Semaglutide Form Comparison in Type 2 Diabetes Management: A 12-month Real-world Study on Sex-related Outcomes
This study observes how type 2 diabetes is managed with different forms of Semaglutide, oral and subcutaneous, in a real-world setting over 12 months, focusing on HbA1c changes and sex-related outcomes.
Data Collection
Collected from today forward - ProspectiveDiabetes Mellitus+3
+ Diabetes Mellitus, Type 2
+ Endocrine System Diseases
Cohort
Tracking disease incidence in order to identify risk factors and understand disease progression over time.Summary
Study start date: January 1, 2024
Actual date on which the first participant was enrolled.This study is focused on comparing two forms of a medication called semaglutide, which is used to treat type 2 diabetes. The medication can be taken as a pill or given as an injection. The research is particularly interested in seeing if men and women respond differently to these two forms over a year. The study aims to find out which form might work better for controlling blood sugar levels and other health factors like weight and liver health. This information could help doctors make better treatment decisions for men and women with type 2 diabetes, tailoring treatments to individual needs based on sex-specific responses. In this study, 212 adults with type 2 diabetes, who have not used this type of medication before, are divided into two groups. One group takes the oral form of semaglutide, starting with a low dose that may increase if needed, while the other group receives weekly injections with a similar dosing plan. Over 12 months, researchers check the participants' blood sugar levels, body weight, and other health markers to see any differences between the two groups. The study also considers the presence of diabetes-related complications like eye or kidney problems. By the end of the study, results indicate that the injectable form may lead to better outcomes in men regarding weight and blood sugar control, while women might experience more liver-related benefits. This research could lead to more personalized diabetes care based on whether the patient is male or female.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.212 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Cohort
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Exclusion criteria: * pregnancy * known allergy or hypersensitivity to semaglutide * participation in another clinical trial during the treatment period Inclusion criteria: * age over 18 years * diagnosis of T2D at least one year before the recruitment * no treatment with prior GLP-1 RA * baseline HbA1c \>6.5% (48 mmol/mol)
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location