The newest diabetes drug to win FDA approval, semaglutide (Ozempic), a once-weekly injection, reduced A1C levels and weight in clinical trials, making it a kind of two-fer for many with type 2 diabetes.
"For adults with type 2 diabetes, Ozempic offers the benefit of improved glycemic control with a once-weekly dosing schedule," says Chris Clark, a spokesperson for Novo Nordisk, which markets the new drug. The drug also results in body weight reductions, Clark tells OnTrack Diabetes. Novo also markets Victoza, the same kind of drug as Ozempic, but taken daily.
The drug is expected to come on the U.S. market in the first three months of 2018.
Ozempic is a drug known as a GLP-1 receptor agonist. It is the seventh approved by the FDA for the U.S. market and the third approved for once-weekly dosing. It works by stimulating the body's own insulin production and reducing appetite.
Two doses were approved, 0.5 milligram and 1mg, and are delivered from pre-filled pens. In clinical trials, looking at more than 8,000 people with type 2 diabetes, it reduced A1C, the two- to three-month look back at blood glucose levels, by 1.5 to 1.8%, considered substantial.
The drug is meant to be used in combination with diet and exercise to improve blood sugar. The participants in the trials were also taking other drugs, such as metformin.
When Ozempic was compared with another diabetes drug, Januvia (sitagliptin), those getting the 1 mg dose of Ozempic lost about 13 pounds in the 56-week study, compared to under 4 for those on Januvia.
Side effects of Ozempic included nausea, vomiting, diarrhea, abdominal pain and constipation. The drug may be linked with possible thyroid tumors, so those with a history of a type of thyroid cancer called medullary thyroid carcinoma are advised not to use the drug.
The clinical trials also showed that Ozempic reduced the risk of heart attack, strokes, and death from cardiovascular disease, an important benefit as having type 2 diabetes increases the risk for cardiovascular disease.
As patients hear about the new option, they will be asking about it, says Amy Hess-Fischl, MD, RD, LDN, BC-ADM, CDE, a certified diabetes educator and transitional program coordinator at Kovler Diabetes Center, Chicago, and an editorial board member of OnTrackDiabetes. The research does suggest it may be more useful than similar drugs, she says. While the studies on Ozempc showed a reduction in A1C of about 1.5 to 1.8%, she says, other drugs reduce the A1C by less than 1%.
She calls the weight loss "quite impressive,'' but added that the big benefit is a reduction of cardiovascular risk.
The wholesale cost is $676 for a four to six-week supply, Clark says adding that the price is similar to other drugs in the class. Novo plans to offer a savings card program to reduce co-pays for patents on eligible commercial plans, he says. The company has been working with insurers and is hopeful that the product will be well covered, he says.