Project Description

Author: Amin et al.

Summary:

The escalating global prevalence of type 2 diabetes mellitus (T2DM) with its associated healthcare burden necessitate the innovation of effective and adaptable treatment approaches. Omarigliptin, a once-weekly dipeptidyl peptidase-4 (DPP-4) inhibitor, has been demonstrated with promising outcomes in the management of T2DM in clinical trials conducted across the world. This study aims to assess the real-world effectiveness and safety of omarigliptin in the management of newly diagnosed T2DM clinical settings in Bangladesh. This observational study will be conducted at BIRDEM General Hospital in Bangladesh over a period of 12 months. Individuals aged 18 years or older who have recently diagnosed with T2DM with no history of prior anti diabetic medication were approached for this study. A total of 938 patients meeting specific inclusion and exclusion criteria will be enrolled after obtaining informed written consent. Each patient will receive personalized antidiabetic treatment (with or without omarigliptin) prescribed by their respective physicians, in addition to standard dietary and exercise recommendations. All patients will be categorized by the use of omarigliptin. After enrollment, each patient will be subjected to face to face interview, physical examinations, and laboratory assessments. Data on socio-demographic characteristics, medical histories, clinical presentations, and investigative findings will be meticulously recorded in seperated case record forms. Patients will be followed up thrice: 14 days after enrollment, at 3 month of enrollment, and at the 6-month of enrollment. The efficacy of omarigliptin in glycemic control will be evaluated by measuring HbA1C serum levels, fasting plasma glucose, and the proportion of patients achieving glycemic targets. Safety assessments will include monitoring for adverse events. The study will adhere to ethical standards by the ‘Declaration of Helsinki’. Data analysis will be conducted using SPSS Version 23.

Keywords: Omarigliptin, T2DM, Type 2 Diabetes Mellitus, DPP-4 inhibitor, Real world evidence, Bangladesh

Status: Ongoing

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