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BEYOND

CompletedPhase 4

Durability of Combination of Insulin and GLP-1 Receptor Agonist or SGLT-2 Inhibitors Versus Basal Bolus Insulin Regimen in Type 2 Diabetes (BEYOND)

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

Lead sponsor

University of Campania Luigi Vanvitelli

Assets

GLP-1 / incretin class catch-all / Liraglutide / Lixisenatide

Listed sites

Recruiting sites

—

Enrollment

258

actual

Study population

Type 2 diabetes

Key I/E criterion

•HbA1c ≥7.5%

Primary endpoint

•HbA1c, change

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT04196231

Org study IDBEYOND Protocol

Timeline

Milestones

Study start2019-11-27actual

Study first posted2019-12-12actual

Primary completion2020-09-30actual

Study completion2020-10-20actual

Last update posted2020-10-22actual

Assets

Investigational agents

GLP-1 / incretin class catch-all Liraglutide Lixisenatide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age35 Years

Maximum age75 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Poor glycemic control (HbA1c ≥7.5%)

•Stable basal bolus insulin regimen for almost a year, eventually associated with metformin.

Exclusion criteria

•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

•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

Endpoints (13)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Glycemic / diabetes

Weight & body composition

Cardiometabolic biomarkers

Renal / kidney

Patient-reported / QoL

Weight & body composition

3 endpoints

Secondary/protocol endpoint

Weight Change

Time frame:Baseline, 6 months, 18 months

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

BMI Change

Time frame:Baseline, 6 months, 18 months

BMI, change

change from baseline, improvement

Secondary/protocol endpoint

Waist circumference change

Time frame:Baseline, 6 months, 18 months

Waist circumference, change

change from baseline, improvement

Glycemic / diabetes

6 endpoints

Primary/protocol endpoint

Hba1c change

Time frame:6 months, 9 months, 12 months

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Primary/protocol endpoint

Proportions of patients with significant HbA1c change

Time frame:Baseline, 3 months, 6 months, 9 months, 12 months, 18 months

HbA1c, change

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Fasting glycemia change

Time frame:Baseline, 6 months, 18 months

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Post-prandial glycemia change

Time frame:Baseline, 6 months, 18 months

Postprandial glucose

change from baseline, improvement

Secondary/protocol endpoint

C-peptide change

Time frame:Baseline, 6 months, 18 months

C-peptide AUC

change from baseline, improvement

Secondary/protocol endpoint

Change in total daily insulin dose

Time frame:Baseline, 6 months, 18 months

change from baseline, improvement

Renal / kidney

1 endpoint

Secondary/protocol endpoint

Change in eGFR

Time frame:Baseline, 6 months, 18 months

eGFR, change

change from baseline, improvement

LOINC 98979-8

Cardiometabolic biomarkers

2 endpoints

Secondary/protocol endpoint

Blood pressure change

Time frame:Baseline, 6 months, 18 months

change from baseline, improvement

Secondary/protocol endpoint

Change in lipide profile

Time frame:Baseline, 6 months, 18 months

change from baseline, improvement

Patient-reported / QoL

1 endpoint

Secondary/protocol endpoint

Diabetes treatment satisfaction

Time frame:Baseline, 6 months, 18 months

change from baseline, improvement

Publications (3)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

BEYOND 2 years: durability of metabolic benefits by simplification of complex insulin regimens in type 2 diabetes.
Endocrine2024 Feb (month)PMID37787888doi:10.1007/s12020-023-03547-9via clinicaltrials gov reference derived + pubmed nct search
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 care2021 Jun (month)PMID33883195doi:10.2337/dc20-2623via clinicaltrials gov reference derived + pubmed nct search
Beyond basal-bolus insulin regimen: Is it still the ultimate chance for therapy in diabetes?
Diabetes research and clinical practice2019 Nov (month)PMID31715201doi:10.1016/j.diabres.2019.107922via CT.gov background

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.