FDA OKs New Drug for Type 2 Diabetes

April 2, 2007 -- The FDA has approved Janumet, a new drug for people with type 2 diabetes.

Janumet is approved for use in addition to diet and exercise for patients with type 2 diabetes whose blood sugar is not adequately controlled by the diabetes drugs metformin or Januvia.

Janumet is taken orally twice daily with meals. It's the first and only tablet that combines Januvia and metformin, notes Merck, the drug company that makes Janumet and Januvia.

According to a Merck news release, the FDA approved Janumet based on clinical data including Januvia and metformin as separate tablets. Another study shows that Janumet is equivalent to Januvia and metformin taken together, notes Merck.

Merck says it compared Janumet to metformin in a six-month study of 701 people whose blood sugar was mildly to moderately elevated, despite taking metformin.

The patients were assigned to take Janumet or to only take metformin during the study.

More than twice as many patients taking Janumet got their hemoglobin A1c level (which indicates blood sugar control over the previous six to 12 weeks) into the recommended range, compared with those only taking metformin.

Patients taking Janumet also lost 1.5 pounds during the study, which is roughly the same amount of weight lost by patients taking metformin alone (1.3 pounds).

The risk of low blood sugar (hypoglycemia), swelling, and gastrointestinal side effects was similar in the Janumet and metformin-only groups, according to Merck.

Janumet shouldn't be taken by patients with conditions including liver disease, renal (kidney) disease, renal dysfunction, type 1 diabetes, or a complication of diabetes called diabetic ketoacidosis. 

Merck says Janumet will be "broadly available in pharmacies in the near future." Merck is a WebMD sponsor.