Real-world effectiveness, safety, and quality of life of biosynthetic semaglutide in Pakistani adults with type 2 diabetes mellitus: a study protocol
Abstract
Introduction Type 2 diabetes (T2D) is a critical public health crisis in Pakistan, which currently holds the highest age-standardised prevalence globally. While semaglutide significantly improves glycemic control and weight, high costs limit access to the innovator molecule in low – and middle-income countries. Biosynthetic semaglutide provides an affordable local alternative, yet real-world evidence regarding its clinical performance and impact on quality of life (QoL) is currently lacking.Methods and analysis The BIOSURE study is a 30-week, multicenter, prospective, non-interventional, single-arm observational protocol evaluating biosynthetic semaglutide in 268 adults with T2D across Pakistan. The primary objective is to quantify the absolute change in glycated hemoglobine (HbA1c) from baseline to 30 weeks. Secondary objectives include assessing changes in body weight, waist circumference, blood pressure, lipid profiles, and safety. Patient-centered outcomes will be measured via the Diabetes Treatment Satisfaction Questionnaire, Morisky Medication Adherence Scale, and SF-36v2 health survey. Statistical analysis will utilise mixed-effects modelling and multiple imputation for missing data.Ethics and dissemination Ethical approval has been obtained from the USM Human Research Ethics Committee and local IRBs. The study is registered with the ANZCTR (ACTRN12625000610437). Findings will be disseminated through peer-reviewed journals and policy forums to provide a clinical and assistive framework for scalable diabetes care in resource-constrained settings.Trial registration: Australian New Zealand Clinical Trials Registry identifier: ACTRN12625000610437.
What are the key findings of this study?
Biosynthetic semaglutide is a new, affordable medicine for managing type 2 diabetes. It's being tested to see how well it improves blood sugar levels and quality of life for adults in Pakistan. This study plans to check how much it can lower blood sugar and if it helps people feel better overall. This is important because it could make diabetes care easier for many people. 🌟
Key Points
Objective
To evaluate the real-world effectiveness of biosynthetic semaglutide in improving glycemic control and quality of life in adults with type 2 diabetes.