FDA approves Janumet

[Daryl]

from the Houston Chronicle website:

"WASHINGTON — A 2-in-1 medicine to treat diabetes has won federal approval, Merck & Co. Inc. said today.

The tablet, called Janumet, combines a proprietary Merck drug with the older diabetes drug metformin.

Some patients with type 2 diabetes already take metformin and the newer drug, called Januvia, separately. Merck hopes the combination version will make it easier for those diabetics to control their blood sugar levels.

The Food and Drug Administration approved Januvia in October. That drug enhances the body's own ability to lower blood sugar levels. Novartis AG continues to seek FDA approval for a competing but similar drug, called Galvus."

[RobLL]

While there may be special cases where my objections don't apply, I am not impressed. For the most part for something a difficult and idiosyncratic as a persons particular glucose profile and reaction to particular medications one is almost always better off tailoring use of each drug to particular need per time of day and amount. Why lose control of important variables.

[Markm]

There is nothing new in this. To me, the approval of Janumet is more evidence of the lack of promising drugs in the pipeline. Big Pharma is re-packaging and tweaking existing drugs so that they can take out new patents and withstand the threat of generic alternatives.

Mark

[RobLL]

Markm - and I didn't mean my post a a criticism of you. I think it was something needing posting, and if anyone out there has experience with both or similar drugs would like to hear their opinion. Rob

[Daryl]

I tend to agree that drug-combining might not be the best way to tackle a problem, at least in a large percentage of cases; I posted the information simply because I think more knowledge is preferable to less.

Januvia has worked great for me (but how much is the drug, and how much is my diet??). I told a friend about it, and she got her mom to get a perscription for it, and she said the difference is like night and day. No more wild blood sugar swings, and she says her mom is acting like the woman she knew years ago.

My morning blood sugars from the last week:

75, 88, 81, 81, 80, 79, and 82. It's been that way for a couple of months now. I use an Accu-Chek Activa monitor, the only one Dr. Bernstein advocates. (I know that because I called his office lol)

Hey, it's a new drug, and some horrific things may come from it years down the road, I have no way of knowing, hence my desire to totally become med-free :) .

[dina1957]

I tend to agree that drug-combining might not be the best way to tackle a problem, at least in a large percentage of cases; I posted the information simply because I think more knowledge is preferable to less.

Januvia has worked great for me (but how much is the drug, and how much is my diet??). I told a friend about it, and she got her mom to get a perscription for it, and she said the difference is like night and day. No more wild blood sugar swings, and she says her mom is acting like the woman she knew years ago.

My morning blood sugars from the last week:

75, 88, 81, 81, 80, 79, and 82. It's been that way for a couple of months now. I use an Accu-Chek Activa monitor, the only one Dr. Bernstein advocates. (I know that because I called his office lol)

Hey, it's a new drug, and some horrific things may come from it years down the road, I have no way of knowing, hence my desire to totally become med-free :) .
Daryl,
januvia so far works great for me, doing that metformin could not : lowred mhy FBG and keep my day time number in low 80s. But I have read that DPP-4 inhibitors suppresss immune system, so there may be pay back. it caused liver carcinoma in rats when high doses administrated in high doses, but not in mices. Any medication: diabetic or not, has side effects on liver, kidney, etc. and there are very dangerous drugs on market already.
But for me, there is no more illusion to get by without meds, weight loss and very low carb diet did not make big difference for me, and almost 5 years of constant struggle and stress wre not worth it.
JMO and JME

[dina1957]

While there may be special cases where my objections don't apply, I am not impressed. For the most part for something a difficult and idiosyncratic as a persons particular glucose profile and reaction to particular medications one is almost always better off tailoring use of each drug to particular need per time of day and amount. Why lose control of important variables.
RobLL,
There are already few medications than combined metformin (or same mechanism of action) with sulfos, adding metformin to januvia won't make muich difference, since januvia has barely any side effects. Side effects of metformin are very well documented, this drug has been on the market for a long time. But combining 2 together may cut the cost (janivia is $5 a pill once a day), and it will be easier to take fewer pills a day. Those who already take metformin, will only benefit on adding januvia. Those who can't tolerate metformin, won't.
I believe they studied Metformin well enough, so is no longer a variable, so there is only januvia which is different class of inhibitors.
JMO

[dina1957]

There is nothing new in this. To me, the approval of Janumet is more evidence of the lack of promising drugs in the pipeline. Big Pharma is re-packaging and tweaking existing drugs so that they can take out new patents and withstand the threat of generic alternatives.

Mark
It depends what you define by "promissing drug". Diabete is such a complex and multifactoral illness, and no 2 diabetics are alike. Keep in mind that not all diabetics have the same underlying cause, so they try different routes to tuckle the end result - keep Bgs at normal range and lessen pancreatic burden. Hence, there are new class of drugs, that restores Phase I response, keep hepatic glucose manufacturing in check, and these two issues assure that Bgs will not spike to a very high level and insulin will be released immediately and much smaller quantities will require. Of course, this only true with adequate diet and exercise regimen, and only if one has still functional pancrease with enough remaining betta cells.
But there is always insulin avaialbe for those who want something "natural", so IMO, they do their best. Ultimate advanture, is to try betta cells transplantation, and could be in near future it will be possible even for T2.
I believe Big Pharma working very hard to find a suitable drugs for T2, after all, they soon will declare entire US population diabetics consider they keep lowering the limit.
JMO

[eddiemcm]

"januvia so far works great for me, doing that metformin could not : lowred mhy FBG and keep my day time number in low 80s."
Dina,are you still using Januvia?
Some of your more recent posts gave me the impression that you may have stopped using it.
Regards
Eddie

[dina1957]

"januvia so far works great for me, doing that metformin could not : lowred mhy FBG and keep my day time number in low 80s."
Dina,are you still using Januvia?
Some of your more recent posts gave me the impression that you may have stopped using it.
Regards
Eddie
Eddie,
I am still on it, just switched from taking it in the am to pm. I always see 20 points FBG spike when my female hormones cycle, so I decided to take it at night.
This morning FBG was 113, not bad for me. Overall, after initital few days of real drop , I think it does work, and is much better to see morning numbers around 110, rather than 130-150 prior to it, so it is quite a change.
I also eat normally (for me at least) : 3 small fruit a day, some bran-a-crips crackers, veggies, salads, some beans, 1/2 cup of oatmeal sometimes, and even 2-3 fingerling potatoes once or twice a months with dinner. I am not overindulging still, no sweets, desserts, pasta, etc, but it gives me more options for breakfast and variety of food to eat, I grew so tiredof eggs, that I have to force myslef to eat 2 eggs weekly.
I will get another H1C in 3 months, and see what my average BGs run, so far it was 110, mostly because of high FBG. I also suspect that my Bgs ran higher during night as well, this is why I decided to take it after dinner instead of morning.
Overall, I am very pleased with positive changes and especially with the fact that I have no side effects whatsoever on januvia, and it is convinient once a day pill in addition to eating variety of food. I also love the fact that it I did not gain weight on this med.
Regards,
D.

[eddiemcm]

Thanks for the info,Dina.
After I run the gauntlet with the sulfys,I was
thinking of starting Januvia.
I used to take 15 herbal pills a day for marginal
BG control-too many darned pills!
Regarding the sulfys,I've oscillated between glyburide and glimepiride-finally settled on
glimepiride.Glimepiride is newest sulfy-only 10
years old.Actually lost a little weight but I'm
developing reservations about sulfys.
Bye for now
Eddie