Diabetes Mellitus, Type 2Phase 4NCT05360537
Effects of Degludec/Liraglutide on Time in Range, Inflammation and Endothelial Function vs Insulin Basal Bolus in Diabetic Inpatients
A Phase 4 study testing Insulin Degludec / Liraglutide Injectable Product and Insulin Glargine in people with Diabetes Mellitus, Type 2, run by University of Palermo at 1 site in Italy.
Trial summary
The study aims to evaluate the effects of Insulin Degludec/Liraglutide on glycemic variability assessed by continuous glycemic monitoring with the function time in range, serum markers of inflammation, markers of endothelial dysfunction and a possible correlation with intra and extra-hospital mortality rates in a… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Insulin Degludec / Liraglutide Injectable Product and Insulin Glargine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 1 Apr 2021to 20 Apr 2022
- Phase
- Phase 4
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diabetes mellitus type 2
- Mild-moderate Hyperglycemia (180-400 mg/dl)
- Acute events (Pneumonia, Acute cardiac Ischemia, Ictus, IVU)
Who cannot join
- Diabetes mellitus type 1
- Diabetic ketoacidosis
- Hyperosmolar coma
- Severe hypoglycaemia
- Acute Pancreatitis
- Cancer
Show all 9Show fewer
- use of corticosteroids
- pregnancy
- Chronic kidney disease (< 30 ml/min) or hemodialysis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Degludec/Liraglutide on Time in Range, Markers of Inflammation and Endothelial Dysfunction Compared to Scheme Insulin Basal Bolus, in a Population of Diabetic Inpatients and Possible Correlation With Intra-hospital Mortality Rates
The study aims to evaluate the effects of Insulin Degludec/Liraglutide on glycemic variability assessed by continuous glycemic monitoring with the function time in range, serum markers of inflammation, markers of endothelial dysfunction and a possible correlation with intra and extra-hospital mortality rates in a group of hospitalized diabetic patients compared to a control group of in-patient diabetic in treatment on insulin Basal-bolus.
Read the detailed description
100 patients with type 2 diabetes mellitus were recruited at the Internal Medicine with Stroke care ward of the University hospital of Palermo "P. Giaccone" from April 2022 to April 2024. 50 patients were treated with Insulin Degludec/Liraglutide, 50 were undertaken treatment regime with Insulin Basal Bolus (control group).
The study was carried out in accordance with the principles of the Helsinki Declaration revised in 2001 and all patients gave their written consent to take part in this research.
Each patient treated was compared for age, sex and cardiovascular risk with control patients. The diagnosis of type 2 diabetes mellitus was based on the revised criteria of the American Diabetes Association (ADA), and using a clinical algorithm that considered the age of onset of the disease, the symptoms and weight present, the family history and the therapy practiced. Arterial hypertension was defined according to the 2017 ESC-ESH criteria. Dyslipidemia was defined based on total cholesterol levels> 200 mg/dl, triglycerides> 150 mg/dl and HDL levels <40 mg/dl regardless of the patient's gender.
Among the cases enrolled, 135 (100%) had type 2 diabetes mellitus, 110 (80 %) had arterial hypertension and 74 (55%) hypercholesterolemia.
Clinical and anthropometric data were collected at the time of recruitment. Blood samples were taken from each patient (cases and controls) to determine serum glucose, HbA1c, CRP, Ferritin, IL-6. These withdrawals were then repeated three months and six months from the time of recruitment.
The glycemic variability was assessed by continuous glycemic monitoring with the analysis of Time in Range
The digital endothelial function was evaluated through the RHI-pat analysis using Endo-PAT2000.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Insulin Degludec / Liraglutide Injectable Product, Insulin Glargine
- Keywords
- Insulin Degludec/Liraglutide
- Medical subject headings
- 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 / Liraglutide Injectable ProductDrug
Also called Insulin Degludec/Liraglutide
administration of Insulin Degludec/Liraglutide
Insulin GlargineDrug
Also called glargine
Administration of glargine insulin
| Study group | Role | What they receive |
|---|---|---|
| patients treated with Insulin Degludec/Liraglutide | Experimental | Diabetes therapy with Insulin Degludec/Liraglutide and various combinations of metformin, repaglinide, sulfonylureas. Receives: Drug: Insulin Degludec / Liraglutide Injectable Product |
| patients treated with Insulin regime Basal Bolus | Active comparator | Diabetes therapy with the combination of a single administration of glargine insulin and three administration of Aspart Insulin. Receives: Drug: Insulin Glargine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Time in Range % at 7 days, at 1 and 6 months
Evaluation of Time in Range % by continuous glycemic monitoring
Measured: 7 days, 1 months and 6 months
Change of hypoglycemic events
Change of hypoglycemic events (symptoms and serum glycemia < 60 mg/dl)
Measured: 7 days, 1 months and 6 months
Change from Baseline Reactive Hyperemia Index at 3 and 9 months
Change of Endothelial function by the use of Endopat2000 with the evaluation of Reactive Hypereremia Index (normal value of RHI > 1,27)
Measured: 7 days, 1 months and 6 months
Secondary outcomes (4)
Change from Baseline serum of C- Reactive-Protein (CRP)
Variation from baseline serum levels of C- Reactive-Protein (CRP) (mg/dl)
Measured: 7 days, 1 months and 6 months
Change from Baseline serum levels of Interleukin-6 (IL6)
Variation from baseline serum levels of Interleukin-6 (IL6) (pg/ml)
Measured: 7 days, 1 months and 6 months
Change from Baseline serum levels of ferritin
Variation from baseline serum levels of ferritin (mcg/L)
Measured: 7 days, 1 months and 6 months
Change of intra and extra-hospital mortality
Change of intra and extra-hospital mortality
Measured: 7 days, 1 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2022
- Study start1 Apr 2021
- Primary completion1 Dec 2021
- Study completion20 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Palermo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonino Tuttolomondo, University of Palermo
- Investigators
- Antonino Tuttolomondo, Professor, Study director, University of Palermo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05360537
- Sponsor's protocol ID
- U Palermo
- Status last verified
- Dec 2023
- First submitted
- 20 Apr 2022
- Last updated
- 15 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Degludec/Liraglutide on Time in Range, Markers of Inflammation and Endothelial Dysfunction Compared to Scheme Insulin Basal Bolus, in a Population of Diabetic Inpatients and Possible Correlation With Intra-hospital Mortality Rates
- ClinicalTrials.gov ID
- NCT05360537
- Acronym / sponsor ID
- U Palermo
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Insulin Degludec/Liraglutide
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of PalermoUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 20 Apr 2022 (actual)
- First posted
- 4 May 2022 (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 study aims to evaluate the effects of Insulin Degludec/Liraglutide on glycemic variability assessed by continuous glycemic monitoring with the function time in range, serum markers of inflammation, markers of endothelial dysfunction and a possible correlation with intra and extra-hospital mortality rates in a group of hospitalized diabetic patients compared to a control group of in-patient diabetic in treatment on insulin Basal-bolus.
