Diabetes Mellitus, Type 2 Treated With InsulinPhase 3NCT05767255
Risk of Hypoglycemia in the Transition From Inpatient to Outpatient Setting. Comparative Study of Basal-bolus Insulin Versus Basal Insulin Plus GLP-1 Analogue
A Phase 3 study testing insulin degludec + liraglutide and Insulin Glargine - Insulin Aspart in people with Diabetes Mellitus, Type 2 Treated With Insulin, run by Hospital Universitario San Ignacio at 1 site in Colombia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2 Treated With Insulin
- What is being tested?
- insulin degludec + liraglutide and Insulin Glargine - Insulin Aspart
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteColombia
- Study dates
- 1 Dec 2022to 30 Aug 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Show all 11Show fewer
- 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%.
Trial locations and contacts
1 site in 1 country.
Colombia1 site, 1 recruiting
- Recruiting
Hospital Universitario San Ignacio
Bogotá
Ana Maria Gomez Medina, MD, +57 (1) 5946161 ext. 2430, agomez@husi.org.co
Yalinne Gómez Gómez Quesada, MD, +57 (1) 5946161 ext. 2430, y.gomezq@javeriana.edu.co
About this study
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.
Read more
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.
Read the detailed description
Type 2 diabetes mellitus (DM 2) is a chronic non-communicable metabolic disease characterized by progressive deterioration of beta cell functionality, which associated with the presence of insulin resistance results in persistent elevations of plasma glucose or hyperglycemia. The objectives of its treatment are to prevent or delay complications and optimize quality of life.
The American Diabetes Association (ADA) consensus report "Standards of Medical Care in Diabetes-2021" recommends a patient-centered approach to choosing appropriate pharmacologic treatment of glycemia. This includes consideration of key patient factors: 1) important comorbidities, such as atherosclerotic cardiovascular disease, high-risk indicators of cardiovascular, chronic kidney disease, and heart failure, 2) risk of hypoglycemia, 3) effects on body weight, 4) side effects, 5) cost, and 6) patient preferences.
With these considerations in mind, drug therapy should be initiated in conjunction with a lifestyle modification consultation focused on diet and physical activity. Considering the progressive nature of the disease, monotherapy only achieves glycemic control for a few years and treatment intensification is required as the disease progresses, however, therapeutic inertia leads to delayed intensification in diabetic patients who are not at glycemic control goals, mainly when it comes to the use of injectable therapies such as insulins.
In recent years, two combinations of basal insulin with GLP-1 analog received regulatory approval from the European Medicines Agency and the U.S. Food and Drug Administration Agency. These therapeutic strategies are fixed ratio combinations of insulin degludec U100 and liraglutide (IDegLira); and insulin glargine U100 and lixisenatide (IGlarLixi). Both options demonstrated non-inferiority or superiority in reducing (Hb1Ac) levels in terms of glycemic control compared to their individual components in monotherapy, in the DUAL I study for IDegLira and in the LixiLan-O study for IGlarLixi .
Clinical trials supporting the efficacy and safety of IDegLira in the outpatient setting include DUAL (Dual Action of Liraglutide and Insulin Degludec in Type 2 Diabetes. On the other hand, there are authors who propose considering the use of IDegLira as the first injectable therapy in type 2 diabetic patients and as a therapeutic alternative in those who do not reach glycemic control goals with pharmacological treatment including monotherapy with GLP1 analogues, basal insulin or therapy with multiple doses of insulin in patients with recurrent hypoglycemia.
Considering the above, injectable therapy combined with IDegLira is proposed as an alternative for therapeutic intensification in patients with uncontrolled DM 2, since it has demonstrated efficacy and safety in the management of this pathology, achieving adequate glycemic control while leading to weight loss, lower rates of hypoglycemia and savings in insulin doses, in addition to providing a simple application scheme compared to the basal-bolus scheme.
In patients with DM 2, hospitalization represents an important change in medication: most consensus and guidelines propose the use of insulin therapy for glycemic control during hospital stay.
However, therapy at the time of hospital discharge should be adjusted and reconciled with the use of other non-insulin diabetes medications.
