FDA Approves Weekly Type 2 Diabetes Medicine

On April 15, the US Food and Drug Administration (FDA) approved the once-weekly injectable Type 2 diabetes medicine albiglutide (brand name Tanzeum), developed by GlaxoSmithKline (GSK). Tanzeum is a new member of the class of drugs known as glucagon-like peptide-1 (GLP-1) receptor agonists. (Exenatide [Byetta and Bydureon] and liraglutide [Victoza] are the other members of this drug class.)

GLP-1 agonists work by stimulating the insulin-producing beta cells of the pancreas to release insulin in response to high blood glucose levels. Because of their glucose-dependent mechanism of action, drugs of this class are associated with a low rate of hypoglycemia (low blood glucose).

Advertisement

Tanzeum, which is approved for use in conjunction with diet and exercise in adults with Type 2 diabetes, is administered via an injector pen with a 5-millimeter, 29-gauge needle. In a series of clinical trials known as the Harmony program, Tanzeum was associated with reductions in A1C (an indicator of blood glucose control over the previous 2–3 months) of up to 1.0%.

The medicine will be offered in 30-milligram and 50-milligram doses to be taken once weekly, with or without food. Tanzeum is approved for use alone or in combination with metformin (Glucophage and others), glimepiride (Amaryl), pioglitazone (Actos), and insulin (with the exception of mealtime insulin).

The label carries a warning stating that some medicines in the same drug class as Tanzeum have caused certain types of thyroid tumors in studies with rats, but that it is not known whether these drugs cause such tumors in humans. The medicine should not be used in people with a personal or family history of medullary thyroid cancer or in those who have multiple endocrine neoplasia syndrome type 2.

The manufacturer will be conducting post-marketing trials focusing on the safety and effectiveness of Tanzeum in children, as well as on the incidence of thyroid cancer and the heart risk in people using the medicine.

Tanzeum 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), nor should it be used as a first-line therapy in people who cannot control their condition with diet and exercise alone.

The most common side effects in people using this medicine are diarrhea, nausea, and injection site reactions.

GSK anticipates the medicine, which was approved last month in Europe under the brand name Eperzan, will launch in the United States in the third quarter of 2014.

For more information, see the press releases on the FDA and GSK Web sites.

  • Chaitanya Doshi

    Are there any trials ? I would be interested in participating.

  • Joe Braido, Jr.

    I would be interested in the trials for the drug Tanzeum. I would prefer to inject myself once a week rather than once a day.

    I have type 2 Diabetes and the Victoza that I have been taking for the past 2 years has lowered my A1C and helped me lose over 100 pounds.

    Let me know if I qualify.

  • the_melv

    After years of twice a day injections (Byetta) this is a welcome potential change.

  • Mike

    Sounds great..I hope the tests go well

  • Kathy

    Would be interested in knowing more and might be interested in the trial. I am on Metformin and nightly insulin at this time with an A1c of 7.2.

  • H Molvang

    This certainly merits a serious look and
    consideration. One would need access to the third pphase research results. What a boon for elders who begin to demonstrate the need for minimal home care in order to stay in their home
    environment. What about cost?
    How large was the study and how many participants developed thyroid problems?
    With these answers I certainly would want to have a trail use period. HM

  • joanne

    I would be willing to try this drug.

  • Robert Fucci

    Yes, I would like to try this newly approved medication.

  • Jmes Carroll

    With my doctor’s approval, I would be interested in participating in one of the clinical trails mentioned in the article. Several years ago I was in such a trial for actos and did have some adverse side effects that were mild–swelling of the feet and ankles, but now I see that there are lawsuits.

    A once weekly injection would be helpful as it it easy to sometimes forget pills that have to be taken twice a day as I now do.

  • Paul M. Geyer

    Hello : ) As per the article, I would be interested in the onc e weekly type 2 diabetes medication. Thank you very much.

  • Keith

    This sounds like an interesting alternative for patients that have an issue remembering to take their shots regularly. I would be interested in seeing the efficacy of the drug and I may be interested in trying it myself.

  • Charles Berry

    I would to try something I would only have to take once a week. Sign me up.

  • Diana Fenrich

    Yes, I would be interested n trying this drug.

  • Judy Mullen

    I would love to have diarrahea once a week instead of every day.

    Sign me up

  • Mary Powell

    I currently take Humalog 75/25 25gram twice a day. I would be interested in trying this.

  • Ron Bombard

    I would like to try this new med for Type 2. I need all of the help I can get. I am currently taking two shots of insulin a day. 85 in am and 120 in pm
    Thank you

  • Mike Quesada

    I would like to try this also. I will have to see if this was also OK’d by the FAA as an acceptable medication for pilots and would need to know what the wait time is after being on the medication.

  • Sandi Roy

    Would love to only have to have a shot once a week instead of daily with Victoza. Would love to be in a trial for this

  • Mary Thomas

    A trial of a once a week injectable would be great. I would like to be considered.

  • Joan Y. Miller

    This medication sounds like a great help to those of us who have type 2 diabetes. I would be interested in taking it with the approval of my doctor. Sign me up.

  • Ferne

    Leaving the side effects of metformin would be wonderful. This sounds hopeful.

  • Gloria Pilkington

    I would like to take part in trials. I tried Victoza but it made me dizzy and nausua everyday. If this medicine is only once a week, curious if symptoms would only last one day, instead of seven. Please let me know. Thanks.

