The US Food and Drug Administration has approved three related medications to be used in combination with diet and exercise to improve blood sugar control in patients with type 2 diabetes. All three medications contain the ingredient alogliptin.
While alogliptin is a new ingredient, metformin hydrochloride and pioglitazone have previously been approved for the treatment of type 2 diabetes.
"Ask your doctor about diabetes Rx options."
Insulin is a hormone that helps the body turn sugar in the blood into energy for the body. In people with type 2 diabetes, the body either does not make enough insulin or does not use insulin properly, which leads to rising levels of blood sugar. Eventually, high blood sugar can increase the risk of serious health problems, including heart disease, kidney damage, nerve damage and blindness.
"Controlling blood sugar levels is very important in the overall treatment and care of diabetes," said Mary Parks, MD, director of the Division of Metabolism and Endocrinology Products in the FDA’s Center for Drug Evaluation and Research. "Alogliptin helps stimulate the release of insulin after a meal, which leads to better blood sugar control."
Nesina, Kazano and Oseni went through rigorous testing before being approved. All three medications were studied as stand-alone therapies and as combination therapies with other diabetes medications, including insulin and sulfonylureas.
Researchers studied the safety and effectiveness of Nesina in about 8,500 patients with type 2 diabetes across 14 clinical trials. Results showed that Nesina reduced levels of HbA1c, a measure of blood sugar over time, by 0.4 percent to 0.6 percent compared to placebo (fake pill) after 26 weeks of treatment. While an HbA1c of 5.7 percent or less is considered normal, an HbA1c of 6.5 percent or more is considered to be diabetes.
The most common side effects of Nesina were stuffy or runny nose, headache and upper respiratory tract infection.
Even though Nesina has been approved, the FDA wants more studies on particular aspects of Nesina: a cardiovascular outcomes trial; a study that monitors patients for liver problems, serious cases of pancreatitis (inflammation of the pancreas), and severe hypersensitivity reactions (undesirable reactions caused by a normal immune system); and three different studies on the use of Nesina in children.
The safety and effectiveness of Kazano was shown in four studies that included more than 2,500 patients with type 2 diabetes. Patients taking Kazano had 1.1 percent reduction in HbA1c compared to patients taking Nesina, and a 0.5 percent reduction compared to those taking metformin after 26 weeks of treatment.
Common side effects of Kazano included upper respiratory tract infection, stuffy or runny nose, sore throat, diarrhea, headache, high blood pressure, back pain and urinary tract infection.
As with Nesina, the FDA wants more studies on Kazano. These studies should also include one in which patients are monitored for liver problems, pancreatitis and severe hypersensitivity reactions. Another study should test the safety and effectiveness of Kazano in children.
Oseni was shown to be safe and effective in four studies that included more than 1,500 patients with type 2 diabetes. Treatment with Oseni reduced HbA1c by 0.4 percent to 0.6 percent compared to treatment with pioglitazone alone and by 0.4 percent to 0.9 percent compared to treatment with alogliptin alone.
The most common side effects of Oseni were stuffy or runny nose, sore throat, back pain and upper respiratory tract infection. Oseni also carries a Boxed Warning for heart failure linked to the use of pioglitazone.
The FDA is requiring similar studies on Oseni as those required for Nesina and Kazano.
Nesina, Kazano and Oseni are distributed by Takeda Pharmaceuticals American, Inc.