Positive results from the T2NOW Phase III trial demonstrated significant reduction in A1C, a marker of average blood sugar, for patients treated with Forxiga (dapagliflozin) compared with patients receiving placebo.1,2 Adjusted mean change in A1C was −0.62% for Forxiga versus +0.41% for placebo, a difference of −1.03% (95% CI: -1.57-0.49; pForxiga can provide clinically meaningful improvements in glycemia for children and adolescents with type 2 diabetes (T2D).1 The safety results in this patient population were consistent with those in adults with T2D, in line with the well-established safety profile for Forxiga.1
Naim Shehadeh, Professor of Endocrinology, Rambam Health Care Campus, Israel, said: "The significant decrease in A1C that we observed in patients receiving Forxiga may indicate a reduction in the progression of disease and its complications. This is an important treatment consideration as children and adolescents with type 2 diabetes often experience earlier onset of complications and faster advancement of disease compared to adults with the same condition."
Ruud Dobber, Executive Vice President, BioPharmaceuticals Business Unit, AstraZeneca, said: "Today's results from one of the largest studies into children suffering from type 2 diabetes, offers hope. Despite the growing global burden of type 2 diabetes among children and adolescents, the treatment options available are currently limited. It is well documented that some patients find injectable therapies challenging, making the need for effective oral treatment alternatives paramount."
Results were presented today at the 59th Annual Meeting of the European Association for the Study of Diabetes (EASD) Congress and simultaneously published in The New England Journal of Medicine Evidence.1
The incidence and prevalence of T2D in children and adolescents are increasing globally.3 In 2021, it was estimated that there were approximately 41,600 new cases diagnosed worldwide.3
Notes
T2D
T2D is a chronic disease characterised by pathophysiologic defects leading to elevated glucose levels, or hyperglycaemia.4 Over time, this sustained hyperglycaemia contributes to further progression of the disease.4 The prevalence of diabetes is projected to reach 783 million by 2045.4 T2D is the most common type of diabetes, accounting for over 90% of all diabetes worldwide.5 Significant unmet medical need still exists, as many patients have poor blood sugar control and low medication adherence.4,6
T2NOW
T2NOW was a randomised, double-blind, placebo-controlled Phase III trial designed to evaluate the efficacy and safety of dapagliflozin as add-on treatment in children and adolescents with T2D receiving metformin, insulin or both.7 Patients were randomised to dapagliflozin, saxagliptin or placebo.7 Those receiving an active drug were further randomised to continue their current dose, or up-titrate to a higher dose of the same active treatment.7 The primary endpoint was change in A1C after 26 weeks vs placebo for dapagliflozin (5 or 10 mg) or saxagliptin (2.5 or 5 mg).7 Secondary endpoints included change in fasting plasma glucose and proportion of patients (A1C ≥7% at baseline) achieving A1C 7
Forxiga
Forxiga (dapagliflozin) is a first-in-class, oral, once-daily sodium-glucose cotransporter 2 (SGLT2) inhibitor. Research has shown Forxiga's efficacy in preventing and delaying cardiorenal disease, while also protecting the organs - important findings given the underlying links between the heart, kidneys and pancreas.8-10 Damage to one of these organs can cause the other organs to fail, contributing to leading causes of death worldwide, including T2D, heart failure (HF) and chronic kidney disease (CKD).11-14
As of August 2023, Forxiga was approved in 122 countries as an adjunct to diet and exercise to improve glycaemic control in adults with T2D. Forxiga is approved for paediatric patients aged 10 years and above with T2D in the EU and other countries based on the T2GO study.15,16Forxiga is currently not approved for use in paediatric patients with T2D in the US.
In addition, Forxiga is approved for the treatment of heart failure with reduced ejection fraction (HFrEF) and chronic kidney disease (CKD) in more than 100 countries around the world. It has most recently received regulatory approvals across major geographies to extend the heart failure indication to include patients across the full left ventricular ejection fraction range.
AstraZeneca in CVRM
Cardiovascular, Renal and Metabolism (CVRM), part of BioPharmaceuticals, forms one of AstraZeneca's main disease areas and is a key growth driver for the Company. By following the science to understand more clearly the underlying links between the heart, kidneys, liver and pancreas, AstraZeneca is investing in a portfolio of medicines for organ protection by slowing or stopping disease progression, and ultimately paving the way towards regenerative therapies. The Company's ambition is to improve and save the lives of millions of people, by better understanding the interconnections between CVRM diseases and targeting the mechanisms that drive them, so we can detect, diagnose and treat people earlier and more effectively.
AstraZeneca
AstraZeneca (LSE/STO/Nasdaq: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialisation of prescription medicines in Oncology, Rare Diseases, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. Please visit astrazeneca.com and follow the Company on social media @AstraZeneca
