New Diabetes Drug Tradjenta Approved For Type 2 Diabetes

WASHINGTON -- The Food and Drug Administration has approved a new diabetes pill from Boehringer Ingelheim and Eli Lilly for patients who can't control their blood sugar with older medicines.

The agency said Monday it approved Tradjenta tablets for adults with type 2 diabetes. Type 2 is the most common form of diabetes, affecting up to 95 percent of the 24 million people in the U.S. with diabetes.

People with the disease have trouble breaking down carbohydrates, because their bodies have become resistant to the protein insulin. They are at higher risk for heart attacks, kidney problems, blindness and other serious complications.

Tradjenta works by blocking the DPP-4 enzyme, which releases insulin-boosting hormones that help control blood sugar levels. Merck & Co. Inc. and Bristol-Myers Squibb already market similar drugs in the U.S.

Merck's Januvia pill had sales of $954 million last year. Diabetes drugs accounted for $16.9 billion in U.S. sales last year, according to health care data firm IMS Health. The drugs made up the fourth largest prescription drug class by spending, behind cholesterol drugs.

The FDA approved the new medication as a stand-alone treatment or in combination with older diabetes drugs like metformin. Many diabetes patients have to combine drugs to manage their blood sugar levels.

Boehringer and Lilly submitted eight studies of the drug that enrolled more than 3,800 patients. The drug consistently improved blood sugar control when compared to placebo.

The most common side effects of the drug were respiratory infection, sore throat, muscle pain and headache.

Tradjenta, known by the generic name linagliptin, will be distributed with a medication guide explaining the drug's risks to patients.

FDA issued new testing guidelines for diabetes treatments in 2008 after data suggested that GlaxoSmithKline's diabetes pill increases the risk of heart attack. That drug, once a blockbuster medication for the company, is currently only available through a limited prescribing program.

Boehringer is headquartered in Germany, with U.S. offices in Danbury, Conn. Eli Lilly & Co. Inc. is based in Indianapolis.

Comments

[froidytoidy]

08:57 PM on 05/04/2011

Wow - so many comments lack empathy for the diabetic...it's a though people decide they want to be diabetic and eat like a pig. Sorry, but there are many disease states and medications that exacerbate weight gain, lethargy, and make it difficult to exercise properly.

There are over 100 different types of neuropathy, and only a few are from diabetes. Medications such as Gabapentin for neuropathic pain, steroids, and antidepressants can cause significant weight gain. People have no knowledge of what causes a person to balloon up - so why and the heck is everyone so judgmental?

Regarding the new diabetic medication: I'm predicting a black box warning and once again, withdrawal from the market. Congrats. to those who own stock

[therightzwrong]

05:50 PM on 05/04/2011

I get a sense from replies of my posts on this board and from reading pages of other posts that some people will become diabetic just because they are stubborn and rigid. They refuse to accept that in order to be healthy one would have to eat foods that are not processed, exercise and stay away from complex carbohydrates.
You want to stay fat and tired.. by all means.. you do that.. it's a shame I have to support your food addictions and lousy exercise ethics in my insurance premiums.

[theblueAmerican]

12:03 AM on 05/05/2011

Sorry to break your bubble but some people like me are predisposed to being a type 2 diabetic due to genetics. Sure, the food you eat and the amount of exercise you do play a strong part but I would still be a type 2 diabetic. On top of it the way we have to manage our daily lives in this age and all the processed foods marketed to us don't help. Not impossible but tough especially the less money you make. Type 2 diabetes would not be in epidemic numbers without some help from companies that push bad foods. Have some compassion, you never know when yours or someone you love has a genetic makeup that makes them susceptible to health issues.

[therightzwrong]

07:27 AM on 05/05/2011

Yes. I am fully aware of the genetic disposition. Some are not genetically provided with the means to store/metabolize sugar in a healthful way. My Dad is diabetic, was diagnosed when he enlisted in the USAF at age 18. Insulin for him on and off since then. Still, diet and exercise have helped him. My Dad does seem to crave more sugar than the rest of us do.. he sneaks bagels and cookies. Then he pays for it by becoming irritable, tired and listless. It's sad to see.. The Paleo diet has helped me and my sisters.. All of us now in our 40s.. None of us with elevated sugar. Interesting that our Mother is 100% scandinavian, descended from Norway/Sweden. Her parents never had cholesterol issues or high sugar levels and lived into their 90s. I bet her ancestors consumed much more EPA/DHA than my father's slovak ancesters did.. (both of his parents diabetic)

[AmericasPharmacist]

