A new diabetes pill to be called Janumet that combines the recently approved drug Januvia with the old standby metformin significantly reduces both post-meal and fasting glucose levels in type 2 diabetics, according to data presented Dec. 5th by Merck & Co. Inc.
In a 24-week clinical trial, Merck gave 1,091 patients who had never been treated for diabetes a combination of Januvia and metformin or a placebo.
Merck hopes to get Food and Drug Administration approval of Janumet, a treatment which combines Januvia and metformin. Januvia was approved by the FDA in October.
Patients who before treatment with Janumet had an average blood glucose level of 287 milligrams per milliliter two hours after eating saw this reduced to 170 after taking the combination drug. The American Diabetes Association recommends a level of 180 or less two hours after eating.
Patients who before treatment with the combination drug had an average blood glucose level of 197 milligrams per milliliter on an empty stomach saw this reduced to 127 after taking Janumet. The American Diabetes Association recommend a level of 130 or less on an empty stomach.
"Typically, oral medications for type 2 diabetes principally either reduce post-meal glucose levels or reduce fasting blood glucose levels. These study data are important because they showed substantial reductions in both measures of blood glucose levels," said Dr. John Amatruda, vice president of clinical research for Merck.
Merck said the treatment was generally well tolerated, with the most common side effects of the combination treatment including diarrhea, nausea, abdominal pain, and vomiting.
Merck has already asked the FDA -- which approved Januvia just over a month ago -- to approve Janumet, and expects a decision from the agency by March.