Type 2 DiabetesPhase 4BEYONDNCT04196231
Durability of Combination of Insulin and GLP-1 Receptor Agonist or SGLT-2 Inhibitors Versus Basal Bolus Insulin Regimen in Type 2 Diabetes (BEYOND)
A Phase 4 study testing IDegLira, IGlarLixi and Insulin/Canaglifozin in people with Type 2 Diabetes, run by University of Campania Luigi Vanvitelli at 1 site in Italy.
Trial summary
BEYOND represents an open-label, parallel, three-arm randomized controlled trial, aimed at evaluating the effects of combination therapy of fixed ratio basal insulin/GLP-1 receptor agonist (GLP-1RA) or basal insulin/SGLT-2 inhibitors (SGLT-2i) on the durability of the glycemic control, as compared with the basal bolus… Read more about this study
- Who is it for?
- Ages 35 to 75 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- IDegLira, IGlarLixi and Insulin/Canaglifozin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 258 participants
- Where
- 1 siteItaly
- Study dates
- 27 Nov 2019to 20 Oct 2020
- 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 35 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Poor glycemic control (HbA1c ≥7.5%)
- Stable basal bolus insulin regimen for almost a year, eventually associated with metformin.
Who cannot join
- Type 1 diabetes or secondary diabetes;
- Previous treatment for the last three months with GLP-1RA or DPP-4 inhibitors;
- Hypersensitivity towards active substances or other ingredients of the drugs used in the study
- Participation in other trial with experimental drugs within 30 days
- Diseases that represent contraindication to GLP-1RA use (pancreatitis, gallstones)
- Pregnancy or planned pregnancy within the time of the study
Show all 12Show fewer
- Serum creatinine > 1,3 mg/dL in women and >1,4 mg/dL in men
- eGFR < 30 mL/min
- Previous cancer or antineoplastic therapy for five years before randomization
- Current therapy with glucocorticoid (oral, topic or sistemic administration) or with antypsichotic drugs
- Previous ketoacidosis
- Any clinical, psychologic or psychiatric condition that is incompatible with the study according to the investigator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Durability of Combination of Insulin and GLP-1 Receptor Agonist or SGLT-2 Inhibitors Versus Basal Bolus Insulin Regimen in Type 2 Diabetes: a Randomized Controlled Trial
BEYOND represents an open-label, parallel, three-arm randomized controlled trial, aimed at evaluating the effects of combination therapy of fixed ratio basal insulin/GLP-1 receptor agonist (GLP-1RA) or basal insulin/SGLT-2 inhibitors (SGLT-2i) on the durability of the glycemic control, as compared with the basal bolus insulin regimen, in people with type 2 diabetes failing to achieve glycemic targets with injective therapy. The potential benefits for participants in the study include the possibility of improving the glyco-metabolic control with drugs that have been evaluated as safe and protective for the heart and the kidneys. The primary outcome of the study is the mean HbA1c change between groups at six months. Participants in the study will be followed for subsequent 18 months in order to evaluate the durability of glycemic control and the chenge of other secondary outcomes.
- Conditions
- Type 2 Diabetes
- Being tested
- IDegLira, IGlarLixi, Insulin/Canaglifozin, Insulin/Dapaglifozin, Insulin/Empaglifozin
- Keywords
- type 2 diabetes, GLP-1RA, SGLT-2i, basal insulin, basal bolus, glycemic control
- 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.
IDegLiraDrug
IDegLira will be started at 16 dose steps (16 U insulin degludec plus 0.58 mg liraglutide, once daily). On the basis of prebreakfast self-monitored blood glucose measurements doses of IDegLira will be titrated individually twice per week to achieve a prebreakfast plasma glucose of 80-130 mg/dL by use of an algorithm (adding 2 dose steps for prebreakfast plasma glucose >130 mg/dL; no dose change for prebreakfast plasma glucose of 80-130 mg/dL; reducing 2 dose steps for prebreakfast plasma glucose < 80 mg/dL). The daily dose of IDegLira could be titrated to 50 dose steps (50 U insulin degludec plus 1.8 mg liraglutide).
IGlarLixiDrug
IGlarLixi will be started at 10 dose steps (10 U insulin glargine plus 5 mcg lixisenatide, once daily). On the basis of prebreakfast self-monitored blood glucose measurements, doses of IGlarLixi will be titrated individually once per week to achieve a prebreakfast plasma glucose of 80-130 mg/dL by use of an algorithm (adding 2 dose steps for prebreakfast plasma glucose >130 mg/dL; no dose change for prebreakfast plasma glucose of 80-130 mg/dL; reducing 2 dose steps for prebreakfast plasma glucose < 80 mg/dL). The daily dose of IGlarLixi could be titrated to 60 dose steps (60 U insulin degludec plus 20 mcg lixisenatide).