04:50 PM on 05/04/2011

I actually wrote the book on diabetes, It's called "Diabetes Without Drugs" and how one can reverse this condition and cure it, naturally. My book is used/recommended by the worldwide doctor's organization called "A4M" The American Academy of Anti-Aging Medicine.It took a some time to find natural remedies that actually spark production of new beta cells, and improve mitochondrial function (the heart of healing) and among others, curcumin, resveratrol, citrulline and spirulina. This "new" diabetes drug belongs to the same class as others on the market, such as Januva, Galvus, and Onglyza. These drugs block DPP-4 but YOU NEED THAT enzyme to slow down development of cancer! Will we have to connect tragic dots one day? This class of drugs also increases risk of infection too. Suzy Cohen, RPh

[AllieGoogle]

04:43 PM on 05/04/2011

For all the folks putting out the nonsense that all you have to do is be fit and healthy to cure Type II diabetes - BOGUS

some portions that prove you wrong:

Type 2 diabetes is believed to have a strong genetic link, meaning that it tends to run in families. Several genes are being studied that may be related to the cause of type 2 diabetes.

Ethnicity: Certain groups, such as African Americans, Native Americans, Hispanic Americans, and Japanese Americans, have a greater risk of developing type 2 diabetes than non-Hispanic whites.

# Aging: Increasing age is a significant risk factor for type 2 diabetes. The risk of developing type 2 diabetes begins to rise significantly at about age 45 years, and rises considerably after age 65 years.

http://diabetes.webmd.com/guide/diabetes-causes?page=2

[DrP]

10:29 PM on 05/04/2011

Insulin resistance is genetic. It is the result of the fact that many human populations have not evolved to handle the glut of carbohydrate/glucose in the modern diet. That is why the groups you mention are particularly susceptible - the closer to the native diet being that of the hunter-gatherer and the more recent the introduction of agriculture and a high-grain diet, the more likely a population is to be insulin-resistant. The symptom that we call "Type II Diabetes," that is, high blood sugar, is not. Insulin resistance cannot be "cured," but the symptoms can be easily managed. I know because my family is severely insulin resistant, but my generation and my children are avoiding high blood sugar and insulin levels by following low-carb diets and staying active.

[Ichigo Kurosaki]

02:20 PM on 05/04/2011

There will NEVER be a cure as long as there is so much money to be made from these palliatives. I remember how Big Pharma suppressed a cure for 98% of ulcers, until they got their drugs made OTC (Tagamet, Zantac, Pepcid and Axid). Two weeks after Tagamet went OTC, the cure got "announced".
The same thing will happen with diabetes and cancer.

[theblueAmerican]

12:18 AM on 05/05/2011

no

[farmilyman]

10:32 AM on 05/04/2011

It's far easier and safer to just stop eating junk

[AllieGoogle]

04:31 PM on 05/04/2011

A simplistic answer from someone uneducated. You can eat properly and still have diabetes - and still have glucose control issues. And yes, I have Type 2 diabetes, insulin dependent, genetic cause

[ThinkCreeps]

04:39 PM on 05/04/2011

You are in the minority of type-2 sufferers. (Unless you're also 400lb.)

[DrP]

10:30 PM on 05/04/2011

I am very confused. "Type II Diabetes" is by definition "non-insulin-dependent diabetes." So you can't be Type II and insulin dependent.
What sort of diet are you eating?

[CountryBeforeParty]

10:27 AM on 05/04/2011

I stop using the meters because, as others have said, it's become so expensive to get the strips. Frankly I know what I'm doing right and wrong. I know what I'm eating and adjust accordingly. I know when I'm active and not active.

I can't let this stuff bankrupt me.

[AllieGoogle]

04:33 PM on 05/04/2011

As someone with Type 2 I can say this - that's a recipe for disaster. You'll find out when you land in the hospital with out of control glucose that has already severely damaged your kidneys and/or eyes or other vital organs. Even if you maintain your exact same patterns - your pancreas will continue to get worse - requiring changes in food/diet/meds

[DrP]

10:34 PM on 05/04/2011

I do not test either. But I never have. Nor have I actually been diagnoses as "diabetic." When I finally understood in my late 40's that my slowing advancing symptoms were increasing problems with my blood sugar and insulin levels and learned about the efficacy of carbohydrate restriction, I changed my diet and have never had an abnormal blood sugar reading because of that. I have such strong symptoms when I inadvertently consume carbohydrates beyond what my body can handle, that it is easy to know what I can and can't eat.

