FDA Proposes Broad Approach to Clinical Trials for Diabetes Drugs

The FDA issued a new draft guidance evaluating the safety of two new drugs for type 2 diabetes and removing the previous requirement for standardized clinical trials for diabetes drugs. 

The draft guidance, “Type 2 Diabetes Mellitus: Evaluating the Safety of New Drugs for Improving Glycemic Control,” proposed a broader safety evaluation approach before drug approval beyond ischemic cardiovascular disease and inclusion of a broader scope of human subjects, such as individuals with chronic kidney disease who may be more vulnerable to drug-related side effects.  

It does not contain the recommendation that sponsors of all new therapies for type 2 diabetes rule out a certain degree of risk for ischemic cardiovascular adverse outcomes, which was included in the previous draft and is typically done in these trials. 

“The FDA continues to review new clinical trial evidence and update its recommendation for drug development to reflect emerging scientific information,” said Lisa Yanoff, MD, acting director of the division for metabolism and endocrinology products in the FDA’s center for drug evaluation and research. 

“By following FDA recommendations, sponsors have shown that type 2 diabetes drugs do not have excess ischemic cardiovascular risk, which has provided reassuring cardiovascular safety information for millions of diabetes patients. Now, with this proposed approach, we will have broader, valuable safety information for these medications.” 

More than 30 million Americans have diabetes, and 90 to 95 percent of them have type 2 diabetes, the announcement stated. These individuals may suffer from serious medical complications such as nerve damage, kidney and eye damage, sleep apnea, and heart and blood vessel disease.

The new draft guidance, which replaces the FDA’s 2008 guidance, stems from the FDA’s ongoing evaluation of these cardiovascular trials which noted safety data beyond ischemic cardiovascular was desired to evaluate the safety profile of antidiabetic drugs before they were approved.

“While a healthy lifestyle may slow or even stop the disease, many patients also take medications to improve glycemic (blood sugar) control. It is important that companies robustly evaluate the medications’ safety in clinical trials to identify risks. This knowledge can help patients and their healthcare providers make the most informed treatment decisions,” the FDA concluded. 

Health systems are continuing to work to tackle the ongoing diabetes battle in the US. Most recently, The American Pharmacists Association (APhA) Foundation announced a partnership with Tabula Rasa HealthCare (TRHC) to expand the National Diabetes Prevention Program to pharmacies across the US.

The partnership will leverage pharmacies to grow the CDC’s National Diabetes Prevention program. The evidence-based lifestyle change strategies will help at-risk individuals reduce their risk of developing type 2 diabetes. 

Furthermore, technology solutions will boost pharmacies’ capacities to help with prevention efforts. Pharmacists, pharmacy technicians, dieticians, and other healthcare professionals in pharmacy practices will be trained to deliver the CDC’s lifestyle change program to at-risk patients. 

“A purposeful goal of this partnership is to address the unique needs and preferences of understood populations to prevent type 2 diabetes. We intend for Project IMPACT: Diabetes Prevention to increase access designed to produce a substantial and positive impact on patient engagement and outcomes,” said Sandra Leal, PharmD, MPH, SinFoniaRX CEO. 

The precision medication software application is designed to provide clinical pharmacists with accurate information about identify high-risk individuals to ensure proper dosage guidelines.   

“Working with our partners, we are excited about delivering an innovative model of diabetes prevention care, tailored to meet the needs of the participants and optimize healthcare system workflow, that we believe will help people lead healthier lives,” said Benjamin Bluml, RPh, senior vice president of research and innovation of the APhA Foundation. 

“We are honored and privileged to collaborate to continue expanding infrastructure within highly accessible pharmacy practice environments to deliver evidence-based diabetes prevention lifestyle change programs to the people who need it most.”