Merck and Pfizer have announced that the U.S. FDA (Food and Drug Administration) has approved their new medications, Steglatro and Steglujan, for the treatment of type 2 diabetes. The active ingredient in Steglatro is ertugliflozin, and Steglujan is a fixed-dose combination medication of ertugliflozin and sitagliptin (Januvia). Both treatments are indicated for adults with type 2 diabetes, in addition to diet and exercise to improve glycemic control. Additionally, the combination therapy, Steglujan, is indicated for adults in which treatment with both ertugliflozin and sitagliptin is appropriate.
How they work
Ertugliflozin is an SGLT2 (sodium-glucose cotransporter 2) inhibitor, which affects the kidneys and allows for excess glucose to leave the body in the urine. This prevents excess glucose from being reabsorbed back into the body, thus, decreasing an individual’s blood glucose level. Sitagliptin (the other active ingredient in the combination therapy, Steglujan) is a DPP-4 (dipeptidyl peptidase 4) inhibitor. DPP-4 inhibitors increase the level of incretin in the body, which inhibits the release of glucagon. This decrease in glucagon helps decrease blood glucose levels. Both Steglatro and Steglujan are expected to be on the market by early 2018. An additional medication, Segluromet (ertugliflozin and metformin) will also be available soon.
The FDA approval was based on seven Phase 3 clinical trials that involved nearly 5,000 individuals with type 2 diabetes. During these trials, the effect of Steglatro on its own, as well as in combination with metformin, sitagliptin, insulin, and sulfonylurea was studied. Steglatro in combination with both metformin and sitagliptin was also investigated. Overall, Steglatro on its own, as well as with sitagliptin, contributed to significant reductions in A1C levels. In addition, in several of the studies, specifically the VERTIS SITA2 26-week study, Steglatro, in combination with metformin and sitagliptin, also significantly reduced body weight, fasting plasma glucose, and systolic blood pressure, when compared with placebo. Despite these findings, Steglatro is not indicated for management of hypertension or weight loss specifically.
The most common adverse reactions or side-effects associated with ertugliflozin (Steglatro) were female genital mycotic infections (fungal infections). Steglatro is not indicated for use in individuals with diabetic ketoacidosis or T1D. The main warnings of Steglatro include increased risk of low blood pressure (hypotension), ketoacidosis (high levels of acid in the blood), impaired kidney functioning, and low blood sugar. The most common side effects of ertugliflozin with sitagliptin (Steglujan) were common colds, headache, female genital mycotic infections, and upper respiratory tract infections. Steglujan is not indicated for use by those with type 1 diabetes, diabetic ketoacidosis, and potentially, those with a history of pancreatitis. Individuals taking Steglujan should also be monitored for signs of serious allergic reactions, low blood pressure, impaired kidney function, low blood sugar, heart problems, pancreatitis, severe joint pain, and ketoacidosis.1-3
FDA Approves SGLT2 Inhibitor Steglatro (ertugliflozin) and Fixed-Dose Combination Steglujan (ertugliflozin and sitagliptin) for Adults with Type 2 Diabetes. Merck Pharmaceuticals. http://www.mrknewsroom.com/news-release/corporate-news/fda-approves-sglt2-inhibitor-steglatro-ertugliflozin-and-fixed-dose-comb. Published December 22, 2017. Accessed January 2, 2018.
Steglatro Prescribing Information. FDA.gov. https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209803s000lbl.pdf. Published December 2017. Accessed January 2, 2018.
Steglujan Prescribing Information. FDA.gov. https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209805s000lbl.pdf. Published December 2017. Accessed January 2, 2018.