FDA Approves Higher Dose of Ozempic
Ozempic is now available in three doses to improve blood sugar in people with type 2 diabetes.
The FDA has approved a 2 mg dose of Ozempic (semaglutide) injection, a once-weekly glucagon-like peptide-1 (GLP-1) analog to improve blood sugar in adults with type 2 diabetes. Developed by Novo Nordisk, Ozempic is now available in three doses (0.5 mg, 1 mg, and 2 mg) to help people with type 2 diabetes reach their blood sugar (A1C) goal.
The approval is based on the phase 3 SUSTAIN FORTE, which found the higher dose of Ozempic helped patients who needed additional glycemic. In the trial, people with an average starting A1C of 8.9% treated with Ozempic 2 mg achieved a reduction in blood sugar of 2.1% at week 40 compared with 1.9% with Ozempic 1 mg.
In the previous phase 3 SUSTAIN trial where up to 73% of people with type 2 diabetes treated with the 1 mg dose lowered their blood sugar and reached the American Diabetes Association target of <7%.
Juan Pablo Frias, M.D.
With the higher dose, the most common adverse events were gastrointestinal. Gastrointestinal adverse reactions occurred more frequently among patients receiving Ozempic 2 mg (34.0%) vs Ozempic 1 mg (30.8%).
“Type 2 diabetes is a complex disease that can progress over time even if a person is managing it with medication, diet and exercise,” Juan Pablo Frias, M.D., medical director of Velocity Clinical Research in Los Angeles and principal investigator of SUSTAIN FORTE study, said in a press release. “With a 2 mg dose, we have an additional option so patients can stay on the same medication therapy even if their blood sugar needs shift.”
In this episode of the "Meet the Board" podcast series, Briana Contreras, Managed Healthcare Executive editor, speaks with Ateev Mehrotra, a member of the MHE editorial advisory board and a professor of healthcare policy and medicine at Harvard Medical School. Mehtrotra is also a hospitalist at the Beth Israel Deaconess Medical Center in Boston. In the discussion, Contreras gets to know Mehrotra more on a personal level and picks his brain on some of his research interests including telehealth, alternative payment models and price transparency.
Listen
Diabetes Management & Telehealth with Leslie Kolb
June 11th 2020Association of Diabetes Care and Education Specialists, chief science and practice officer, Leslie Kolb chats with MHE Associate Editor Briana Contreras in MHE's newest podcast Tuning into the C-Suite about diabetes management and how it's affected by the use of telehealth, especially during the current and trying times of the COVID-19 pandemic.
Listen