- Being tested
- insulin degludec + liraglutide, Insulin Glargine - Insulin Aspart
- Keywords
- IDegLira, Type 2 diabetes mellitus, Glycemic, Diabetes medications.
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
insulin degludec + liraglutideDrug
Also called ideglira
The association of insulin degludec with liraglutide in the same device (IDegLira) is a potent and safe drug that reduces the risk of hypoglycemia.
Insulin Glargine - Insulin AspartDrug
The insulin dose of the basal group will be adjusted according to the blood glucose reports presented by the patients.
| Study group | Role | What they receive |
|---|---|---|
| basal group bolus | Active comparator | * Insulin Glargine required on an in-hospital basis
* Insulin Aspart required on an in-hospital basis Receives: Drug: Insulin Glargine - Insulin Aspart |
| insulin degludec + liraglutide ( ideglira) | Experimental | 16 Units once a day Receives: Drug: insulin degludec + liraglutide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks
Secondary outcomes (7)
Compare episodes of severe hypoglycemia
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.
Measured: 4 weeks
Compare the metrics of glycemic control
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.
Measured: 4 weeks
Compare the incidence density of hypoglycemia
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.
Measured: 4 weeks
compare the percentage of patients without episodes of hypoglycemia
To compare the percentage of patients achieving a time in range greater than 70% without episodes of hypoglycemia in each intervention group.
Measured: 4 weeks
HbA1c change
To evaluate the efficacy of the schemes according to Hbac1 metrics before randomization.
Measured: 4 weeks
To assess whether there is a difference in body weight
To assess whether there is a difference in body weight change according to treatment allocation arm.
Measured: 4 weeks
Evaluate associated adverse effects
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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2023
- Study start1 Dec 2022
- Primary completion30 Aug 2023 (estimated)
- Study completion30 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2 Treated With InsulinStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario San Ignacio
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05767255
- Sponsor's protocol ID
- 2022/145
- Status last verified
- Feb 2023
- First submitted
- 16 Feb 2023
- Last updated
- 14 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make individual participant data (IPD) available to other researchers.
Publications
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.
PubMed 40760249
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk of Hypoglycemia in the Transition From Inpatient to Outpatient Setting. Comparative Study of Basal-bolus Insulin Versus Basal Insulin Plus GLP-1 Analogue
- ClinicalTrials.gov ID
- NCT05767255
- Acronym / sponsor ID
- 2022/145
- Keywords
- IDegLira, Type 2 diabetes mellitus, Glycemic, Diabetes medications.
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Hospital Universitario San IgnacioUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 30 Aug 2023 (estimated)
- Study completion
- 30 Aug 2023 (estimated)
- First posted
- 14 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Type 2 diabetes mellitus (DM 2) is a chronic non-communicable metabolic disease characterized by progressive deterioration of beta cell functionality, which associated with the presence of insulin resistance results in persistent elevations of plasma glucose or hyperglycemia. The objectives of its treatment are to prevent or delay complications and optimize quality of life.
The American Diabetes Association (ADA) consensus report "Standards of Medical Care in Diabetes-2021" recommends a patient-centered approach to choosing appropriate pharmacologic treatment of glycemia. This includes consideration of key patient factors: 1) important comorbidities, such as atherosclerotic cardiovascular disease, high-risk indicators of cardiovascular, chronic kidney disease, and heart failure, 2) risk of hypoglycemia, 3) effects on body weight, 4) side effects, 5) cost, and 6) patient preferences.
With these considerations in mind, drug therapy should be initiated in conjunction with a lifestyle modification consultation focused on diet and physical activity. Considering the progressive nature of the disease, monotherapy only achieves glycemic control for a few years and treatment intensification is required as the disease progresses, however, therapeutic inertia leads to delayed intensification in diabetic patients who are not at glycemic control goals, mainly when it comes to the use of injectable therapies such as insulins.
In recent years, two combinations of basal insulin with GLP-1 analog received regulatory approval from the European Medicines Agency and the U.S. Food and Drug Administration Agency. These therapeutic strategies are fixed ratio combinations of insulin degludec U100 and liraglutide (IDegLira); and insulin glargine U100 and lixisenatide (IGlarLixi). Both options demonstrated non-inferiority or superiority in reducing (Hb1Ac) levels in terms of glycemic control compared to their individual components in monotherapy, in the DUAL I study for IDegLira and in the LixiLan-O study for IGlarLixi .
