Novo Nordisk is well-known in the diabetes community for its insulins, Novolog and Levemir, used to treat mainly type 1 diabetes. But in the last year, Novo launched a new kind of injectable, a “first line of defense for people with type 2 diabetes” called Victoza (generic: liraglutide). It’s a glucagon-like peptide-1 (GLP-1) drug designed to stimulate insulin secretion when hyperglycemia (high blood sugar) is present.
Victoza is still the new kid on the block here in the US, having just been approved by the FDA on January 25. It was approved in Europe last July, and has already been used by a fair number of patients there.
The big question on the market, and among doctors and patients now is, how will Victoza stack up against Byetta, the most well-known injectable drug for type 2 diabetes? Byetta has been very successful as a weight-loss aid, but the nausea it causes makes it intolerable for some people.
One big difference is that Victoza has a longer half-life, so it can be injected just once a day, at any time. Byetta, by contrast, hast to be taken at every meal.
How Well It Works
Through an online query, I was lucky to hear from Raymond, living with type 2 diabetes in England: “The doctor prescribed Victoza for me on the 6th of February and I have been taking 0.6mg per day at 8am. I have been able to reduce my insulin from 160 units per day to 100.”
The side effects, he says, were some nausea and stomach pains which lasted only about a week. “My appetite and hunger has been reduced and I seldom finish my evening meal. Most mornings I have to force myself to eat breakfast but I know I must keep a regular eating pattern. The Victoza I believe has really helped me as I was fast becoming insulin-intolerant.”
So what happens when patients combine Victoza with their usual oral anti-diabetes drugs? Funny you should ask. Diabetes Care recently published online the results of the LEAD™ 6 extension study, showing what happens when patients switched from Byetta to Victoza, in addition to the oral drugs. The data showed:
• Mean A1C decreased from 7.2% to 6.9%
• A greater percentage of patients reached their A1C targets (42.5% vs. 57.9%)
• Patients also experienced further reductions in fasting plasma glucose, body weight, and systolic blood pressure
Potential Risks
OK, so Victoza received two thumbs up from both Raymond and Diabetes Care — but there are still some concerns. Victoza was given a Black Box warning: “Because of the uncertain relevance of the rodent thyroid C-cell tumor findings to humans, prescribe Victoza only to patients for whom the potential benefits are considered to outweigh the potential risk.” Although the marker for thyroid cancer present in patients was high, it was still within normal range, according to the authorities. Still, the only way to find out is to continue ongoing cancer monitoring for the next 15 years (!)
There have also been discussions that drugs like Byetta and Victoza can cause an increased risk of pancreatitis. In response, the drugmakers state: “There is no clear association between this class of drugs with pancreatitis. We know that increased risk of pancreatitis with people with diabetes is three-fold over people without diabetes.” So while there is a warning that pancreatitis is also a risk, no clear cause and effect have been proven.
The Business Case
Alan Moses, Chief Global Medical Officer for Novo Nordisk, explains Novo Nordisk’s POV on Victoza: “Medications for patients are imperfect at best. They don’t treat underlying abnormalities of the disease. There are side effects that are not well perceived by patients: weight gain, hypoglycemia. If patients are already overweight, then gaining weight is the wrong direction. It may further exacerbate their disease state as well. Those issues are some of the reasons why Novo Nordisk decided to pursue this therapeutic area.”
So Novo believes that Victoza is a fix for all those problems? Mr. Moses admits that the company also became interested in working on Victoza because their insulin products are predominately used by people with type 2 diabetes later in the course of the disease. Victoza gives Novo an opportunity to start at the diagnosis of type 2 diabetes, hopefully to extend the ability of a person to use their own insulin. “We provide patients with reliable, efficacious products the whole life-cycle of diabetes, ” he says.
Who Will Benefit?
My own endo shared her initial thoughts: “I’m trying it on new GLP-1 candidates so I can get some experience with it. I try it especially on people whose fasting blood sugar is higher than I’d like (over 100) since I think it works better on fasting blood sugars, though possibly not as well on postprandial BGs. Need more time to get a real feel for it clinically.”
Still new, it may take time before we know how Victoza really works out for people. Anyone out there tried Victoza yet? Or been recommended to do so by your doctor? How have you found it? Please take a moment to share your thoughts in the comments section here.
** UPDATE: June 15, 2011 **
The FDA has just issued a safety warning on Victoza, associated with possible risks of thyroid cancer and pancreatitis. Please see our coverage by clicking here.
