First-in-Class Drug for Type 2

On March 29, the US Food and Drug Administration (FDA) approved the diabetes drug Invokana (generic name canagliflozin) for use, in conjunction with a healthful diet and physical activity, in adults with Type 2 diabetes. It is the first drug in a new class of medicines known as sodium glucose cotransporter 2 (SGLT2) inhibitors.


In the process of filtering the blood, the kidneys typically reabsorb all the filtered glucose and return it to the bloodstream. One of the main proteins responsible for this reabsorption is SGLT2. By inhibiting the action of SGLT2, Invokana blocks the reabsorption of glucose by the kidneys, promoting a loss of glucose in the urine and lowering blood glucose levels.

The recommended starting dose of the drug is 100 milligrams daily, taken before the first meal of the day. In certain people requiring increased blood glucose control, the dose can be increased to up to 300 milligrams daily.

The safety and effectiveness of the medicine were established through nine clinical trials, involving more than 10,285 people with Type 2 diabetes, that showed improvements in fasting blood glucose levels and A1C levels (a measure of blood glucose control over the previous 2–3 months) in those taking Invokana. Clinical trials also showed a reduction in body weight and systolic blood pressure (the top number) in people using the medicine.

The FDA is requiring five trials of Invokana once it is on the market, including one focusing on cardiovascular events; an “enhanced pharmacovigilance program” to monitor malignancies, serious cases of pancreatitis, severe hypersensitivity reactions, photosensitivity reactions (sun allergy), liver abnormalities, and adverse pregnancy outcomes; a bone safety study; and two studies looking at how the drug works and how safe and effective it is in children.

This medicine has been studied as a stand-alone therapy and in combination with Type 2 diabetes treatments such as metformin, insulin, Actos (pioglitazone), and drugs in the sulfonylurea class. It should not be used to treat people with Type 1 diabetes, diabetic ketoacidosis (a potentially life-threatening condition marked by a chemical imbalance in the body), severe kidney impairment, end-stage kidney disease, or those on dialysis. It is not known whether Invokana is safe in children under 18 years of age.

The most common side effects of Invokana are vaginal yeast infection, urinary tract infection, and increased urination. Because of its diuretic effect, Invokana may also cause postural hypotension, or sudden low blood pressure upon standing; this can cause symptoms such as dizziness or fainting, which are most common in the first three months after starting the medicine.

According to an article in The New York Times, the drug will have a wholesale price of $8.77 per tablet, which manufacturer Johnson & Johnson says is competitive with that of some other diabetes drugs.

For more information about Invokana, read the article “FDA approves Invokana to treat Type 2 diabetes,” or see the official press release or the Invokana Web site.

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  • jim snell

    This is interesting news. We are seeing development of yet another tool that will provide a toolkit of tuning items to the Doctor.

    My concern is that much current thinking and clatter attempts to treat type 2 as a monolithic simple disease always looking for the unified field theory of drugs to solve it. One pill and/or one shot and one is done.

    Nothing could be further from the truth as we are dealing with a multi organ/multi-hormone chemical plant that may require a quiltwork of tuning to achieve nirvana.

    The insulin centric type one model and its research work has helped work some of the initial key issues but overlooks the role of liver, kidneys, digestion, and muscles and glucose storage capacity of the skeletal muscles that impact type 2 along with exercise and energy eaten.

    I am glad we are making progress – no complaint. The sooner we start treating and analyzing this cpmplex plant as it really is sooner, better and in real time, the sooner we will resolve, identify and correct the issues leading to the explosion in type 2 numbers.

