The real-world trial is designed to compare the long-term effectiveness of the drug, also known as Ozempic, against 40 other medications among 2,250 adults with Type 2 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,” study clinical advisor Dr. John Buse said in prepared remarks. “This trial will be relying on how doctors work with their patients in the real world with little outside guidance.”
Researchers plan to follow the trial participants for two years, measuring which participants meet their HbA1c goals. The trial will also evaluate how often participants land in the hospital due to diabetes-related conditions. Researchers also plan to examine factors like participants’ body weight change, quality of life, rates of hypoglycemia and medication adherence.
“We are proud to be a leader in the field of pragmatic study research,” lead researcher Vince Willey said. “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,” Todd Hobbs, Novo Nordisk’s CMO, added. “We invest in studies like Sepra because payers and physicians want to know how to achieve high quality care that’s cost effective.”