This week, the U.S. Food and Drug Administration (FDA) approved Janumet, a pill that combines the two previously approved Type 2 diabetes drugs sitagliptin (brand name Januvia) and metformin (Glucophage and other names). Janumet is manufactured by Merck & Co., Inc., and is expected to be available in pharmacies nationwide soon.
Treatment with Janumet is meant to help control blood glucose levels in people with Type 2 diabetes who either have not achieved good control with metformin or sitagliptin alone or who already take both metformin and sitagliptin. Janumet should be taken twice a day with meals and will cost $4.86 per day.
A recent study of Janumet’s effectiveness involved 701 people who had mildly to moderately elevated HbA1c levels (a measure of blood glucose control over time) despite taking metformin. The participants were randomly assigned to receive sitagliptin or a placebo (inactive pill) in addition to their metformin. Neither the participants nor the researchers knew who received the drug and who received the placebo.
After 24 weeks, the participants who received metformin plus sitagliptin (the combination found in Janumet) had HbA1c levels 0.7% lower than those who had received metformin plus placebo. In fact, 47% of people who took metformin plus sitagliptin achieved the American Diabetes Association–recommended HbA1c goal of less than 7% compared to only 18% of those who took metformin plus placebo. People who took metformin plus sitagliptin also experienced lower postmeal blood glucose levels than those who took metformin plus placebo. Both groups experienced similar amounts of weight loss (about 1.5 pounds), and similar low rates of hypoglycemia (low blood glucose), edema, and gastrointestinal reactions (such as diarrhea, nausea, vomiting, or stomach pain).
The components of Janumet work together to control blood glucose levels through multiple mechanisms. Sitagliptin blocks a certain enzyme, which in turn helps increase the pancreas’s production and secretion of insulin and block the liver’s production of glucose. (For more information about how sitagliptin works, please see the blog entry “New Diabetes Drug Januvia Approved by FDA”.) Metformin makes the body’s cells more sensitive to insulin and also lowers the liver’s production of glucose.
Janumet should not be taken by people who have kidney or liver disease, and people who begin Janumet therapy should have their kidney function checked before starting and annually as long as they are taking the drug. Like metformin alone, Janumet carries the very small but serious risk of lactic acidosis, a condition in which lactic acid builds up in the blood, depriving the body’s tissues of oxygen. This condition, which can be fatal, is more likely to occur in people who have kidney disease, liver disease, congestive heart failure, or who drink a high number of alcoholic beverages. These people should not take metformin-containing drugs such as Janumet.
Thanks for an interesting article. I hope it helps a lot of people.
It sound promising to help those of us who are type 2 diabetics.
David
Posted by Dbuitt | Apr 11, 2007 at 1:27 pmI take metformin in place of Avandia or Lipitor. When 1st taken, I noticed the amount of diarhea, stomach pains was getting. Was paying over $200 for Avandia; doc got me with Metformin $12 for 30 pills at Walmart. It’s a Godsend when I’m broke; jobless; must needed pills for my Diabetes Type 2. I hope they don’t remove this pill from the market. I might have to search for another pill to take at $12 a month. Trying to get my glucose down since it keeps going higher. Thanks for the info, keep it coming.
Posted by hopelessmary | Apr 15, 2007 at 1:41 pmWell i have been on Janumet now for about 4 and a half months and between takeing the medication and watching what i have been eating / cutting out all pop and junk foods i have lost 24 pounds sence july of this year!!!! (in 4 1/2 months!) … SO i am glad and happy that have came out with this medication!
Posted by darkfeary474 | Oct 26, 2007 at 11:07 ami would like to know where this drug is being manufacuted, as recently finding out i am diabetic and given janumet when getting to the bottom of bottle found a few of the pills broken and although coated some were half the size. since i am taking this drug who ar what is taking care of quailty cintrol?
Posted by margaret h | Jun 23, 2008 at 7:05 amMargaret H,
Janumet is manufactured by Merck & Co. You can find their contact information at .
Posted by Tara Dairman, Web Editor | Jun 23, 2008 at 9:54 amHELLO CUSTOMER SERVICES, I WANT TO KNOW WHAT IS THE SIDE EFFECTS OF THIS MEDS PLEASE.
Posted by shirley robinson | Oct 01, 2009 at 6:09 amHi Ms. Robinson,
Thanks for your question. Some of the most common side effects of Janumet are diarrhea, abdominal pain, nausea, vomiting, nose or throat infection, and headache. Rare but serious side effects of this drug include lactic acidosis (a condition caused by the buildup of lactic acid in the blood) and allergic reaction.
Although this medicine generally does not cause low blood glucose (hypoglycemia) when taken by itself, hypoglycemia may develop in people taking Janumet along with certain other oral diabetes drugs such as sulfonylureas (brand names Diabinese, Diabeta, Glynase, Micronase, Glucotrol, Glucotrol XL, Amaryl) and meglitinides (Prandin, Starlix).
Thank you for your interest in Diabetes Self-Management.
Sincerely,
Posted by Diane Fennell | Oct 01, 2009 at 9:47 amDiane Fennell
Web Editor