Diabetes Self-Management Blog

On January 26, pharmaceutical manufacturer Takeda announced the approval of its Type 2 diabetes drug, Nesina (generic name alogliptin) by the US Food and Drug Administration (FDA). It is the fourth drug in a class of medicines known as DPP-4 inhibitors, joining Januvia (saxagliptin), Onglyza (sitagliptin), and Tradjenta (linagliptin). Approved simultaneously with Nesina were the drugs Kazano (alogliptin and metformin) and Oseni (alogliptin and pioglitazone [brand name Actos]).

DPP-4 inhibitors work to lower blood glucose by blocking the action of an enzyme known as dipeptidyl peptidase 4, or DPP-4. DPP-4 breaks down hormones called incretins, which stimulate the release of insulin, slow stomach emptying, inhibit the release of glucagon (a hormone that signals the liver to release glucose), and enhance the survival and growth of the insulin-producing beta cells. With DPP-4 inhibited, the incretins have longer to carry out these actions.

Takeda first applied for approval of these medicines in 2007, a year before the FDA tightened its standards for new diabetes drugs; the agency told the manufacturer that it would have to comply with those new standards. Although Takeda resubmitted the application with expanded data, the FDA twice requested more information on the medicines, most recently in April 2012.

The safety and effectiveness of Nesina were established through 14 studies that involved a total of 8,500 people with Type 2 diabetes. Those taking Nesina experienced reductions in HbA1c (a measure of blood glucose control over the previous 2–3 months) of 0.4% to 0.6% compared to those on placebo (inactive treatment) after 26 weeks.

Kazano was shown to be safe and effective in four clinical trials involving 2,500 people with Type 2 diabetes. After 26 weeks, those taking Kazano had additional reductions in HbA1c of 1.1% over people taking Nesina and of 0.5% over people taking metformin.

Oseni, the first medicine in the United States to combine a DPP-4 inhibitor and a thiazolidinedione into a single tablet, was shown to be safe and effective in four clinical trials that included more than 1,500 people with Type 2 diabetes. Those on Oseni had additional reductions in HbA1c of 0.4% to 0.6% over people taking Actos alone and of 0.4% to 0.9% over people taking Nesina alone.

As a condition of the approval, Takeda is required to conduct five trials of Nesina once it is on the market including one focusing on cardiovascular events, as well as administering an “enhanced pharmacovigilance program” to monitor liver abnormalities, pancreatitis, and hypersensitivity reactions in people taking any of the three medicines. The manufacturer also must conduct three studies of Nesina in children: a dose-finding trial, a standard safety and efficacy study of the drug used alone, and a safety and efficacy study of the combination drug Kazano.

Nesina should be taken once daily and will be available in 6.25-milligram, 12.5-milligram, and 25-milligram doses. Kazano should be taken once daily and will be offered in doses of 12.5 milligrams of alogliptin/500 milligrams of metformin and 12.5 milligrams of alogliptin/1,000 milligrams of metformin. Oseni should be taken once daily and will be available in doses of 12.5 milligrams of alogliptin/15 milligrams of pioglitazone, 12.5 milligrams of alogliptin/30 milligrams of pioglitazone, 12.5 milligrams of alogliptin/45 milligrams of pioglitazone, 25 milligrams of alogliptin/15 milligrams of pioglitazone, 25 milligrams of alogliptin/30 milligrams of pioglitazone, and 25 milligrams of alogliptin/45 milligrams of pioglitazone.

The medicines are expected to hit the market in the summer of 2013.

“Controlling blood sugar levels is very important in the overall treatment and care of diabetes. Alogliptin helps stimulate the release of insulin after a meal, which leads to better blood sugar control,” noted Mary Parks, MD, director of the Division of Metabolism and Endocrinology Products in the FDA’s Center for Drug Evaluation and Research.

This medicine 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). The most common side effects in people using Nesina are stuffy or runny nose, headache, and upper respiratory tract infection. In people taking Kazano, the most common side effects are upper respiratory tract infection, stuffy or runny nose and sore throat, diarrhea, headache, high blood pressure, back pain, and urinary tract infection. And in those taking Oseni, the most common side effects are stuffy or runny nose and sore throat, back pain, and upper respiratory infection. Kazano carries a Boxed Warning for lactic acidosis (a serious condition in which lactic acid builds up in the bloodstream) associated with metformin use, while Oseni carries a Boxed Warning for heart failure associated with pioglitazone use.

For more information about Nesina, Kazano, and Oseni, read the article “Alogliptin Wins FDA Go-Ahead for Type 2 Diabetes,” or see the press releases on the Takeda Web site and the FDA Web site.

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Comments
  1. I HAVE BEEN TAKING JANUVIA/SITAGLIPTIN FOR TWO YEARS AND IT HAS BEEN A GOD SENT FOR ME.

