SEMA-REAL ARG

Recruiting

Study of Adult Patients Residing in Argentina Diagnosed With Type 2 Diabetes Treated With a New Formulation of Semaglutide, Both Oral and Subcutaneous, in a Real-world Setting at 3 Months, 6 Months, and 1 Year of Follow-up, Quantifying the Reduction in Glycated Hemoglobin

New Formulation of Semaglutide in the Treatment of Type 2 Diabetes in Argentina: a Prospective, Multicenter, Real-world Study

Lead sponsor

Hospital Italiano de Buenos Aires

Asset

Semaglutide

Oral · GLP-1 agonist

Listed sites

Recruiting sites

Enrollment

145

estimated

Study population

Type 2 diabetes

Key I/E criterion

•HbA1c 7-12%

Primary endpoint

•Glycated hemoglobin (HbA1c) levels from baseline to 3, 6

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 IDNCT07621419

Org study ID15820

Timeline

Milestones

Study start2025-08-04actual

Study first posted2026-06-02actual

Last update posted2026-06-02actual

Primary completion2027-12-31estimated

Study completion2028-12-31estimated

Assets

Investigational agents

Semaglutide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

Sampling methodNon probability sample

Study population text

Study participants will be selected from adult patients with type 2 diabetes receiving routine medical care at outpatient endocrinology and internal medicine clinics across multiple centers in Argentina.

Inclusion criteria

•Age ≥ 18 years.

•Clinical diagnosis of type 2 diabetes mellitus.

•Baseline glycated hemoglobin (HbA1c) >7% and ≤12%.

•Initiating treatment with semaglutide (oral or subcutaneous) prescribed by the treating physician according to clinical judgment.

Exclusion criteria

•Pregnancy or lactation at the time of enrollment.

•History of severe hypersensitivity or adverse reactions to glucagon-like peptide-1 (GLP-1) receptor agonists.

•Contraindications to semaglutide as listed in the product label (e.g., severe gastrointestinal disease, certain endocrine tumors).

•Any other serious medical condition that, in the investigator's opinion, may interfere with study participation or data interpretation.

Endpoints (11)

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

Other (unclassified)

Weight & body composition

Glycemic / diabetes

Patient-reported / QoL

Safety / tolerability / PK

Weight & body composition

2 endpoints

Secondary/protocol endpoint

Change in Body Weight

Time frame:Baseline, 3 months, 6 months, and 12 months.

change from baseline, improvement

Secondary/protocol endpoint

Change in Waist Circumference

Time frame:Baseline, 3 months, 6 months, and 12 months.

change from baseline, improvement

Glycemic / diabetes

2 endpoints

Primary/protocol endpoint

Change in glycated hemoglobin (HbA1c) levels from baseline to 3, 6, and 12 months of follow-up.

Time frame:Baseline, 3 months, 6 months, and 12 months.

change from baseline, improvement

Secondary/protocol endpoint

Treatment Satisfaction Assessed With the Diabetes Treatment Satisfaction Questionnaire

Time frame:Baseline, 3 months, 6 months, and 12 months.

descriptive

Patient-reported / QoL

1 endpoint

Secondary/protocol endpoint

Treatment Adherence Assessed With the Simplified Medication Adherence Questionnaire

Time frame:Baseline, 3 months, 6 months, and 12 months.

descriptive

Safety / tolerability / PK

1 endpoint

Secondary/protocol endpoint

Adverse Events

Time frame:Up to 12 months.

descriptive

Other (unclassified)

5 endpoints

Secondary/protocol endpoint/low confidence

Change in Hand-Grip Strength

Time frame:Baseline, 3 months, 6 months, and 12 months.

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Proportion of Patients Switching Administration Route

Time frame:Up to 12 months.

threshold achievement, improvement

Secondary/protocol endpoint/low confidence

Reasons for Treatment Discontinuation

Time frame:Up to 12 months.

descriptive

Other/protocol endpoint/low confidence

Change in Semaglutide Dose Over Time

Time frame:Baseline, 3 months, 6 months, and 12 months.

change from baseline, improvement

Other/protocol endpoint/low confidence

Subgroup Analysis by Administration Route

Time frame:Up to 12 months.

ratio, improvement

Publications (7)

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

Utilizing Secondary Data from Electronic Health Records for Automated Frailty Detection in Older Adults with Diabetes.
Studies in health technology and informatics2025 Aug 7PMID40775843doi:10.3233/SHTI250825via CT.gov background
9. Pharmacologic Approaches to Glycemic Treatment: Standards of Care in Diabetes-2025.
Diabetes care2025 Jan 1PMID39651989doi:10.2337/dc25-S009via CT.gov background
PIONEER REAL UK: A Multi-Centre, Prospective, Real-World Study of Once-Daily Oral Semaglutide Use in Adults with Type 2 Diabetes.
Advances in therapy2024 Nov (month)PMID39316289doi:10.1007/s12325-024-02973-zvia CT.gov background
Socioeconomic Inequalities in the Prevalence of Diabetes in Argentina: A Repeated Cross-Sectional Study in Urban Women and Men.
International journal of environmental research and public health2022 Jul 22PMID35897259doi:10.3390/ijerph19158888via CT.gov background
Semaglutide, a glucagon like peptide-1 receptor agonist with cardiovascular benefits for management of type 2 diabetes.
Reviews in endocrine & metabolic disorders2022 Jun (month)PMID34993760doi:10.1007/s11154-021-09699-1via CT.gov background
PIONEER 1: Randomized Clinical Trial of the Efficacy and Safety of Oral Semaglutide Monotherapy in Comparison With Placebo in Patients With Type 2 Diabetes.
Diabetes care2019 Sep (month)PMID31186300doi:10.2337/dc19-0749via CT.gov background
Validation of a simplified medication adherence questionnaire in a large cohort of HIV-infected patients: the GEEMA Study.
AIDS (London, England)2002 Mar 8PMID11873004doi:10.1097/00002030-200203080-00012via 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.