Diabetes Mellitus
Conditions
Keywords
semaglutide, real world study, obesity, type II diabetes, Argentinian Society of Medicine
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).
Interventions
DRUGsemaglutide
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.
Sponsors
Hospital Italiano de Buenos Aires
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in glycated hemoglobin (HbA1c) levels from baseline to 3, 6, and 12 months of follow-up. | Baseline, 3 months, 6 months, and 12 months. | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Body Weight | Baseline, 3 months, 6 months, and 12 months. | Mean change in body weight (kg) compared with baseline. |
| Change in Waist Circumference | Baseline, 3 months, 6 months, and 12 months. | Mean change in waist circumference (cm) compared with baseline. |
| Change in Hand-Grip Strength | Baseline, 3 months, 6 months, and 12 months. | Mean change in grip strength (kg) measured with a hand dynamometer. |
| Treatment Satisfaction Assessed With the Diabetes Treatment Satisfaction Questionnaire | Baseline, 3 months, 6 months, and 12 months. | 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. |
| Treatment Adherence Assessed With the Simplified Medication Adherence Questionnaire | Baseline, 3 months, 6 months, and 12 months. | 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. |
| Proportion of Patients Switching Administration Route | Up to 12 months. | Percentage of participants switching between oral and subcutaneous semaglutide, including direction and reason for change. |
| Reasons for Treatment Discontinuation | Up to 12 months. | Frequency and type of reasons for discontinuation (adverse events, inefficacy, patient decision, etc.). |
| Adverse Events | Up to 12 months. | Incidence and severity of adverse events, categorized by system organ class and relationship to semaglutide. |
Countries
Argentina
Contacts
CONTACTMartín L Gil Folgar, MD
CONTACTNatalia Nachón, MD
PRINCIPAL_INVESTIGATORMaría Natalia Nachón, MD
Hospital General de Agudos Dr Enrique Tornú
STUDY_DIRECTORIván A Huespe, MD
Hospital Italiano de Buenos Aires
STUDY_CHAIRMatías Mirofsky, MD
Hospital Leónidas Lucero, Bahía Blanca
Outcome results
None listed