[smrgurl25]

11:59 PM on 05/03/2011

It's time for improved, new treatments for TYPE 1 diabetes. Everything is about Type 2. Type 1 has nothing to do with lifestyle, weight, etc, it's autoimmune. I have been taking insulin for 41 yrs, since I was 5 yrs old and I get so mad at all of the strides made in DM 2. I understand it is easier to study b/c it is so lifestyle influenced and 2's still make some insulin. Type 1 is much more complex. Type 1's will never get off insulin and many of us take 6 or 6 injections per day as well as the same amt of blood testing with finger sticks. Type 2's don't turn into 1's just b/c you start insulin as many believe. Once a 2, always a 2. 1's can't just lose wt or start exercising or have bariatric surgery to resolve our type of diabetes. More research funding needs to be put towards to Type 1!! I will trade my 1 for Type 2 anyday.

[therightzwrong]

07:11 AM on 05/04/2011

Yes.. you are right.

[stape45]

10:07 AM on 05/04/2011

If there were an actual CURE, it wouldn't be available in America, because the profits are in the treatment.

[DrP]

01:17 PM on 05/04/2011

I am on a campaign to eliminate the term "Type II Diabetes" from the lexicon. In my opinion, Type I Diabetes should simply and solely be "Diabetes."
What we call Type II is something completely different, is not a "disease,
but a symptom of improper diet in those of us who have genetic insulin resistance. Our condition is "insulin resistance" and it is very easy to manage with a low-carb diet. When the symptoms of improper diet arise, high blood sugar and insulin levels, and these symptoms are called "Type II Diabetes" and treated a medical condition to be addressed with pharmaceuticals and, worst of all, insulin injections, the poor "victims" of this medical intervention are doomed. I know, because I saw it happen to many family members. Thank God my siblings and I , and now my children, understood that diet is the key to managing our insulin resistance and we will never have to suffer the complications that befell my father and grandfather who were "Type II Diabetics."

[AllieGoogle]

04:35 PM on 05/04/2011

Totally bogus. I'm Type 2 and even if I do everything perfectly - I still need insulin - and will continue to need more and more as my pancreas finally stops producing any insulin.

[theblueAmerican]

12:25 AM on 05/05/2011

I look at type 2 diabetes as heart dsease. controlling your blood sugar is only part of the equation.

[soto4real]

11:25 PM on 05/03/2011

I have tried almost every drug in the market for type2, i get tired of companies trying to pass a different meter, and charging them to the inssurance company. The best I have tried was a proper balance diet exercise and everything in moderation to beat the stress. These drug companies are the main reason our healthcare is in the mess it is today. i don't mind poking myself every once in the while if it saved my life. i can eat almost anything and never had a problem keeping my sugar at bay.

[DrP]

09:50 PM on 05/03/2011

"People with the disease have trouble breaking down carbohydrates, because their bodies have become resistant to the protein insulin. They are at higher risk for heart attacks, kidney problems, blindness and other serious complications."
This says it all. The insanity of current "diabetes treatment." If our bodies can't break down carbohydrates, then we need to stop eating them. It is that simple. Since cutting down to around 20 to 30 grams of carbs in the form of non-starchy vegetables 11 years ago, I successfully turned around the slow march to the terrible condition that destroyed my father and grandfather who were treated with meds and insulin. Low-carb diet, no medications necessary. It is really that simple. If the medical establishment would treat so-called Type II Diabetes for what it is, the inability to utilize carbohydrates due to insulin resistance and treat the underlying cause instead of the symptom (high blood sugar), with a low-carb diet, then this so-called disease would be completely eradicated. And giving insulin to someone who is insulin-resistant should be grounds for malpractice.

[AllieGoogle]

04:37 PM on 05/04/2011

-Low-carb diet, no medication­s necessary. It is really that simple.-

No - it isn't. Many on a low carb diet are still in need of insulin

-And giving insulin to someone who is insulin-re­sistant should be grounds for malpractic­e. -

You are insane.

[DrP]

10:40 PM on 05/04/2011

If you are insulin resistant, then your cells can't respond to the insulin signal to utilize the glucose. Why would you give insulin to someone who is insulin resistant? That is insane. Type II Diabetes is defined as "non-insulin-dependent." It is the result of insulin resistance, just as the article says. The answer is not to eat the foods that require insulin to metabolize, since the insulin won't work. Geez.

[theblueAmerican]

12:26 AM on 05/05/2011

DrP is a duck. A well meaning duck but a duck nonetheless.