When I first began, I always took it in the AM. But after three years, I have been (for the last year) taking it before bedtime. My am sugars are low because of that and despite diet, I always seemed to have exceptionally high am sugar. I know I’d be on insulin if not for V and that would be worse – because I have lots of insulin, I just am so resistent due to weight. I also take Metformin since well, years. However, I don’t know whether anyone knows it or not, but the benefits medically of Metformin are amazing. One thing is it seems to be protecting people taking it from lung cancer among other benefits. The good and bad of any drug, including aspirn, must be weighed according to each person’s needs. I think the warnings for V were right out there and open to all of us from the getgo. My endo said “thyroid cancer and pancreatitus, cancer” So, I scan regularly and go BW quarterly. I also pray God graces my life with good health. The best to all of you. We are all in this together. Ruth
ruth, scan for what? and also, what’s BW? thanks, s.
I been on V for about 3yrs now and I haven’t seen any different I take it in the morning and I have tryed it in the evening, I don’t have any side effect from it, I am going to try taking it at bedtime and see if it makes a different, sometimes i have stop taking it for about 2 months, I haven’t taken it now for about a month. I will start back tonight and see how my BS be in the morning.
within 24hrs of taking V, 148, 102, second day, 102, 110, third day,138 no meds that morning, that’s the results I’m looking for. I will continue to monitor for two weeks, and report to my Dr., will keep you guys posted. Yes I had nausea, but i almost welcome that sick feeling, because I know my sugars are somewhere in check. If I can keep these readings at this level, my A1c should come down from 10.9 to………… be announced. wish me luck!
Has anyone had any problems with their Cortisol level while taking Victoza ? Please advise. Thank you and God bless.
TIRED..BUY FOOD BUT I REALLY DONT WANT TO COOK OR EAT IT..HARD TO MAKE PLANS AND KEEP THEM
Took Victoza (.06) with Metformin (1000mg per day) for about a month. Metformin continued to make me feel terrible! Am tolerating Victoza and it has helped me with weight loss. Yesterday was taken off Metformin (yeah!) and my Victoza upped to 1.2. I am having some nausea on the new dosage, but the Victoza and Metformin lowered my FBS and BG levels to consistently around 100!
I keep reading that people have lost their appetite etc and as I have recently been prescribed Victoza, and so far I have not had any adverse effects, I was wondering how long it was before you lost your appetite and any interest in food?
I have used Byetta, had to stop, it made me to ill. I am now on V for 3 months, tolerating it just fine. I have only lost about 12 lbs. However many other people have lost at least 40 lbs, but not me. I do get the “full” in my stomach very often and I really do not want to eat but of course I have to. My BG is still up and down. One minute I am 110 and the next minute I am 185 even without eating. I also use U-500 Insulin, 12 units 2 xs a day. I cannot take any other meds. I took metformin for 6 years but my kidneys are so bad I had to stop taking that. My last A1C 3 weeks ago was 5.3.
I started Victoza and not to long after my calcium levels started rising. My Dr. did not seem to concerned. I started researching and found out about the probable cancer problems. Since I have been diagnoised with parathyrodism. Still seems not to be a real concern. Since than I have come to the realization that for myself I am weaning off victoza without my Dr. approval. I figure the concern might come in only after I develop Cancer. not going to wait for that. Taking things into my own hands. Stopping Crestor also after i developed diebetes after taking that sometimes think that im job security
I have been using Victoza for about 6 moinths with no side effects other than appetite loss. I have not lost an y weight but am very tired all the time. I am very alarmed about the pancreatic cancer warnings since I have had two relatives who died from that form of cancer.My A1C tests are in the 6.2 range.
I had Victoza for almost two years, taking 500mg of metformin twice a day and 4 mg of Glimepride twice daily. I’m 5″3 and 102-106lbs, didn’t loose weight on V. A1c is 6.0 to 6.5 within this two years from 7-8.0.
Lately, my last two blood works show my calcium level were a little higher than the normal range. On top of it I develope some peas size lumps underskin in my arms too!
I stopped injecting the Victoza last week!
Have you had the “pea size lumps” investigated? I have been on Victoza for more than two years and am recently finding lumps under my skin in my abdomen – not at injection sites.
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Has anyone experienced LOW blood pressure while taking Victoza?
I wish it would bring my blood pressure down. It sure seems to have a lot of different effects on different people.
I have lost 25 pounds since November. Victoza really helps keep my appetite down. My A1c blood sugar was 6.0 this time. My blood pressure unfortunately is still too high. My cholesterol however is perfect. I have been on Victoza since last May and lost a total of about 70 lbs with no discernible side effects.
Yes, I had my doctor check them out and she said they are cysts that
harmless. She told me to call her if I notice size change in them.