/s00125-025-06446-yPUB-40760249

CC BY6 results
Download PDFSee results (6)

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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%.

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