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Trial · Observational

RecruitingPhase not statedRegistry data

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

Short name SEMA-REAL ARG

NCTNCT07621419 (opens ClinicalTrials.gov in a new tab)Other id15820
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Recruiting
Phase
Phase not stated
Enrollment
145 participants (estimated)
Sponsor
Hospital Italiano de Buenos Aires · Other
Design
Not stated
Countries
1 country

Argentina

Start
4 Aug 2025
Primary completion
31 Dec 2027 (estimated)
Completion
31 Dec 2028 (estimated)
First posted
2 Jun 2026
Last update posted
2 Jun 2026
Conditions
Diabetes Mellitus

Timeline

1 trial · 1 ongoing

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20252026202720282029
  1. Ph –

    SEMA-REAL ARG

    NCT07621419

    4 Aug 2025 to est. 31 Dec 2028

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The goal of this prospective, multicenter, observational study is to evaluate the real-world effectiveness and safety of oral and subcutaneous semaglutide in adults with type 2 diabetes mellitus in Argentina. The main objective is to assess changes in glycated hemoglobin (HbA1c) from baseline to 3, 6, and 12 months after treatment initiation. Secondary objectives include evaluating changes in body weight, waist circumference, hand-grip strength, treatment satisfaction, medication adherence, treatment route switching, treatment discontinuation, and adverse events. Participants will receive semaglutide as prescribed by their treating physician as part of routine clinical care. Follow-up assessments will be performed at 3, 6, and 12 months to collect clinical, laboratory, safety, treatment satisfaction, and adherence data. Treatment satisfaction will be assessed using the Diabetes Treatment Satisfaction Questionnaire (DTSQ), and adherence will be assessed using the Simplified Medication Adherence Questionnaire (SMAQ).

Interventions

  • semaglutideDrug

Arms1

  • Other

    Patients with Type 2 Diabetes Treated with Semaglutide (Oral or Subcutaneous)

    This cohort includes adults aged 18 years or older with type 2 diabetes mellitus who initiate treatment with oral or subcutaneous semaglutide as prescribed by their treating physician in routine clinical practice. The study is observational and does not assign treatment. Dose, formulation, and route of administration are determined by the treating physician according to standard care.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. 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.

    Registry description

    Mean change in HbA1c (%) compared with baseline among adult patients with type 2 diabetes treated with oral or subcutaneous semaglutide in real-world clinical practice.

Secondary outcomes(8)

  1. Change in Body Weight

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

    Registry description

    Mean change in body weight (kg) compared with baseline.

  2. Change in Waist Circumference

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

    Registry description

    Mean change in waist circumference (cm) compared with baseline.

  3. Change in Hand-Grip Strength

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

    Registry description

    Mean change in grip strength (kg) measured with a hand dynamometer.

  4. Treatment Satisfaction Assessed With the Diabetes Treatment Satisfaction Questionnaire

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

    Registry description

    Change from baseline in treatment satisfaction assessed using the Diabetes Treatment Satisfaction Questionnaire. The total treatment satisfaction score ranges from 0 to 36, with higher scores indicating greater treatment satisfaction.

  5. Treatment Adherence Assessed With the Simplified Medication Adherence Questionnaire

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

    Registry description

    Proportion of participants classified as adherent according to the Simplified Medication Adherence Questionnaire. Participants will be classified as adherent or non-adherent according to the questionnaire scoring rules.

  6. Proportion of Patients Switching Administration Route

    Time frame · Up to 12 months.

    Registry description

    Percentage of participants switching between oral and subcutaneous semaglutide, including direction and reason for change.

  7. Reasons for Treatment Discontinuation

    Time frame · Up to 12 months.

    Registry description

    Frequency and type of reasons for discontinuation (adverse events, inefficacy, patient decision, etc.).

  8. Adverse Events

    Time frame · Up to 12 months.

    Registry description

    Incidence and severity of adverse events, categorized by system organ class and relationship to semaglutide.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies3

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Clinical trial · 2024

9 results

PIONEER REAL UK: A Multi-Centre, Prospective, Real-World Study of Once-Daily Oral Semaglutide Use in Adults with Type 2 Diabetes.

Saravanan et al. 2024Advances in therapycited by 9

PMID 39316289PMC11480173DOI 10.1007/s12325-024-02973-zPUB-39316289

Free to read · publisher termsCC BY-NC9 results
Read at sourceSee results (9)

More studies

2 studies on this page

Indexing hint: Review · 2022

Semaglutide, a glucagon like peptide-1 receptor agonist with cardiovascular benefits for management of type 2 diabetes.

Mahapatra et al. 2022Reviews in endocrine & metabolic disorderscited by 107

PMID 34993760PMC8736331DOI 10.1007/s11154-021-09699-1PUB-34993760

Rights unknown
Source link

PubMed tag: none · 2019

PIONEER 1: Randomized Clinical Trial of the Efficacy and Safety of Oral Semaglutide Monotherapy in Comparison With Placebo in Patients With Type 2 Diabetes.

Aroda et al. 2019Diabetes carecited by 388

PMID 31186300DOI 10.2337/dc19-0749PUB-31186300

Full text at the publisher
Publisher page

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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.

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