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Diabetes Drug Assessed Long-Term Against All Other Treatments

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(StillWorksImagery, Pixabay)

17 Oct. 2018. A new clinical trial is testing the drug semaglutide for people with type 2 diabetes against as many as 40 other diabetes treatments when used as a supplemental drug over 2 years. The post-marketing study — undertaken after clearance by FDA — is conducted by HealthCore, the outcomes research unit of health insurance provider Anthem, testing semaglutide, marketed under the brand name Ozempic by drug maker Novo Nordisk.

The drug Ozempic is prescribed for people with type 2 diabetes who need extra help controlling their blood glucose levels. Diabetes is a chronic disorder where the pancreas does not create enough insulin to process the sugar glucose to flow into the blood stream and cells for energy in the body. In type 2 diabetes, which accounts for at least 90 percent of all diabetes cases, the pancreas produces some but not enough insulin, or the body cannot process insulin. Centers for Disease Control and Prevention says diabetes affects 30.3 million people in the U.S., with the number of people with the disease tripling in the past 20 years as the population ages and more people become overweight.

Ozempic is part of a class of drugs known as glucagon-like peptide 1, or GLP-1 receptor agonists that activate GLP-1 peptides to promote production of insulin in the pancreas. The drug is given as a self-administered injection under the skin with a pen-like device, and prescribed as a supplemental treatment for people who need extra help controlling their blood glucose levels beyond diet, exercise, and first-line treatments. While Ozempic is cleared for marketing in the U.S. by FDA, the drug comes with a long list of conditions and adverse effect warnings.

The clinical trial — with the acronym SEPRA, short for a 26-word official title — is recruiting 2,250 adults, age 18 to 65, with type 2 diabetes who are also members of an affiliated Anthem health insurance plan. The study aims to compare the effects of Ozempic in real-world settings over a period of 2 years. Participants will be randomly assigned to receive Ozempic to help control blood sugar levels or other approved prescribed drugs or treatments on the market, as well as the first-line drug metformin. Researchers expect as many as 40 other drugs or treatments to be used by participants in the trial.

During this time, the study team will record participants blood glucose levels, defined as hemoglobin A1c, or HbA1c, under the target of 7 percent, the trial’s main effectiveness measure. The HealthCore researchers are also tracking changes in HbA1c levels, body weight changes, hypoglycemia rates, and overall vital signs, as well as hospitalizations, emergency room visits, and quality of life indicators.

John Buse, an endocrinologist at University of North Carolina medical school, director of the school’s diabetes center, and an adviser to the project says in a HealthCore statement that “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.” Buse adds, “This trial will be relying on how doctors work with their patients in the real world with little outside guidance.”

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