    Posted by bob henderson |
  2. I see that effective Jan 6, 2013 that the actual operation ( not what we guessed) has been researched out in a Science News report on a findings release in Nature from :

    Most-Used Diabetes Drug Works in Different Way Than Previously Thought
    Jan. 6, 2013 — A team, led by senior author Morris J. Birnbaum, MD, PhD, the Willard and Rhoda Ware Professor of Medicine, with the Institute for Diabetes, Obesity, and Metabolism, Perelman School of Medicine, University of Pennsylvania, found that the diabetes drug metformin works in a different way than previously understood. Their research in mice found that metformin suppresses the liver hormone glucagon’s ability to generate an important signaling molecule, pointing to new drug targets. The findings were published online this week in Nature.

    Their work also showed that the metformin was signalling outside the ampk pathway directly to stop liver glucose production.

    Posted by jim snell |
  3. While I was able to glean a little information frpm the article, I found most of it was way over my head. Is there another article on this subject out there that has been “DUMBED DOWN” for those of us who so not hold a Master’s Degree in Medical Jargon? The last part about Metformin totally lost me. I’m not sure what it was saying.

    Posted by Carol Cannon |
  4. Hi Ms. Cannon,

    Thanks for your comment. Because Kazano contains the diabetes drug metformin, it is required to have a “Boxed Warning,” or an alert on the package insert, warning about the risk of lactic acidosis that is associated with metformin use.

    Sincerely,
    Diane Fennell
    Web Editor

    Posted by Diane Fennell |
  5. I’m guessing it will be a while before any of these make it to tier one on my insurance company’s formulary.

    Posted by Joe |
  6. Does anyone know what to do with constant infections I get and it causes my sugar levels to jump all over the chart. I am type 2 and insulin dependent

    Posted by sam |
  7. I have type 2 Diabetes and my Doctor has given me Janumet XR 100-1000mg . I was wondering if there isn’t some other pill out there that I could be on that would do the same thing as this one but a lot cheaper. Even with Insurance I have to pay $100.00 each month. I can not afford this. There has to be something else. Please someone help me. I was on regular metformin,but she took me off it.

    Posted by Sandra |
  8. Carol Cannon ask a most important and germanine question.

    I am an engineer - electronics engineer having watched with instruments all sorts of upper level black box behaviour and specifications and chip adherence and misfires with all sorts of test equipment.

    In diabetes land my rude response is present tools there would do stone henge proud. Not the 23rd century vision espoused by Dr McCoy and Starship Enterprise visions, computers and test gear on its bridge.

    The article I shared backs up what I suspected reading and researching what was seen on the fingerprick caveman machines and cgms that my blood glucose would get worse and far better - drop at response to the effigy cycle of metformin in my blood and that cycle was 2.5 hours up to max strength in blood, last about 2 hours ( spec 1 to 3 hours) and after 1/2 hour let go. This has been consistent and repeatable over the last 3 + years.

    From where I sat that metformin is far more powerful stopping excess liver glucose release at sufficient dose 500 to 700 mg and that the longer period of time that the metformin remains up to strength in blood ( ie stopping liver in its tracks) - the better controlled was my blood glucose ( as long as tight diet and exercise utilized).

    My read as peanut galley observer that Metformin may help reduce insulin resistance and that residual levels remaining in individual cells may be of some assistance but in my body the daily rising and falling of met levels due to immediate doses taken in the blood rising to sufficient levels ( too little does not work -250 mg) while sufficient up to strength dose in blood appeared to have far greater effect.

    This work was born out by Salk and John Hopkins children’s research and now this latest article having proper scientific findings not widespead published tales/nee theories claiming otherwise.

    I was taking metformin doses 4 years before we uncovered this by accident and my sense that the full benefit of metformin is being missed by the failure to understand this latest data/findings and failing to focus on the liver.

    It also explains why my Doctor’s approach to taking metformin led to serious drops in excess glucoe in the blood while taking huge doses once a day or twice a day did not seem to do any good.

    While not putting words in anybody’s mouth, my read was that metformin while not engaging in any obvious chemical reactions in the body has the power to directly overcome failed liver signalling on insulin that is supposed to shut off liver glucose release during fasting and in fact the metformin was doing the job directly correcting the failed signalling. The study done seems to bear that out.

    But hey, I am not the medical researcher/doctor here nor recommending anything to anybody. Anything a person does must be under the direct acre and supervison of your Doctor - your safety officer.

    Posted by jim snell |
  9. I also wanted to add that my experience that massive/large doses of metformin only seem to increase bowl , digestion and side effects while sufficient smaller but high enough to signal liver ( in me 500-700 mg) spread around the clock kept a more even level of met in the blood, stopped massive spiking of metformin and for me really controlled liver glucose leakage much more effectively.

    But here again, that was me, my Doctor and what we learned.

    Posted by jim snell |
  10. Hi Sandra,

    My doctor prescribed Kombiglyze XR. Bristol-Myers Squibb has a ‘value card’ program where you can get it for $10 per month. Check their website at to see if you qualify.

    Lee Williams
    New to Type 2

    Posted by Lee Williams |
  11. metformine seul est et restera là molécules la plus efficace dans le traitement du DT2.traitement doit être initier des le diagnostic .

    Posted by feghoul |
  12. metformine seul est et restera la molécule la plus efficace dans le traitement du DT2.traitement doit être initié dès le diagnostic .

    Posted by feghoul |

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