  • Susan Palmer

    My concern besides the above comments is that I will never be able to take advantage of any new drugs. I am disabled and because I worked for the government the last 5 yrs before I became disabled I do not qualify for social sec. disability, they also take away all the monies I paid into social security for my life time of work in the private sector and to make it worse my husband died 5 months after I started work with a government agency so that entitles social security to take 2/3 of what I should be getting his widow since they say “he was alive while I worked for the government the last 5 yrs of my work history”. So essentially all of his money he paid in throughout his career is given to others on social security; and I end up with $330 to live on from social security and a very small pension of $1150 a month from the government since I was not a long term employee. So now, after working all my life, I am left like so many, many others who are seriously ill and having to decide which drugs I can do without because I can no longer afford all of them. The topper is that social security says that I make too much money to qualify for any further monetary assistance! In reality, they can create all the drugs in the world to help a diabetic but someone in my situation will never be able to be helped by these over priced new drug therapies. While I am glad they are making great strides in developing new drugs to help diabetics, it is too little, too late for people in my situation.

  • Mary G

    I agree with Jim…
    My initial thought was..”oh,no. Another experiment on us poor diabetics. So many drugs are rushed to the public and it’s years before we find out the harm they can cause. Take for instance. Januvia…very expensive and can cause pancreatitis and wear out your poor pancreas to boot! I got off this drug when I started to feel stomach pain after using it for only two years. I hope there’s no permanent damage.

    There is not enough push from our doctors in general to change our lifestyles. I know, easier said then done! But the idea that drugs are the answer for everything is wrong minded…take a drug and you can eat anything mindset.

    Everyone must make a choice, but education on nutrition should be the first step to a healthier life and outcome. Cut out sugar and focus more on what is making you insulin resistant.

  • ingrid

    So J and J wants to cash in on more Diabetes Management…this one is going to send you to the washroom 8 times a day to expel the sugar.
    It probably is not on an Medicare coverage.
    so what happens when 6 months from now it becomes associated w/ pancreatic cancer. The FDA will apologize and CONSIDER recalling the drug.
    I got tired of these meds that do not work and inject insulin before each meal.Its just as easy as taking a pill.
    there will NEVER be a cure…there is too much $$$ to be made on “management” and no pharma company has any efforts to cure it.

  • Judith Volpe MD

    all diabetes drugs except Metformin have a real darkside. It will be 30-40 years before we finally know ALL the side effects of this one. As a general rule, I never recommend anything that’s been out less than 5-7 years.

  • Khoi Lam

    I haven’t more on this drug expect for what I’ve read here, but if the drug blocks the glucose-sodium cotransporter, what does it do to the serum Na levels?

    I assume the drug is an extended release type since it’s only taken once daily before breakfast. So it acts all day to block the absorption of glucose at the cotransporter, but what about the sodium? Admittedly, we can all decrease our sodium intake, but can it be too much sodium blockage?

    I am curious to see the incidences of arrhythmia and muscle cramps.

  • Khoi Lam

    I agree with Jim on the comment that drugs just focus on the exterior problems of diabetes, such as sugar and insulin. The real problem in patients with insulin-resistant diabetes is the body’s inability to handle insulin. The WHOLE body. This is a whole system problem and therefore the treatment must first start from whole system. Yes, doctors will always tell patients to use medication in conjunction with diet and exercise, but how many patients do these things? Our healthcare system needs to have a way to promote and endorse “diet and exercise” first and have a solid way of following up.

  • Ferne

    I have a concern also about the cost of a new drug and the insurance I have will only pay for what they think a person should have and not what the doctor orders. That is frustrating when only one med works but isn’t covered. It’s hard to excited about a new drug with such side effects, cost (8.77 is very expensive for me) and we don’t know how it will affect us after taking for awhile.

  • Andi Schneider

    It is astonishing that a medication like this was ever thought to be a good idea. When I was first diagnosed with diabetes I had been flushing a lot of glucose into my urine as my kidneys attempted to rid my body of it. As I learned how to manage this new disease, I was taught that taxing the kidneys in this way would lead eventually to damaged nephrons, the micro-tubules and network of blood capillaries that filter such toxins. It seems logical that a medication that stimulates the kidneys to do this on a continual basis will cause them to wear out earlier. All diabetics need to treat their already over-worked kidneys with care. Good blood glucose control can spare and extend the longevity of a diabetic’s kidneys; can these drugs do the same?

