New Combination Diabetes Drug Janumet Approved

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.

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  • Dbuitt

    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

  • hopelessmary

    I 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.

  • darkfeary474

    Well 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!

  • margaret h

    i 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?

  • Tara Dairman, Web Editor

    Margaret H,

    Janumet is manufactured by Merck & Co. You can find their contact information at http://www.merck.com/contact.

  • shirley robinson

    HELLO CUSTOMER SERVICES, I WANT TO KNOW WHAT IS THE SIDE EFFECTS OF THIS MEDS PLEASE.

  • Diane Fennell

    Hi 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,
    Diane Fennell
    Web Editor

  • Carole H.

    I have been on 500mg twice a day of Janumet since the beginning of August 2009 and I have not noticed any significant changes in my glucose levels however I have experienced weight loss (without any excercise) since I have been on this medication. I have lost about 10 to 15 pounds. Is this normal for this medication to have this effect on some people?

  • Arnold M./ Dec 26 2009

    I had added Janunia 100mg to my metformin 1000mg twice a day about 2 years ago. My HbA1C started to improve immediately.When my doctor found out that Janumet 50/1000mg was available he started me on it(twice a day).Guess I am quit fortunate as my last HbA1c was 5.3. I have also lost about 60 lbs and feel like a new person.

    Bravo Merck & Co.Inc

  • KATINA

    I HAVE BEEN TAKING JANUMET FOR ABOUT2 MONTH. AND I TWO WAS CONCERNED ABOUT THE DIARRHEA. AS YOUR BODY GET USED TO THIS MEDICINE YOU WONT HAVE THE STOMACH PAINS BUT THE DIARRHEA WILL NOT STOP. IT’S BEEN KINDA HARD FOR ME BECAUSE THIS MEDICINE WILL ALLOW YOU TO STOP WITH THE JUNK FOOD AND SODA. BECAUSE LIKE ME IF YOU LIKE IT AND DRINK A LOT OF SODA YOU WILL START TO FEEL NOT GOOD. SO MY JOURNEY WITH THIS MEDICINE IN TWO MONTH I HAVE LOST 18LBS. I FEEL IT’S THE BEST FOR ME. I DONT WANT TO TAKE THIS MEDICINE FOR-EVER BUT IM GONNA WORK HARDER ON MY DIET AND EXERCISE. IT WILL BE ALL WORTH IT IN THE END.

    THANK YOU

  • craig

    I been taking janumet and it has i ok for the short time i been taking it my like my number so far.

  • jack

    Janumet is combination of Sitagliptin Phosphate-Metformin Hydrochloride. Even generic equivalent of Janumet is available online. I use the generic one, got it online at International Drug Mart.

  • Marcia

    After being maxed out on Metphormin and still getting an A1C reading of 7.3, my doctor put me on Janumet beginning yesterday. This morning my blood sugar reading was already down about 40 points from yesterday!! My reading this morning was 127…….WOO HOO!!!

  • mike

    I was taking Januvia and Metformin for two months and then my doc swithced me to Janumet 50/500 last week. The only side effects I have is the stuffy nose/cough stuff but I thought I may have been getting a cold before he switched so don’t know which is which. How long would the side effects last if this is just from the Janumet?

  • nwe nwe win

    My doctor advice me to to take janumet 50/850 mg after a heavy meal like for e.g. after a dinner party even though I am still on metformin and thiazolidinediones. I do monitor my blood sugar level everyday 3 times a day as I am a type two who has been recently diagnose. Should I take Janumet even though I am doing well with the other two drugs

  • Giacomo

    I have been on Janumet 50-1000 for two weeks. I take two tablets a day.

    My numbers keep going up rather than down. I was on Prandin and Metformin and was doing much better in controlling my blood sugar.

    Is this uncommon?

  • maridiaz

    i have been taking janumet 850 for about 3 months 2 times a day , my blood sugar levels are controlled but i am experiencing pain on the bottom of foot but i want to now why and also want to now what i can do about it.

  • V.K.Gupta

    Dated; September 5,2012
    New Delhi
    I have been advised to Take ” Janumet” 1 tablet a day post lunch. I am also taking ” Gemer P2 ” and “Volibo 0.3″ 1 tablet each thrice a day. I request to advise me whether the above prescription is adequate and suitable to control Type-2 BLOOD SUGAR ranging 200-250. I am 62 year old and not diagnosed for any KIDNEY Problem so far. My BP is under control 80/120.
    Thanks

  • V.K.Gupta

    Dated; September 5,2012
    New Delhi
    I have been advised to Take ” Janumet 500mg” 1 tablet a day post lunch. I am also taking ” Gemer P2 ” and “Volibo 0.3″ 1 tablet each thrice a day. I request to advise me whether the above prescription is adequate and suitable to control Type-2 BLOOD SUGAR ranging 200-250. I am 62 year old and not diagnosed for any KIDNEY Problem so far. My BP is under control 80/120.
    Thanks

  • Maria Celeste Ribeiro

    Comecei a tomar Janumet 50/850a mais o menos uma semana, ontem tive desmaio com vomito é perigoso, estou preocupada. Fui diagnosticada com hemoglobina glicada a 6,7%. Diabete Mellitus.Mas todo essse resultado foi a primeira vez, devo fazer novos exames para confirmação da doença.

  • ajay kumar

    I was diagnosed diabetic about three months ago n that time HbA1c was 10.I was put on JANUMET 50/500 twice a day.After three months my HbA1c is 5.8.Should the dose of the medicine be reduced/regulated now ?

  • SRAWAN KUMAR DHOAN

    Required informtion regarding janument 50/1000 & 50/500 which one is more powerer tablet
    if a man take a pill of janument 50/1000 in a day who many pill they have to required of 50/500 power janumet