Novo Nordisk and HealthCore, which manufacturers the once weekly GLP-1 receptor agonist Ozempic (semaglutide), are working together to launch the first of its kind pragmatic study to understand the benefits of semaglutide as compared with all other available diabetes drugs in a real-world pragmatic clinical trial for Type 2 diabetes—one of the nation’s fastest growing chronic diseases.
The randomized Ozempic pragmatic trial, “Long-term comparative effectiveness of once weekly SEmaglutide versus standard of care in a real world adult US population with type 2 diabetes – a randomized PRAgmatic clinical trial,” or SEPRA, will compare the long-term effectiveness of Ozempic to potentially 40 other medications among 2,250 adult consumers with Type 2 diabetes. The trial aims to learn whether Ozempic leads to better outcomes or impacts the need for health services compared to other FDA-approved drugs to treat diabetes.
“Because the SEPRA trial seeks to find out what happens with people using anti-diabetic therapies after FDA approval, it may be of greater interest to more people and doctors than a standard randomized clinical trial, which requires intense monitoring and coaching of consumers to take medications,” said study clinical advisor Dr. John Buse, director, Diabetes Center at the University of North Carolina School of Medicine. “This trial will be relying on how doctors work with their patients in the real world with little outside guidance.”
HealthCore researchers will follow consumers participating in the trial for two years from when they enroll to determine whether they met their HbA1C goals in comparison to those treated with drugs other than Ozempic, as well as determine whether consumers using these drugs consume fewer health services, such as ER visits and hospitalizations. The study will also compare body weight change, patient-reported outcomes such as quality of life, hypoglycemia rates, and adherence and persistence with treatment and safety.
“We are proud to be a leader in the field of pragmatic study research,” said SEPRA lead researcher Vince Willey, HealthCore principal scientist. “We believe this type of collaboration and acceleration of research demonstrated in SEPRA will help in identifying the therapies with the best outcomes for a large and diverse population.”
“We strongly believe in the clinical value of this medication, and are excited to learn more about its real-world use in adults with type 2 diabetes,” said Todd Hobbs, chief medical officer, Novo Nordisk Inc. “We invest in studies like SEPRA because payers and physicians want to know how to achieve high quality care that’s cost effective.”
GLP-1 receptor agonists are one of the newest drug classes for treating Type 2 diabetes with an estimated 1.3 million Americans currently filling prescriptions for them. While studies used for FDA approval have demonstrated the efficacy of the drugs in a clinical trial setting, there is limited evidence about their actual benefit in a real-world environment.
(Source: HealthCore, Inc.)
Filed Under: Drug Discovery and Development