Insulin/CanaglifozinDrug
Patients in this arm will continue the basal insulin used before the randomization, with dosage titration on the basis of the following algorithm: adding 2 units for prebreakfast plasma glucose >130 mg/dL; no dose change for prebreakfast plasma glucose of 80-130 mg/dL; reducing 2 units for prebreakfast plasma glucose < 80 mg/dL. Moreover, they will be assigned to canaglifozin, according to the current clinical practice and the drugs' data sheet. Canagliflozin will be started at 100 mg daily per oral administration, and augmented to 300 mg/per day if required (HbA1c >7.5 after 12 weeks).
Insulin/DapaglifozinDrug
Patients in this arm will continue the basal insulin used before the randomization, with dosage titration on the basis of the following algorithm: adding 2 units for prebreakfast plasma glucose >130 mg/dL; no dose change for prebreakfast plasma glucose of 80-130 mg/dL; reducing 2 units for prebreakfast plasma glucose < 80 mg/dL. Moreover, they will be assigned to dapaglifozin, according to the current clinical practice and the drugs' data sheet. Dapagliflozin will be started at 10 mg daily per oral administration
Insulin/EmpaglifozinDrug
Patients in this arm will continue the basal insulin used before the randomization, with dosage titration on the basis of the following algorithm: adding 2 units for prebreakfast plasma glucose >130 mg/dL; no dose change for prebreakfast plasma glucose of 80-130 mg/dL; reducing 2 units for prebreakfast plasma glucose < 80 mg/dL. Moreover, they will be assigned to empaglifozin, according to the current clinical practice and the drugs' data sheet. Empagliflozin will be started at 10 mg daily per oral administration, and augmented to 25 mg/per day if required (HbA1c >7.5 after 12 weeks).
Basal BolusDrug
Patients in this arm will continue the basal insulin (glargine, degludec or glargine-300) used before the randomization. The insulin titration will be guided by the medical staff, according to the following algorithm: adding 2 units of basal insulin for prebreakfast plasma glucose >130 mg/dL; no dose change for prebreakfast plasma glucose of 80-130 mg/dL; reducing 2 units of basal insulin for prebreakfast plasma glucose < 80 mg/dL. The short acting insulin analogue (lispro, aspart or glulisine) will be started at the dosage of 4 units before meals (3 times per day) and will be titrated twice a week until achieving pre-prandial glucose values ranging from 80-130 mg/dL.
| Study group | Role | What they receive |
|---|---|---|
| FR insulin/GLP-1RA | Active comparator | Patients in this arm will receive one of these fixed ratio combo of insulin and GLP-1RAs, according to the current clinical practice and the drugs' data sheet: IDegLira or IGlarLixi Receives: Drug: IDegLira; Drug: IGlarLixi |
| Insulin/SGLT-2i | Active comparator | Patients in this arm will receive the basal insulin used before the randomization and one of these SGLT-2i according to the current clinical practice and the drugs' data sheet: canagliflozin, dapagliflozin or empagliflozin. Receives: Drug: Insulin/Canaglifozin; Drug: Insulin/Dapaglifozin; Drug: Insulin/Empaglifozin |
| Basal Bolus | Active comparator | Patients in this arm will receive a basal insulin (glargine, glargine-300 or degludec) at bed-time plus 3 injections of a short-acting insulin analogue (aspart, lispro or glulisine) before meals Receives: Drug: Basal Bolus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hba1c change
HbA1c group difference at 6 months
Measured: 6 months, 9 months, 12 months
Proportions of patients with significant HbA1c change
Proportions of patients undergoing a reduction equal or higher than 0.5% as compared with baseline levels during the follow up
Measured: Baseline, 3 months, 6 months, 9 months, 12 months, 18 months
Secondary outcomes (11)
Weight Change
Measured: Baseline, 6 months, 18 months
BMI Change
Measured: Baseline, 6 months, 18 months
Waist circumference change
Measured: Baseline, 6 months, 18 months
Blood pressure change
Measured: Baseline, 6 months, 18 months
Fasting glycemia change
Measured: Baseline, 6 months, 18 months
Post-prandial glycemia change
Measured: Baseline, 6 months, 18 months
C-peptide change
Measured: Baseline, 6 months, 18 months
Change in total daily insulin dose
Measured: Baseline, 6 months, 18 months
Change in lipide profile
Difference between groups in total cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides
Measured: Baseline, 6 months, 18 months
Change in eGFR
Measured: Baseline, 6 months, 18 months
Diabetes treatment satisfaction
In order to measure satisfaction with diabetes treatment regimens, we used the self-reported Diabetes Treatment Satisfaction Questionnaire. This instrument aims to assess levels of satisfaction in subjects using different treatment strategies. The questionnaire consists of eight questions: six questions addresses general satisfaction with a score from 0 to 6 for each question (0 = worst), that has to be computed in a total score ranging from 0 (=worst) to 36 (=best); among the remaining two questions, which has to be computed separately as two subscales, one concerns the perception of hyperglycemic events and another the perception of hypoglycemic events, both with a score from 0 (none of the time) to 6 (most of the time).