[SitandStay]

08:24 PM on 05/03/2011

How many landfills does it require to hold just the last year's glucose meters that are now being replaced by a meter with cartoon characters that squawk the blood sugar level or maybe the one that came in another color? The test strips now come with an expiration rate. Funny, I never had a problem with the readings before they started making strips that became obsolete at the manufacturers designation. The test strips are unbelievably expensive considering the low cost of manufacturing them and considering the burgeoning market that grows exponentially every day. Between the manufactured food corporations and big pharma, I doubt we will not see any real improvement in my sons generation nor mine. The pharmacies now have you sign up for diabetes education at their window so your insurance company or the pharmacy can write-off any costs of mailing you a flier under the pretense of wishing you were not a diabetic. Caring about useless and unnecessary manufacturing of plastics that end up in landfills and oceans should stop any entity from contributing to that, but big pharma cares for no one....except the megawealthy stock holders and board members.
I urge everyone to box their spare meters, that do not use their current glucose strips and return them to a manufacturer. I enclosed mine with printouts of each of their board members and what I thought of them. Have a nice day.

[SitandStay]

08:32 PM on 05/03/2011

You do realize that's why they are so willinng to give you a FREE meter, don't you?
It's like a drug dealer, that gets you on their product that you can not get offf, so you will continuously buy their expensive strips.
If you want them to profit even more, sign up for home delivery so you can include another corporate "middle man" that makes money off the tax-payer-funded, government delivery, tax write off system. You are also paying for those commercials because pharmaceutical comrporations are some of the FEW corporations that can afford television air-time in this economy. Lather up.

[stape45]

10:52 PM on 05/03/2011

Over the long haul, that "free" meter will cost plenty.

[foresure]

09:10 PM on 05/03/2011

Reply to SitandStay:

You can buy test strips on-line for half price. Just seach the name of the strip you want. You don't need a presciption. I got deliery in two days.

[therightzwrong]

08:22 PM on 05/03/2011

Stop eating sugar and starch.. Mothers BREAST FEED your babies. RAW MILK if any cows milk for children. VEGETARIAN , VEGETARIAN, VEGETARIAN.
My father is a life long diabetic (dx, 20 years of age) Drank like a fish, ignored all doctor warnings,.. insulin on and off since he was 28. Now, 70 REALIZES and is doing GREAT!!!
Lean meats if any.. NO ALCOHOL, NO SUGAR, NO RICE, NO STARCH. Let your pancreas regroup.. also, if all else fails. Look at Gastric Bypass operations curing diabetes before a single pound is lost! Something in the duodenum that is removed in bypass surgery is causing the malfunction which leads to diabetes.

[MagicManDoneIt]

03:50 AM on 05/04/2011

"Something in the duodenum that is removed in bypass surgery is causing the malfunction which leads to diabetes." I'm not a doctor, but this sounds completely made up. Any citations for this claim?

[therightzwrong]

07:04 AM on 05/04/2011

It's becoming rather old news but here is a link..

http://www.sciencedaily.com/releases/2008/03/080305113659.htm

Here is another.

http://www.npr.org/blogs/health/2011/04/27/135775849/new-clues-to-why-gastric-bypass-surgery-cures-type-2-diabetes

[AllieGoogle]

04:39 PM on 05/04/2011

Total nonsense.

[EdMercer]

08:20 PM on 05/03/2011

Good to see another drug http://www.diabetesinfoguide.info to help with this out of control disease.

[rikster]

07:12 PM on 05/03/2011

I wonder who paid for this article...

[foresure]

06:32 PM on 05/03/2011

I am a senior on Medicare, using Part D. I am also a Type 2 Diabetic. Last year I fell into the "donut hole" If you are going to fall into the "donut hole", or do not have good drug insurance, may I suggest two Google searches tp you:

"Prescription Drug Importation and Internet Sales: A Legal Overview"
By: Jody Feder, Legislative Attorney, American Law Division. The article is a little "wonky", but it is enlightening.

Then Google "Canadian Pharmacies" You will find many sites. I would avoid those that do not require a prescription, or offer free erectile disfunction drugs as a bonus. (I almost wrote come-on!!!)

I have saved hundreds of dollars when I was in the "donut hole, as I will be again in a few months.

The only inconvenience I have experienced is the three week wait for delivery, and the fact the medicine is sent Registered Mail, so you (or someone else) has to home for delivery, or you have to go to the post office to pick up your medications.

I swear I am not in any way associated with any pharmacy. I am merely a consumer. I found a good thing.

THIS IS WELL WORTH CHECKING OUT.

[Ami Munro]

07:47 PM on 05/03/2011

Wal-mart has an OTC insulin (HUMULIN N & R) that are only $25.00 a vial.

[Apelika]

09:02 PM on 05/03/2011

All well and good, but not all diabetics need to take insulin.

[DrP]

09:31 PM on 05/03/2011

If you are type II, change your diet and get off the insulin. No sugar, no starch, no grains and lots of fat. You wont' need meds and shouldn't be taking insulin anyway since Type II by definition is insulin-resistance - meaning that insulin doesn't work in our bodies.