Type 2 Diabetes (T2D) Clinical Trials

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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Observational
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Argentina
Hospital General de Agudos Dr Enrique Tornú
RECRUITING
Buenos Aires
Hospital Italiano de Buenos Aires
RECRUITING
Buenos Aires
Contact Information
Primary
Martín L Gil Folgar, MD
martin.gilfolgar@hospitalitaliano.org.ar
1520497361
Backup
Natalia Nachón, MD
dra.nachon@gmail.com
155876-3407
Time Frame
Start Date: 2025-08-04
Estimated Completion Date: 2028-12-31
Participants
Target number of participants: 145
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Hospital Italiano de Buenos Aires

This content was sourced from clinicaltrials.gov