HealthCore, Inc., the outcomes research subsidiary of Anthem, Inc. (NYSE: ANTM) and Novo Nordisk Inc., 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.
To access information on the trial, care providers and consumers can email [email protected]
There have been postmarketing reports of acute kidney injury and worsening of chronic renal failure, which may sometimes require hemodialysis, in patients treated with GLP-1 receptor agonists. Some of these events have been reported in patients without known underlying renal disease. A majority of the reported events occurred in patients who had experienced nausea, vomiting, diarrhea, or dehydration. Monitor renal function when initiating or escalating doses of Ozempic® in patients reporting severe adverse gastrointestinal reactions.
Serious hypersensitivity reactions (e.g., anaphylaxis, angioedema) have been reported with GLP-1 receptor agonists. If hypersensitivity reactions occur, discontinue use of Ozempic®; treat promptly per standard of care, and monitor until signs and symptoms resolve. Use caution in a patient with a history of angioedema or anaphylaxis with another GLP-1 receptor agonist.
There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with Ozempic®.
The most common adverse reactions, reported in ≥5% of patients treated with Ozempic® are nausea, vomiting, diarrhea, abdominal pain, and constipation.
The risk of hypoglycemia may be lowered by a reduction in the dose of the secretagogue or insulin. Ozempic® causes a delay of gastric emptying and has the potential to impact the absorption of concomitantly administered oral medications, so caution should be exercised.
There are limited data with semaglutide use in pregnant women to inform a drug-associated risk for adverse developmental outcomes. Discontinue Ozempic® in women at least 2 months before a planned pregnancy due to the long washout period for semaglutide.