Clinical trials supporting the efficacy and safety of IDegLira in the outpatient setting include DUAL (Dual Action of Liraglutide and Insulin Degludec in Type 2 Diabetes. On the other hand, there are authors who propose considering the use of IDegLira as the first injectable therapy in type 2 diabetic patients and as a therapeutic alternative in those who do not reach glycemic control goals with pharmacological treatment including monotherapy with GLP1 analogues, basal insulin or therapy with multiple doses of insulin in patients with recurrent hypoglycemia.
Considering the above, injectable therapy combined with IDegLira is proposed as an alternative for therapeutic intensification in patients with uncontrolled DM 2, since it has demonstrated efficacy and safety in the management of this pathology, achieving adequate glycemic control while leading to weight loss, lower rates of hypoglycemia and savings in insulin doses, in addition to providing a simple application scheme compared to the basal-bolus scheme.
In patients with DM 2, hospitalization represents an important change in medication: most consensus and guidelines propose the use of insulin therapy for glycemic control during hospital stay.
However, therapy at the time of hospital discharge should be adjusted and reconciled with the use of other non-insulin diabetes medications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| basal group bolus | Active comparator | Drug: Insulin Glargine - Insulin Aspart* Insulin Glargine required on an in-hospital basis * Insulin Aspart required on an in-hospital basis |
| insulin degludec + liraglutide ( ideglira) | Experimental | Drug: insulin degludec + liraglutide16 Units once a day |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| insulin degludec + liraglutideAlso: idegliraThe 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 degludec + liraglutide ( ideglira) |
| Insulin Glargine - Insulin AspartThe insulin dose of the basal group will be adjusted according to the blood glucose reports presented by the patients. | Drug | basal group bolus |
Primary outcome
To compare the percentage of hypoglycemia
Time frame: 4 weeks
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.
7 secondary outcomes
Compare episodes of severe hypoglycemia
Time frame: 4 weeks
Compare the metrics of glycemic control
Time frame: 4 weeks
Compare the incidence density of hypoglycemia
Time frame: 4 weeks
compare the percentage of patients without episodes of hypoglycemia
Time frame: 4 weeks
HbA1c change
Time frame: 4 weeks
To assess whether there is a difference in body weight
Time frame: 4 weeks
Evaluate associated adverse effects
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2023.
- Derived from this study: PubMed 40760249Gomez-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.
- Individual participant dataSharing planned: No. There is no plan to make individual participant data (IPD) available to other researchers.
Related trials for Diabetes Mellitus, Type 2 Treated With Insulin
Recruiting
Continuous Glucose Monitoring Systems in People With Type 2 Diabetes Not Treated With Insulin
Type 2 Diabetes
Not yet recruiting
A Novel Miniature Equine-Assisted Diabetes Education Program for Youth: Evaluating the Diabetes Equine Empowerment Program (DEEP).
Diabetes (Insulin-requiring, Type 1 or Type 2), Pediatric Diabetes
Not yet recruitingPhase 3
A Study Comparing SHR-3167 With Insulin Degludec in Adults With Type 2 Diabetes Currently Treated With Basal Insulin
Diabetes Mellitus, Type 2
Not yet recruiting
Physiologic Insulin Resensitization (PIR) Treatment in Patients With a Diagnosis of Type 2 Diabetes Mellitus (T2DM)
Type 2 Diabetes Mellitus
Not yet recruiting
Transitioning Recently Admitted Patients With Non-Insulin and Insulin-treated Type 2 Diabetes to Innovative Glucose Monitoring
Type 2 Diabetes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing insulin degludec + liraglutide and Insulin Glargine - Insulin Aspart in people with Diabetes Mellitus, Type 2 Treated With Insulin, run by Hospital Universitario San Ignacio at 1 site in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ana Maria Gomez, MD (57(1)5 946161, agomez@husi.org.co), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare the percentage of hypoglycemia (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05767255, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2023.