  • Mary G

    As Ingrid pointed out…all those trips to the bathroom. This can’t be good…what harm is Invokana going to do to the kidneys? Will this hasten the need for dialysis? Untreated diabetes already spills excess sugar into the urine.(I had no sypmtoms of diabetes except for a routine urine test revealed a high level of sugar and a yeast infection.) So, this pill will do the same thing, only costing $8.77 for each tablet or $263.10 a month. Doesn’t make sense to me! I will skip this drug…

  • MRG

    Since I got diagnosed with diabetes type 2 3 years ago I’ve been lucky to be able to control it with diet and exercise and have known people who were much heavier than me to have done the same through programs such as Overeaters Anonymous. I feel blessed to not have to take these drugs and angry that the first thing my doctor said was that I had to get on a drug. I refused and was able to do it without them. When I slip and my glucose levels get high I go back to my support system (including a 12-step group) and have been able to get back in control. It’s not easy, but it’d doable and if our society were not so focused on money-making drugs and the focus were on healthy eating and exercise things would be much better for all of us, diabetes or not.

  • Barbara M

    From everything I have seen and read, there is only one thing that comes close to possibly being a cure for all of us and that is the one thing everyone is afraid of talking about… Stem cells ! they can be taken from your own body and grown and be implanted lanted in the pancreas and are virtually an instant cure for this damned disease ! THe only other thing that comes close is the operation for obese people that puts the band around the belly so they lose the weight very quickly to where for many of them the Diabetes disappears……..

  • maggie m

    i started going to a diabetic dr a month ago. i am on lantus, gliperzide, and metformal. Dr wanted me to take a shot once a week. it is called bydureon.after talking to my pharmacist and finding out after insurance it will cost me $400 a month or 4 shots. I cant afford to do this. any suggestions???

  • geoffrey fulton architect

    The greed, deceit and corruption by the big parma companies make me suspicious of anything they or my doctor recommends. I take the prescriptions, don’t take the drugs, recently went to my GP for a check up. told my Diabetes was now well under control with the metformin he prescribes that I don’t take. I am in a university study for a new drug. I accept the testing but don’t take the drug. Have now found that it is banned in the USA but the drug company is still testing in Australia and obviously going to try to market it here!! Glad I didn’t take the drug. BUT I am eating a very good healthy food regime, am losing weight. So healthy eating is the best drug for everyone.

  • Shelly

    I have just been taken off of the Bydureon. Was not working. Left hard lumps at every injection site. And my A1C went up. I insisted on going back to Metformin. Back to basic meds. I am very careful with my diet and exercise. I was able to stay off of meds for several years by doing so. I do agree doctors are too quick to perscribe medication.

  • Stephen Hunter

    I have just switched to Metformin ER. The information sheet that came with my RX states that the drug should be taken with the evening meal. How important is the time I take the pill? It is much easier to take the pill with breakfast.

  • Melissa Wilson

    Hi. I am a 32 year old female with type 2 diabetes. On April month of this year(todays April 28th), I was hospitalized because my blood glucose level was 450 and my A1C was above 12. I’m still so sad and scared. I was sent to a nutritionist who put me on Metformin and Levimir. She is trying to eventually put me on that new injection which a few of you mentioned…the one that gives you a welt and releases insulin as your body needs it. I was doing fine on my Lantus and Humalog which are the medications I was given by the hospital upon release. My Dad is insulin dependent and said his doctor tells him to, “save the new stuff for other patients”. And that insulin is the only diabetics medicine he used because it is something naturally produced by the body. I have an appointment with my nutritionist tomorrow. I do not think I’m going, instead I will find a regular doctor or a diabetic specialist. Please give me your thoughts and opinions! Also, I was was thing my entire life up until during and after my second pregnancy(4years ago). I did not know diabetes could develop that quickly. Please comment, I need advice. That.I you.

  • Melissa Wilson

    April 9th(not month), and I was thin…not ” thing”. Sorry, auto correct.