WILMINGTON, Del.--(BUSINESS WIRE)--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 SEPRA@HealthCore.com.
About Ozempic (semaglutide) injection 0.5 mg or 1 mg
Ozempic® is a prescription medicine indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Ozempic® is not recommended as a first-line therapy for patients who have inadequate glycemic control on diet and exercise because of the uncertain relevance of rodent C-cell tumor findings to humans. Ozempic® has not been studied in patients with a history of pancreatitis, so consider other antidiabetic therapies in patients with a history of pancreatitis. Ozempic® is not a substitute for insulin and is not indicated for use in patients with type 1 diabetes mellitus or for the treatment of patients with diabetic ketoacidosis.
Ozempic has a Boxed Warning for Risk of Thyroid C-Cell Tumors. In rodents, semaglutide causes dose-dependent and treatment-duration dependent thyroid C-cell tumors at clinically relevant exposures. It is unknown whether Ozempic® causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans as human relevance of semaglutide-induced rodent thyroid C-cell tumors has not been determined. Ozempic® is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Counsel patients regarding the potential risk for MTC with the use of Ozempic® and inform them of symptoms of thyroid tumors (e.g. a mass in the neck, dysphagia, dyspnea, persistent hoarseness). Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with Ozempic®.
Ozempic® is contraindicated in patients with a personal or family history of MTC or in patients with MEN 2, and in patients with known hypersensitivity to semaglutide or to any of the product components.
Patients should be referred to an endocrinologist for further evaluation if serum calcitonin is measured and found to be elevated or thyroid nodules are noted on physical examination or neck imaging. Acute and chronic pancreatitis have been reported in clinical studies.
Observe patients carefully for signs and symptoms of pancreatitis (persistent severe abdominal pain, sometimes radiating to the back with or without vomiting). If pancreatitis is suspected, discontinue Ozempic® promptly, and if pancreatitis is confirmed, do not restart.
In a 2-year trial involving patients with type 2 diabetes and high cardiovascular risk, more events of diabetic retinopathy complications occurred in patients treated with Ozempic® (3.0%) compared to placebo (1.8%). The absolute risk increase for diabetic retinopathy complications was larger among patients with a history of diabetic retinopathy at baseline than among patients without a known history of diabetic retinopathy. Rapid improvement in glucose control has been associated with a temporary worsening of diabetic retinopathy. The effect of long-term glycemic control with semaglutide on diabetic retinopathy complications has not been studied. Patients with a history of diabetic retinopathy should be monitored for progression of diabetic retinopathy.
Never Share an Ozempic® Pen Between Patients. Ozempic® pens must never be shared between patients, even if the needle is changed. Pen-sharing poses a risk for transmission of blood-borne pathogens.
The risk of hypoglycemia is increased when Ozempic® is used in combination with insulin secretagogues (e.g., sulfonylureas) or insulin.
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.
Please see Prescribing Information, including Boxed Warning for Ozempic® at www.novo-pi.com/ozempic.pdf.
About HealthCore, Inc.
HealthCore Inc. uses real world data, including claims information, to provide clinical and other scientific expertise and research services to the pharmaceutical, biotechnology and device industries, in the conduct of industry-sponsored safety, health economic outcomes, comparative effectiveness, epidemiological and late stage research projects. HealthCore’s capabilities include retrospective database design and analysis, prospective observational research design and analysis, safety and epidemiologic research services, post authorization safety study (PASS), health services research, patient and/or provider survey development and implementation, and general research consultation.
About Anthem, Inc.
Anthem is working to transform health care with trusted and caring solutions. Our health plan companies deliver quality products and services that give their members access to the care they need. With over 73 million people served by its affiliated companies, including nearly 40 million within its family of health plans, Anthem is one of the nation’s leading health benefits companies. For more information about Anthem’s family of companies, please visit www.antheminc.com/companies.
About Novo Nordisk in the US
Novo Nordisk, a global healthcare company, has been committed to discovering and developing innovative medicines to help people living with diabetes lead longer, healthier lives for 95 years. This heritage has given us experience and capabilities that also enable us to help people defeat other serious diseases including obesity, hemophilia and growth disorders. We remain steadfast in our conviction that the formula for success is to stay focused, think long term and do business in a financially, socially and environmentally responsible way. With U.S. headquarters in New Jersey and production and research facilities in four states, Novo Nordisk employs nearly 6,000 people throughout the country. For more information, visit novonordisk.us, Facebook and Twitter.