FDA Approves Toujeo® for Type 2 Diabetes (粮食与药物管理局批准Toujeo® 治疗第二类型糖尿病)
In February 2015, The U.S. Food and Drug Administration (FDA) approved Sanofi’s new once daily long acting insulin, Toujeo (insulin glargine [rDNA origin] injection, 300 U/mL) for treatment of adults living with type 1 and type 2 diabetes. Sanofi is the same manufacturer who brought the blockbuster, Lantus, to the market. Toujeo has since launched in April 2015.
The French drug maker believes the new product, Toujeo, is better than its aging diabetes blockbuster Lantus for stabilizing blood-sugar levels but it can’t say so as a result of a recent U.S. regulatory ruling.
The approval of Toujeo was based on FDA review of results from the EDITION clinical trial program, which was comprised of a series of international Phase III studies evaluating the efficacy and safety of Toujeo in more than 3,500 adults from broad and diverse diabetes populations (type 1 and type 2). It is found to be just as safe and effective as Lantus and it produced similar blood glucose control as compare to Lantus, but with lower rates of hypoglycemia (low blood glucose).
Toujeo is a long-acting human insulin analogy indicated to improve glycaemic control in adults with diabetes mellitus. It should be taken once a day at the same time each day to lower blood glucose.
Do not use Toujeo to treat diabetic ketoacidosis.
Both Toujeo and Lantus are insulins, a hormone that prevents sugar from pooling in the blood and becoming toxic.
The most common side effect of any insulin, including Toujeo, is low blood sugar (hypoglycemia), which may be serious and can be life-threatening. Symptoms of serious low blood sugar may include shaking, sweating, fast heartbeat and blurred vision. Severe hypoglycemia may cause harm to your heart or brain. Other possible side effects may include swelling, weight gain and allergic reactions. In rare cases, some allergic reactions may be life-threatening. Injection site reactions are also possible, and may include changes in fat tissue at the injection site, skin thickening, redness, swelling and itching.
I am using Levemir manufactures by Novo of Denmark, one of its biggest competitors in the insulin market. Your Doctor will prescribe the appropriate product for you.
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Disclaimer: I am not a Medical Doctor. All my blog postings are based on my personal experience that I've went thru and what I've read up from the internet. If you've any symptoms of diabetes OR want to better manage your health, I strongly urge you to have regular medical-ups to avoid future complications. In addition, control your diet portions and have regular exercise.