New Drug Approved

On January 25, the US Food and Drug Administration (FDA) approved the injectable diabetes medicine liraglutide (brand name Victoza), developed by Novo Nordisk. Victoza is the first once-daily treatment in the class of drugs known as GLP-1 agonists. (Exenatide [Byetta] is the other member of this drug class.)

GLP-1 agonists work by stimulating the insulin-producing beta cells of the pancreas to release insulin in response to high blood glucose levels. Because of their glucose-dependant mechanism of action, drugs of this class are associated with a low rate of hypoglycemia (low blood glucose).

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In clinical trials, Victoza has been associated with reductions in A1C (an indicator of blood glucose control over the previous 2–3 months) and weight loss. It can be administered at any time during the day and is injected into the subcutaneous (below the skin) tissue of the abdomen, thigh, or upper arm using a prefilled pen device. Victoza is approved for use in adults with Type 2 diabetes.

This medicine has not been studied in combination with insulin and should not be used to treat Type 1 diabetes or diabetic ketoacidosis (a potentially life-threatening condition marked by a chemical imbalance in the body). It is not recommended as a first-line therapy for people who have not achieved blood glucose control using diet and exercise.

Victoza should not be used in people with a personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2. (In preclinical testing, this medicine caused thyroid tumors in rats and mice.) The most common side effects in people using Victoza are headache, nausea, diarrhea, and the development of antibodies to the medicine.

Victoza is expected to be introduced into the US market within the next 4–6 weeks. For more information, see the Victoza Web site.

  • Rudy

    Here is some interesting info about a clinical research study now enrolling people with Type 2 Diabetes who struggle to control their blood sugar levels. This study is going on at various study centers around the US. You can find more info here: http://www.DiabetesStudies.org

  • Still too fat

    My diabetes nurse educator mentioned this drug at our most recent meeting. I use Byetta with good results, but she encouraged me to look into Victoza because it seemed to be better tollerated and in particular due to the weight loss association.

    It would be interesting to hear from anyone who’s been on Victoza, even if just for a couple of weeks.

  • Alma Crabtree

    Will taking this drug eliminate the use of insulin lantus and metformin???

  • Vonnie De Rico

    I am interested in this new drug. My doctor took me off Metformin because I have Stage III kidney disease. I still take Glyburide and Levimer insulin pen. I wonder if I could benefit?

  • Gilda

    I would be very interested to know more about this product also. The question on eliminating the use of insulin lantus and metformin is a good one as well. Please keep me informed.

  • dale

    What about the long term effects of drugs that stimulate the pancreas to release more insulin. does this not eventually cause a burn out of the beta cells and they just quit entirely?

  • Bill S

    I did not tolorate Byetta well after about 15 months. (nausea and diarrhea) Can I expect the same problems? My first year on Byetta was great, weight loss and great A1c. I am looking for a replacement. Is this it????

  • Kate

    Interesting. I am also taking Metformin and insulin as well as Byetta. When I first started taking Byetta I was told it would help me lose weight but haven’t seen where it’s been helpful. I hope this new drug does. Would like to know.

  • Diabetes India

    What is the difference in new drug and Byetta which is also a GLP-1 analogue in terms of side effects, efficacy, control of blood glucose, weight loss, insulin resistance and impact on HbA1c.

    Will the cose remain in about the same range?

    Thanks

    Diabetes India
    http://diabetesindia.org

  • Tony D

    I started taking Victoza last week, 5th dose , still on the entry level dose .6 day 8 move to .12.

    2000 Mg of Met ER is not managing the sugar level, even with 30 min of cardio a day. at age 50 could stand to loose 10 to 15 lbs. may be 20 still very active. stressed from work but play in a band at night to de-stress. but still need to work on the stress and diet part, can always do better. used to live to eat now eat to live.

    six months ago so the doc offered me two choices byetta and actos. opted to go the exercise route, did not work.

    So last week was offered it again, I had heard that victoza was under consideration for approval, and prior to going to the doctor did some research as to status. Stuck between a rock and a hard-place, no interest in Actos because of water retention, Junevia was not recomended, my issue is fasting sugar levels.

    Because I travel, two shots a day linked to meals was not going to work. really never know when I am going to eat.

    Not initially offered, So I asked about Victoza, we discussed the risks thought about it for 15 mins. (Do your home work prior to going to the doctor) and left with a sample pen.

    I was offered to participate in a study 6 months ago but opted out and Victoza was one of the drugs being evaluated against Junvieva and Actos.

    So Day 5 of victoza yields the following:

    nausea not a bad as day 1 near none. No headache,
    still getting some stomach distress after meals. you really need to limit your intake, this is what contributes to the weight loss.
    Getting better at the injection, need to use a very light touch.
    I does not hurt going in key pull it out straight keep you hand steady. (Maybe if I drink less coffee)

    Morning levels down to 117 today have not seen this number in 8 years. Woke up 201 the day I started, and I had the needle for a day still fooling my self there was another way. Early evening numbers are 99 vs. 154.

    A little tired at the end of the day, probably due to the lower blood sugar but does not effect my exercise

    Does come with some hefty warnings but humans are not made the up the same as mice and look at the warnings on your diet drinks.

    Once a day is better than than twice a day and is not linked to meals. so I can take the shot, go for a run and eat breakfast after.

    The alternative of not regulating blood sugar are far worse and could lead to the same result.

    Being treated by the Joslin Center in CT. looking for other comments on the drug.

  • Paul Snyder

    I got my Victoza today, I am worried because of all the other meds I take. + I have a lot of stomach irritation on & off also. I will let you know what it does for me as time goes on. I didn’t like reading about the sick rats. Posted 12 April 2010 2325 hrs eastern time.

  • Linda Lazarides

    Since insulin levels are already high in insulin resistance, drugs whose mechanism is to push insulin even higher risk increasing the side effects of hyperinsulinemia: water retention and prevention of fat loss. This problem may be slightly mitigated if the drug works in response to glucose levels, but I feel more clinicians should be aware that although losing excess body weight is a priority for diabetics, high insulin levels and water weight can be powerful obstacles.
    Linda Lazarides

  • Mike

    Hello I have been on Victoza since October 1st and have lost 35 pounds. I’m eating right most of the time and exercising 4 times a week. I hope to lose another 35 pounds over the next 3 to 5 months. How long is this medicine safe to use?

  • Sarah

    This medication has changed really changed my life. I started it in April and have lost about 40 lbs without making major changes. Yes, the first month was miserable with pretty much every side effect in the book, but that all passed. I’m still losing weight, about a 1 kg every week or so. After seeing the weight starting to come off, I was able to feel better about myself and start eating better and trying to have healthier habits in general. When I started I had an A1c of 6.9, and in 3 months, that has dropped to a 5.2.

    Definitely a drug worth considering.

  • Mavin

    Ive been having some home grown remedies and effectively controlling sugar… but i’m gaining weight. Want to try Victoza.. but just a little afraid of it’s long term effects.

    Vini