Measured: Baseline, 6 months, 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2019
- Study start27 Nov 2019
- Primary completion30 Sep 2020
- Study completion20 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies 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
- Masking
- None (open label)
- Enrolment
- 258 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Campania Luigi Vanvitelli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katherine Esposito, University of Campania Luigi Vanvitelli
- Investigators
- Katherine Esposito, MD, PhD, Principal investigator, Unit of Diabetology University of Campania Luigi VanvitelliDario Giugliano, MD, Principal investigator, Unit of Endocrinology and Metabolic Diseases University of Campania Luigi VanvitelliGiuseppe Bellastella, MD, PhD, Study chair, Unit of Endocrinology and Metabolic Diseases University of Campania Luigi VanvitelliMaria Ida Maiorino, MD, PhD, Study chair, Unit of Diabetology University of Campania Luigi Vanvitelli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04196231
- Sponsor's protocol ID
- BEYOND Protocol
- Acronym
- BEYOND
- Status last verified
- Oct 2020
- First submitted
- 6 Dec 2019
- Last updated
- 22 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Giugliano D, Bellastella G, Maiorino MI, Esposito K. Beyond basal-bolus insulin regimen: Is it still the ultimate chance for therapy in diabetes? Diabetes Res Clin Pract. 2019 Nov;157:107922. doi: 10.1016/j.diabres.2019.107922. Epub 2019 Nov 9. No abstract available.
PubMed 31715201Giugliano D, Longo M, Scappaticcio L, Caruso P, Gicchino M, Petrizzo M, Bellastella G, Maiorino MI, Esposito K. BEYOND 2 years: durability of metabolic benefits by simplification of complex insulin regimens in type 2 diabetes. Endocrine. 2024 Feb;83(2):399-404. doi: 10.1007/s12020-023-03547-9. Epub 2023 Oct 3.
PubMed 37787888Giugliano D, Longo M, Caruso P, Di Fraia R, Scappaticcio L, Gicchino M, Petrizzo M, Bellastella G, Maiorino MI, Esposito K. Feasibility of Simplification From a Basal-Bolus Insulin Regimen to a Fixed-Ratio Formulation of Basal Insulin Plus a GLP-1RA or to Basal Insulin Plus an SGLT2 Inhibitor: BEYOND, a Randomized, Pragmatic Trial. Diabetes Care. 2021 Jun;44(6):1353-1360. doi: 10.2337/dc20-2623. Epub 2021 Apr 21.
PubMed 33883195
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Durability of Combination of Insulin and GLP-1 Receptor Agonist or SGLT-2 Inhibitors Versus Basal Bolus Insulin Regimen in Type 2 Diabetes: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04196231
- Acronym / sponsor ID
- BEYOND / BEYOND Protocol
- Conditions
- Type 2 Diabetes
- Keywords
- type 2 diabetes, GLP-1RA, SGLT-2i, basal insulin, basal bolus, glycemic control
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 258 participants (actual)
- Lead sponsor
- University of Campania Luigi VanvitelliUniversity, hospital or other
- Study start
- 27 Nov 2019 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 20 Oct 2020 (actual)
- First posted
- 12 Dec 2019 (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.
