The Federal Drug Administration of U.S has approved Janumet, produced by Merck & Co., Inc.
The trademark Janumet was assigned to MK-0431A, which is the company's investigational oral medicine combining Januvia or sitagliptin phosphate, with the older widely-used generic drug, metformin for type 2 diabetes.
Janumet is meant to provide an additional treatment option for patients who need more than one oral agent to help control their blood sugar.
Data supporting Janumet were previously disclosed earlier this year at the 66th annual meeting of the American Diabetes Association (ADA) as well as the 42nd annual meeting of the European Association for the Study of Diabetes (EASD).
Data presented at the ADA included a 24-week, double blind study of patients who had inadequate glycemic control with metformin (at least 1,500 mg daily).
In this study, sitagliptin phosphate 100 mg once daily added to patients inadequately controlled on metformin ,led to a significant reduction in sugar levels as against a placebo.
It was also observed that the concurrent administration of sitagliptin phosphate with metformin was generally well tolerated, with no increased incidence of hypoglycemia or gastrointestinal adverse events.
The most common side effects reported with sitagliptin phosphate (greater than or equal to 5 percent) were stuffy or runny nose and sore throat, upper respiratory infection and headache.
Type 2 diabetes, a condition in which the body either doesn't produce enough insulin or the cells ignore the insulin, is one of the most costly and burdensome diseases. Left untreated, it can result in heart disease, blindness, amputations as well as nerve and kidney damage.
The number of new cases of type 2 diabetes among middle aged Americans has doubled over the past three decades, fueled largely by increasing rates of obesity, the ADA says.
According to the latest World Health Organization (WHO) estimates, the number of people worldwide with diabetes climbed from 30 million in 1985 to 171 million in 2000. There was a 69 percent increase from 5.2 percent to 8.8 percent in diabetes prevalence from 1995 to 2005, exceeding the WHO's estimate of a 60 percent global rise between 1995 and 2030 and 39 percent between 2000 and 2030.