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.