BEYOND represents an open-label, parallel, three-arm randomized controlled trial, aimed at evaluating the effects of combination therapy of fixed ratio basal insulin/GLP-1 receptor agonist (GLP-1RA) or basal insulin/SGLT-2 inhibitors (SGLT-2i) on the durability of the glycemic control, as compared with the basal bolus insulin regimen, in people with type 2 diabetes failing to achieve glycemic targets with injective therapy. The potential benefits for participants in the study include the possibility of improving the glyco-metabolic control with drugs that have been evaluated as safe and protective for the heart and the kidneys. The primary outcome of the study is the mean HbA1c change between groups at six months. Participants in the study will be followed for subsequent 18 months in order to evaluate the durability of glycemic control and the chenge of other secondary outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| FR insulin/GLP-1RA | Active comparator | Drug: IDegLira, Drug: IGlarLixiPatients in this arm will receive one of these fixed ratio combo of insulin and GLP-1RAs, according to the current clinical practice and the drugs' data sheet: IDegLira or IGlarLixi |
| Insulin/SGLT-2i | Active comparator | Drug: Insulin/Canaglifozin, Drug: Insulin/Dapaglifozin, Drug: Insulin/EmpaglifozinPatients in this arm will receive the basal insulin used before the randomization and one of these SGLT-2i according to the current clinical practice and the drugs' data sheet: canagliflozin, dapagliflozin or empagliflozin. |
| Basal Bolus | Active comparator | Drug: Basal BolusPatients in this arm will receive a basal insulin (glargine, glargine-300 or degludec) at bed-time plus 3 injections of a short-acting insulin analogue (aspart, lispro or glulisine) before meals |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Poor glycemic control (HbA1c ≥7.5%)
- Stable basal bolus insulin regimen for almost a year, eventually associated with metformin.
Key exclusion criteria (12 listed)
- Type 1 diabetes or secondary diabetes;
- Previous treatment for the last three months with GLP-1RA or DPP-4 inhibitors;
- Hypersensitivity towards active substances or other ingredients of the drugs used in the study
- Participation in other trial with experimental drugs within 30 days
- Diseases that represent contraindication to GLP-1RA use (pancreatitis, gallstones)
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 |
|---|---|---|
| IDegLiraIDegLira will be started at 16 dose steps (16 U insulin degludec plus 0.58 mg liraglutide, once daily). On the basis of prebreakfast self-monitored blood glucose measurements doses of IDegLira will be titrated individually twice per week to achieve a prebreakfast plasma glucose of 80-130 mg/dL by use of an algorithm (adding 2 dose steps for prebreakfast plasma glucose >130 mg/dL; no dose change for prebreakfast plasma glucose of 80-130 mg/dL; reducing 2 dose steps for prebreakfast plasma glucose < 80 mg/dL). The daily dose of IDegLira could be titrated to 50 dose steps (50 U insulin degludec plus 1.8 mg liraglutide). | Drug | FR insulin/GLP-1RA |
| IGlarLixiIGlarLixi will be started at 10 dose steps (10 U insulin glargine plus 5 mcg lixisenatide, once daily). On the basis of prebreakfast self-monitored blood glucose measurements, doses of IGlarLixi will be titrated individually once per week to achieve a prebreakfast plasma glucose of 80-130 mg/dL by use of an algorithm (adding 2 dose steps for prebreakfast plasma glucose >130 mg/dL; no dose change for prebreakfast plasma glucose of 80-130 mg/dL; reducing 2 dose steps for prebreakfast plasma glucose < 80 mg/dL). The daily dose of IGlarLixi could be titrated to 60 dose steps (60 U insulin degludec plus 20 mcg lixisenatide). | Drug | FR insulin/GLP-1RA |
| Insulin/CanaglifozinPatients in this arm will continue the basal insulin used before the randomization, with dosage titration on the basis of the following algorithm: adding 2 units for prebreakfast plasma glucose >130 mg/dL; no dose change for prebreakfast plasma glucose of 80-130 mg/dL; reducing 2 units for prebreakfast plasma glucose < 80 mg/dL. Moreover, they will be assigned to canaglifozin, according to the current clinical practice and the drugs' data sheet. Canagliflozin will be started at 100 mg daily per oral administration, and augmented to 300 mg/per day if required (HbA1c >7.5 after 12 weeks). | Drug | Insulin/SGLT-2i |
| Insulin/DapaglifozinPatients in this arm will continue the basal insulin used before the randomization, with dosage titration on the basis of the following algorithm: adding 2 units for prebreakfast plasma glucose >130 mg/dL; no dose change for prebreakfast plasma glucose of 80-130 mg/dL; reducing 2 units for prebreakfast plasma glucose < 80 mg/dL. Moreover, they will be assigned to dapaglifozin, according to the current clinical practice and the drugs' data sheet. Dapagliflozin will be started at 10 mg daily per oral administration | Drug | Insulin/SGLT-2i |
