PDB89 - A Multivariate analysis of Prescribing Information for Next Generation type 2 Diabetes treatments

Abstract

To compare the pivotal clinical endpoints on the prescribing information labels of next generation treatments for type 2 diabetes (T2D) and to identify the most clinically-relevant antidiabetic outcomes. This multivariate analysis was designed to identify the appropriate treatment paradigm for the management of patients with T2D, based on symptomatology and relative efficacy. A multivariate analysis of clinical efficacy endpoints from product information labels of 10 recently approved next generation treatments for adult T2D was undertaken, with 26-week, placebo-controlled endpoint data for utilized all compounds, including change from baseline in hemoglobin A1c (%), body weight (kg), fasting plasma glucose (mg/dL), post-prandial plasma glucose (mg/dL), and the incidence of hypoglycemic events (%). Clinical relevance for this analysis was defined as 1% reduction in HbA1c, 5kg reduction in mean body weight from baseline, and an incidence of hypoglycemia <1%. Data with metformin in combination therapy was included where available, based on current therapeutic guidelines. The multivariate analysis highlighted that no single compound met the predefined hypothesis of clinical relevance after 26-weeks of treatment. Canagliflozin 300mg / metformin (-1.06%) and liraglutide (-1.00%) reported the greatest reduction in HbA1c. Canagliflozin 300mg / metformin (-4.07kg) and dapaglaflozin 10mg / metformin (-2.86kg) had the greatest mean reduction in body weight from baseline. Linagliptin 5mg / metformin (0.60%) and dapaglaflozin 10mg / metformin (1.10%) had the lowest incidence of hypoglycemia. Physicians should consider all clinically-relevant outcomes of available T2D therapies with individual patient needs before initiating treatment. Clinicians must be aware of the various clinical outcomes for available therapies to ensure a safe and effective treatment regimen based on the symptomatic profile of individual patients. A triple-goal targeted approach to the management of T2D may reduce healthcare costs and treatment augmentation while improving quality of life for patients.