FDA OKs New Drug for Type 2 Diabetes
Janumet Combines the Diabetes Drugs Januvia and Metformin
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,
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
The patients were assigned to take Janumet or to only take metformin during
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
The risk of low blood sugar (hypoglycemia), swelling, and gastrointestinal
side effects was similar in the Janumet and metformin-only groups, according to
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.