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

NCT07621419 | Recruiting FDA Drug

• 1 other identifier: 15820
• Study Type: observational
• Target: 145
• Locations: 1 country
• Sites: 2

Brief Summary

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).

Conditions

Diabetes Mellitus

Keywords

semaglutide; real world study; obesity; type II diabetes; Argentinian Society of Medicine

Outcome Measures

Primary Outcomes (1)

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

  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.

  Baseline, 3 months, 6 months, and 12 months.

Secondary Outcomes (8)

• Change in Body Weight

  Baseline, 3 months, 6 months, and 12 months.

• Change in Waist Circumference

  Baseline, 3 months, 6 months, and 12 months.

• Change in Hand-Grip Strength

  Baseline, 3 months, 6 months, and 12 months.

• Treatment Satisfaction Assessed With the Diabetes Treatment Satisfaction Questionnaire

  Baseline, 3 months, 6 months, and 12 months.

• Treatment Adherence Assessed With the Simplified Medication Adherence Questionnaire

  Baseline, 3 months, 6 months, and 12 months.

Other Outcomes (2)

• Change in Semaglutide Dose Over Time

  Baseline, 3 months, 6 months, and 12 months.

• Subgroup Analysis by Administration Route

  Up to 12 months.

Study Arms (1)

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.

Drug: semaglutide

Interventions

semaglutide DRUG

Participants will receive semaglutide as part of their usual medical care for type 2 diabetes mellitus. The intervention of interest includes both oral and subcutaneous formulations of semaglutide, prescribed and dosed at the discretion of the treating physician according to routine clinical practice.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Italiano de Buenos Aires: lead

Study Sites (2)

Hospital Italiano de Buenos Aires

Buenos Aires, Buenos Aires, 1199, Argentina

RECRUITING

Hospital General de Agudos Dr Enrique Tornú

Buenos Aires, Buenos Aires, 1427, Argentina

RECRUITING

Related Publications (7)

• Knobel H, Alonso J, Casado JL, Collazos J, Gonzalez J, Ruiz I, Kindelan JM, Carmona A, Juega J, Ocampo A; GEEMA Study Group. Validation of a simplified medication adherence questionnaire in a large cohort of HIV-infected patients: the GEEMA Study. AIDS. 2002 Mar 8;16(4):605-13. doi: 10.1097/00002030-200203080-00012.

  PMID: 11873004 BACKGROUND

• Rojas-Roque C, Hernandez-Vasquez A, Azanedo D, Bendezu-Quispe G. Socioeconomic Inequalities in the Prevalence of Diabetes in Argentina: A Repeated Cross-Sectional Study in Urban Women and Men. Int J Environ Res Public Health. 2022 Jul 22;19(15):8888. doi: 10.3390/ijerph19158888.

  PMID: 35897259 BACKGROUND

• Burgos MA, Morales Mendez EJ, Russo MP, Martingano I, Lopez Gutierrez MP, Maccio AM, Segalini A, Plazzotta F, Otero C, Orrego N, Grande Ratti MF. Utilizing Secondary Data from Electronic Health Records for Automated Frailty Detection in Older Adults with Diabetes. Stud Health Technol Inform. 2025 Aug 7;329:179-183. doi: 10.3233/SHTI250825.

  PMID: 40775843 BACKGROUND

• American Diabetes Association Professional Practice Committee. 9. Pharmacologic Approaches to Glycemic Treatment: Standards of Care in Diabetes-2025. Diabetes Care. 2025 Jan 1;48(1 Suppl 1):S181-S206. doi: 10.2337/dc25-S009.

  PMID: 39651989 BACKGROUND

• Saravanan P, Bell H, Braae UC, Collins E, Deinega A, Dhatariya K, Machell A, Trent A, Strzelecka A. PIONEER REAL UK: A Multi-Centre, Prospective, Real-World Study of Once-Daily Oral Semaglutide Use in Adults with Type 2 Diabetes. Adv Ther. 2024 Nov;41(11):4266-4281. doi: 10.1007/s12325-024-02973-z. Epub 2024 Sep 24.

  PMID: 39316289 BACKGROUND

• Aroda VR, Rosenstock J, Terauchi Y, Altuntas Y, Lalic NM, Morales Villegas EC, Jeppesen OK, Christiansen E, Hertz CL, Haluzik M; PIONEER 1 Investigators. 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 Care. 2019 Sep;42(9):1724-1732. doi: 10.2337/dc19-0749. Epub 2019 Jun 11.

  PMID: 31186300 BACKGROUND

• Mahapatra MK, Karuppasamy M, Sahoo BM. Semaglutide, a glucagon like peptide-1 receptor agonist with cardiovascular benefits for management of type 2 diabetes. Rev Endocr Metab Disord. 2022 Jun;23(3):521-539. doi: 10.1007/s11154-021-09699-1. Epub 2022 Jan 7.

  PMID: 34993760 BACKGROUND

Related Links

• Statistics on the prevalence of diabetes, obesity, and related risk factors in Argentina based on national health surveys conducted by the Instituto Nacional de Estadística y Censos (INDEC).

MeSH Terms

Conditions

Diabetes Mellitus; Obesity; Diabetes Mellitus, Type 2

Interventions

semaglutide

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• María Natalia Nachón, MD

  Hospital General de Agudos Dr Enrique Tornú

  PRINCIPAL INVESTIGATOR

• Iván A Huespe, MD

  Hospital Italiano de Buenos Aires

  STUDY DIRECTOR

• Matías Mirofsky, MD

  Hospital Leónidas Lucero, Bahía Blanca

  STUDY CHAIR

Central Study Contacts

Martín L Gil Folgar, MD

CONTACT

1520497361; martin.gilfolgar@hospitalitaliano.org.ar

Natalia Nachón, MD

CONTACT

155876-3407; dra.nachon@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Research ICU

Study Record Dates

• First Submitted: May 19, 2026
• First Posted: June 2, 2026
• Study Start: August 4, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: June 2, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

AR (2)