| Insulin/EmpaglifozinPatients in this arm will continue the basal insulin used before the randomization, with dosage titration on the basis of the following algorithm: adding 2 units for prebreakfast plasma glucose >130 mg/dL; no dose change for prebreakfast plasma glucose of 80-130 mg/dL; reducing 2 units for prebreakfast plasma glucose < 80 mg/dL. Moreover, they will be assigned to empaglifozin, according to the current clinical practice and the drugs' data sheet. Empagliflozin will be started at 10 mg daily per oral administration, and augmented to 25 mg/per day if required (HbA1c >7.5 after 12 weeks). | Drug | Insulin/SGLT-2i |
| Basal BolusPatients in this arm will continue the basal insulin (glargine, degludec or glargine-300) used before the randomization. The insulin titration will be guided by the medical staff, according to the following algorithm: adding 2 units of basal insulin for prebreakfast plasma glucose >130 mg/dL; no dose change for prebreakfast plasma glucose of 80-130 mg/dL; reducing 2 units of basal insulin for prebreakfast plasma glucose < 80 mg/dL. The short acting insulin analogue (lispro, aspart or glulisine) will be started at the dosage of 4 units before meals (3 times per day) and will be titrated twice a week until achieving pre-prandial glucose values ranging from 80-130 mg/dL. | Drug | Basal Bolus |
Primary outcome
Hba1c change
Time frame: 6 months, 9 months, 12 months
HbA1c group difference at 6 months
Proportions of patients with significant HbA1c change
Time frame: Baseline, 3 months, 6 months, 9 months, 12 months, 18 months
Proportions of patients undergoing a reduction equal or higher than 0.5% as compared with baseline levels during the follow up
11 secondary outcomes
Weight Change
Time frame: Baseline, 6 months, 18 months
BMI Change
Time frame: Baseline, 6 months, 18 months
Waist circumference change
Time frame: Baseline, 6 months, 18 months
Blood pressure change
Time frame: Baseline, 6 months, 18 months
Fasting glycemia change
Time frame: Baseline, 6 months, 18 months
Post-prandial glycemia change
Time frame: Baseline, 6 months, 18 months
C-peptide change
Time frame: Baseline, 6 months, 18 months
Change in total daily insulin dose
Time frame: Baseline, 6 months, 18 months
Change in lipide profile
Time frame: Baseline, 6 months, 18 months
Change in eGFR
Time frame: Baseline, 6 months, 18 months
Diabetes treatment satisfaction
Time frame: Baseline, 6 months, 18 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 22 Oct 2020.
- Background: PubMed 31715201Giugliano D, Bellastella G, Maiorino MI, Esposito K. Beyond basal-bolus insulin regimen: Is it still the ultimate chance for therapy in diabetes? Diabetes Res Clin Pract. 2019 Nov;157:107922. doi: 10.1016/j.diabres.2019.107922. Epub 2019 Nov 9. No abstract available.
- Derived from this study: PubMed 37787888Giugliano D, Longo M, Scappaticcio L, Caruso P, Gicchino M, Petrizzo M, Bellastella G, Maiorino MI, Esposito K. BEYOND 2 years: durability of metabolic benefits by simplification of complex insulin regimens in type 2 diabetes. Endocrine. 2024 Feb;83(2):399-404. doi: 10.1007/s12020-023-03547-9. Epub 2023 Oct 3.
- Derived from this study: PubMed 33883195Giugliano D, Longo M, Caruso P, Di Fraia R, Scappaticcio L, Gicchino M, Petrizzo M, Bellastella G, Maiorino MI, Esposito K. Feasibility of Simplification From a Basal-Bolus Insulin Regimen to a Fixed-Ratio Formulation of Basal Insulin Plus a GLP-1RA or to Basal Insulin Plus an SGLT2 Inhibitor: BEYOND, a Randomized, Pragmatic Trial. Diabetes Care. 2021 Jun;44(6):1353-1360. doi: 10.2337/dc20-2623. Epub 2021 Apr 21.
- Individual participant dataSharing planned: No
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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.
Katherine Esposito, MD, PhD principal investigator
Unit of Diabetology University of Campania Luigi Vanvitelli
Dario Giugliano, MD principal investigator
Unit of Endocrinology and Metabolic Diseases University of Campania Luigi Vanvitelli
Giuseppe Bellastella, MD, PhD study chair
Unit of Endocrinology and Metabolic Diseases University of Campania Luigi Vanvitelli
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 IDegLira, IGlarLixi and Insulin/Canaglifozin in people with Type 2 Diabetes, run by University of Campania Luigi Vanvitelli 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 2 inclusion and 12 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 22 Oct 2020. 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?
Hba1c change (time frame: 6 months, 9 months, 12 months). The study lists 2 primary outcomes in all. 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 NCT04196231, which also lists 3 linked publications.
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 22 Oct 2020.