Detailed description
100 patients with type 2 diabetes mellitus were recruited at the Internal Medicine with Stroke care ward of the University hospital of Palermo "P. Giaccone" from April 2022 to April 2024. 50 patients were treated with Insulin Degludec/Liraglutide, 50 were undertaken treatment regime with Insulin Basal Bolus (control group).
The study was carried out in accordance with the principles of the Helsinki Declaration revised in 2001 and all patients gave their written consent to take part in this research.
Each patient treated was compared for age, sex and cardiovascular risk with control patients. The diagnosis of type 2 diabetes mellitus was based on the revised criteria of the American Diabetes Association (ADA), and using a clinical algorithm that considered the age of onset of the disease, the symptoms and weight present, the family history and the therapy practiced. Arterial hypertension was defined according to the 2017 ESC-ESH criteria. Dyslipidemia was defined based on total cholesterol levels> 200 mg/dl, triglycerides> 150 mg/dl and HDL levels <40 mg/dl regardless of the patient's gender.
Among the cases enrolled, 135 (100%) had type 2 diabetes mellitus, 110 (80 %) had arterial hypertension and 74 (55%) hypercholesterolemia.
Clinical and anthropometric data were collected at the time of recruitment. Blood samples were taken from each patient (cases and controls) to determine serum glucose, HbA1c, CRP, Ferritin, IL-6. These withdrawals were then repeated three months and six months from the time of recruitment.
The glycemic variability was assessed by continuous glycemic monitoring with the analysis of Time in Range
The digital endothelial function was evaluated through the RHI-pat analysis using Endo-PAT2000.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| patients treated with Insulin Degludec/Liraglutide | Experimental | Drug: Insulin Degludec / Liraglutide Injectable ProductDiabetes therapy with Insulin Degludec/Liraglutide and various combinations of metformin, repaglinide, sulfonylureas. |
| patients treated with Insulin regime Basal Bolus | Active comparator | Drug: Insulin GlargineDiabetes therapy with the combination of a single administration of glargine insulin and three administration of Aspart Insulin. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diabetes mellitus type 2
- Mild-moderate Hyperglycemia (180-400 mg/dl)
- Acute events (Pneumonia, Acute cardiac Ischemia, Ictus, IVU)
Key exclusion criteria (9 listed)
- Diabetes mellitus type 1
- Diabetic ketoacidosis
- Hyperosmolar coma
- Severe hypoglycaemia
- Acute Pancreatitis
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 / Liraglutide Injectable ProductAlso: Insulin Degludec/Liraglutideadministration of Insulin Degludec/Liraglutide | Drug | patients treated with Insulin Degludec/Liraglutide |
| Insulin GlargineAlso: glargineAdministration of glargine insulin | Drug | patients treated with Insulin regime Basal Bolus |
Primary outcome
Change of Time in Range % at 7 days, at 1 and 6 months
Time frame: 7 days, 1 months and 6 months
Evaluation of Time in Range % by continuous glycemic monitoring
Change of hypoglycemic events
Time frame: 7 days, 1 months and 6 months
Change of hypoglycemic events (symptoms and serum glycemia < 60 mg/dl)
Change from Baseline Reactive Hyperemia Index at 3 and 9 months
Time frame: 7 days, 1 months and 6 months
Change of Endothelial function by the use of Endopat2000 with the evaluation of Reactive Hypereremia Index (normal value of RHI > 1,27)
4 secondary outcomes
Change from Baseline serum of C- Reactive-Protein (CRP)
Time frame: 7 days, 1 months and 6 months
Change from Baseline serum levels of Interleukin-6 (IL6)
Time frame: 7 days, 1 months and 6 months
Change from Baseline serum levels of ferritin
Time frame: 7 days, 1 months and 6 months
Change of intra and extra-hospital mortality
Time frame: 7 days, 1 months and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2023.
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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.
Antonino Tuttolomondo, Professor study director
University of Palermo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Insulin Degludec / Liraglutide Injectable Product and Insulin Glargine in people with Diabetes Mellitus, Type 2, run by University of Palermo at 1 site in Italy.
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 3 inclusion and 9 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: finished, as of the sponsor's last update on 15 Dec 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 Italy. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Time in Range % at 7 days, at 1 and 6 months (time frame: 7 days, 1 months and 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Dec 2023.