Diabetes Clinical Trials: Innovations Driving Progress
On November 14th, Medpace joins the global community in recognizing World Diabetes Day, a critical reminder of the growing impact of this chronic disease. Despite years of clinical progress, diabetes continues to pose significant health challenges, with the IDF Diabetes Atlas (2021) reporting that 10.5% of the adult population (20-79 years) has diabetes, with projections showing that 1 in 8 adults will be living with diabetes by 2045.
To overcome these health challenges, recent innovations are reshaping how we manage, monitor, and treat diabetes. In this edition of our newsletter, we explore key trends driving breakthroughs in diabetes clinical research.
Continuous Glucose Monitoring (CGM)
Continuous glucose monitors have transformed diabetes management, providing real-time insights and augmenting traditional glucose testing in everyday scenarios. However, some clinical trials have yet to fully adopt CGM technology, and often still require burdensome finger-prick tests. Integrating CGMs into clinical trials can improve data quality, enhance participant experience, and reduce compliance issues, allowing patients to seamlessly engage with the study without disrupting their lives.
CGM use has been shown to improve time in range (TIR) while reducing both hyperglycemia and hypoglycemia, including nighttime episodes, in individuals with type 1 and type 2 diabetes. As CGM adoption grows, these devices are increasingly integrated into clinical trials to capture detailed glucose profiles and enable more precise measurement of glycemic outcomes. Explore key considerations for implementing CGM in clinical trials with an eye on regulatory guidance in the recently published article, “Maximizing the Potential of Continuous Glucose Monitoring in Clinical Trials."
GLP-1 and GLP-1/GIP Receptor Agonists
Originally developed to help regulate glucose levels, GLP-1 receptor agonists, such as semaglutide and dulaglutide, and the dual GLP-1/GIP receptor agonist, tirzepatide, are now recognized for their broader benefits. These medications not only improve glycemic control but also promote significant weight loss, offering multiple advantages for patients with type 2 diabetes and obesity.
Novel anti-obesity medications were prominently discussed this year at key conferences, including the European Congress on Obesity, American Diabetes Association's Scientific Sessions, and ENDO 2024. Various combinations of GLP-1, GIP, and glucagon agonists or antagonists are currently under clinical development, including weekly or monthly injectable and oral formulations. The presentations at these conferences highlighted their weight reduction effects, which may be as prominent as almost a quarter of body weight loss within a year. Additional focus has been placed on other direct and indirect beneficial effects, such as reducing cardio-renal-metabolic risks associated with obesity. As GLP-1 and GLP-1/GIP therapies expand in clinical use, clinical trials are focusing on optimizing dosing regimens and evaluating long-term outcomes in diverse populations.
Cardiovascular Outcomes Trials (CVOTs)
An FDA guidance in 2020 removed the previous recommendation to evaluate the cardiovascular safety of glucose-lowering drugs since several rigorous CVOTs with DPP4i, SGLT2i, and GLP-1s showed no increased risk of ischemic cardiovascular events. However, evaluating the impact of diabetes treatments on heart health remains crucial with the focus on enrolling clinical trial participants with type 2 diabetes who also have cardiovascular disease, chronic kidney disease, and are older (>65 years of age), to understand the broader impact of therapies. These trials will continue to guide the development of treatments that address metabolic, renal, and cardiovascular health.
Your Diabetes Breakthrough Starts Here
With a successful track record of approvable NDA submissions, deep therapeutic expertise and decades of experience, Medpace can successfully navigate the operational complexities and regulatory scrutiny that endocrine and metabolic development programs often face. We have experience in recruiting historically difficult and highly competitive patient populations (both adult and pediatric), including patients with type 1 and type 2 diabetes.
At Medpace, we understand that patient engagement in diabetes trials can be challenging, with factors such as long study durations, glucose monitoring requirements, and complex drug regimens contributing to patient drop-out. Our team has the knowledge and tools to implement retention strategies that help mitigate these risks, ensuring studies run smoothly and generate high-quality data.
In the case study, “Strategies to Accelerate Enrollment Timelines for Trials in Commonly Spread Diseases,” discover how Medpace accelerated site selection and patient recruitment to help our Sponsor meet enrollment timelines in a recent Phase 2 trial for type 2 diabetes.
In recognition of World Diabetes Day, we invite you to hear more from our global team of operational and medical experts. To learn more, visit our website today.
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Clinical Research Coordinator | Clinical Data Management
1 周Very insighful read, particularly the CVOT's.
Clinical Research Coordinator | Clinical Data Management
1 周I enjoyed reading your article, Medpace’s. Great job! The section on Cardiovascular Outcomes Trials (CVOTs) was especially insightful, showing how updated FDA guidance and recent CVOTs have improved understanding of cardiovascular safety in diabetes treatments. It emphasized the importance of monitoring heart health in type 2 diabetes patients, especially those with cardiovascular and kidney issues.
Senior Clinical Research Associate | Bachelor of Business Administration
1 周Good job Medpace, for spotlighting World Diabetes Day. With diabetes cases on the rise, continued efforts in research and accessible treatments are more essential than ever. Here’s to advancing solutions for prevention, management, and a healthier future.
University of Cincinnati Alumni ‘24 Bachelor of Science in Marketing and Professional Selling
1 周As a Type 1 Diabetic, thank you for bringing attention to this matter. This post was extremely insightful and informative!