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FDA Approves Semaglutide for Type 2 Diabetes

Novo Nordisk news release; 2017 Dec 5

The FDA has approved Ozempic (semaglutide) as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.

Indications: Ozempic is a glucagon-like peptide 1 receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Dosage and administration: Start at 0.25 mg once weekly. After 4 weeks, increase the dose to 0.5 mg once weekly. If after at least 4 weeks additional glycemic control is needed, increase to 1 mg once weekly. Administer once weekly at any time of day, with or without meals.

Efficacy and safety: Approval is based on results from a Phase 3a clinical trial program, where Ozempic produced clinically meaningful and statistically significant reductions in A1c compared with placebo, sitagliptin, and exenatide extended-release. It also resulted in reduced body weight.

Side effects/risks: The most common adverse reactions are nausea, vomiting, diarrhea, abdominal pain, and constipation.

Citation:

Novo Nordisk receives FDA approval of Ozempic (semaglutide) injection for the treatment of adults with type 2 diabetes. [news release]. Plainsboro, NJ: Novo Nordisk A/S. December 5, 2017. https://www.prnewswire.com/news-releases/novo-nordisk-receives-fda-appro.... Accessed December 6, 2017.

Ozempic [package insert]. Plainsboro, NJ: Novo Nordisk A/S. 2017. http://www.novo-pi.com/ozempic.pdf. Accessed December 6, 2017.

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Cochrane on Delaying Diabetes in People with IGT, Cochrane; 2017 Dec 5; Hemmingsen, et al

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Hospitalization in Those With, Without Diabetes, Diabetes Care; ePub 2017 Nov 17; Burrows, et al