  • Eugene

    I would love to get on this trail as well.

    Eugene

  • Janet

    If Medicare or VA will cover cost, I am more than willing to try it.

  • Patsy

    I would be very interested in trying this, but I would have to know if it could cause pancreatic. I took Byetta for several years until I developed pancreatic and thought it was going to kill me so I would not want to go through that again.

  • Bonnie Lu Brehm

    The needle they are discribing for the injection does that have a purple top on it, and if so why couldn’t you use the green top ones I think they are the 3 mm’s?

    Anyway, I’ve tried a few insulin drugs before and would be very happy to try one that you only have to do once a week. As long as that’s the only insulin you would have to take.

    I just was taken off of my metformin, the pills to stop your cravings and the Victosa as it only worked for so long and then didn’t do anything for me. They have me now on Humalog 45 units twice a day.

    Anything that can be less painful is my cup of tea.

  • Fran

    Am currently on Victoza. With doctors approval and cost being covered by study group or Medicare, would be interested in weekly shot instead of daily.

  • Martin Mayer

    Berween insulin, oral medication and blood sugar lowering natural supplements, being diabetic is always on my mind.
    I would welcome a less intense regemine such as a once a week dosage!

  • Jan Duell

    This is very interesting. I would be interested in participating in a trial of this. I am presently suppose to be taking Metformin and glipizide twice daily but the evening dosage of glipizide drops my blood sugar too low frequently, have awakened in the nite to a reading of 40. I usually don’t take the nitetime dosage because of that. If a weekly dosage works that would b great!

  • Carmen Muncy

    I am 55 years old female and been Type II for around 4-5 years, failed Metformin, A1c 9.6 and get check 4 times daily and 6 shots of insulin daily. I will interested in trials if I can get it under control better and help the studies for future diabetics. Thank you. Carmen

  • Doris ladin

    With my doctors ok I would like to try this new shot. How much will it cost and will Medicare cover it?

  • Kathy

    I have been on byetta, victoza, and insulin in the past. I now take metformin and glimperide. Along with bydureon. All of these work for a time and I have lost about 35 lbs, but everything stops helping after a while. I would like to try this if it works and would help me lose more weight.

  • Ron

    I would give it a try

  • R L Burns

    Would be interested in giving it a try.

  • G. Long

    Sounds promising. I’m new to insulin injections and so far, they haven’t helped. Looking forward to hearing more!

  • Richard Lykins

    I would like to try it if it doesn’t have any known side effects.Some other meds I had been given in the past were killing women when I was being treated with it.

  • sandy heuchert

    I would be interested in trying this drug. How much does it cost? Thank you.

  • Mike Sylvestrer

    I have been on 2 types of insulin for the last few years, could be interesting to see if this new med would work for me.

  • Rhonda G

    I would like to know more about this. I am on Metformin and I do not think it does a thing for me at all.

  • Janet kitchens

    I would definitely use this especially once a week.

  • Armando Carranza

    I would like to participate in any trial and give this medication a try. Definately I would much rather inject once a week than what I have to do now.

  • Patti S Short

    Yes I would be interested in trying the new drug that you take once a week for your Diabetics Type 2.

  • Matthew Orvosh

    yes, I would be interested in trying this.

  • Ann Jenkins

    Would love to try this new medication for type 2 diabetes, since I have it. Would like to know if it causes weight gain? Waiting to gear from you.

  • Larry Brobst

    I would be very interested in participating in a trial in once a week dosage.

  • Betty Sebree

    I am on metformin 500mg with each meal and 1000 mg at bedtime. Initially, I lost 50 lbs 4 years ago when initially diagnosed, but I am not in as good a control as I first was and weight is creeping back. Have gained 12 lbs and A1C is up a bit. I will be 70 in a couple of months and still counsel and teach students, so my life is very busy. I am an active grandmother and have much of the care responsibility for a 9 year old grandson who lives with us, Perhaps this could simplify my life a bit while stabilizing my blood sugars and keeping me healthy for a few more years. I would certainly be willing to see if I am a viable candidate for this trial.

  • marsha wellein

    I would be happy to try this once-a-week injection. Let me know when and where!!!

  • Joan Hunnicutt

    Yes, I would definitely be interested in trying this new medication.

  • charles vaughn

    I using Novalog 70/30 pens twice a day. I would like to try this product, with the approval of my Diabetic doctor. Once a week would be a joy.
    Thank you, Charles

  • Deb Schiefelbein

    Sounds like a dream come true. You bet I would

  • Linda Carnicelli

    I would be very interested in participating in a trial of this new med. I have been using Victoza in the morning and Levimir at night for over two years and I would love to be able to decrease my injections by 6 a week.

  • Deborah Lam

    I currently inject both Humalog & Lantus. I would be interested in joining the trial group for Tanzeum with my doctors approval. Once a week is an awesome thought if I’m eligible.

  • Tom Bogan

    I would like to try this. I had been on Victoza until my insurance would not pay for it, but will pay for my Bydureon.

  • Lin Bigknife

    I would be very interested in this trial and would add to my current meds with approval from my doctor. Thanks for the information.

  • Mary Roth RN

    Advances in T2 management are always welcome. I am an RN and I represent Unicity Internation, a company that markets a OTC supplement clinically proven (trial reprints available upon request) to reduce blood sugars, and improve leptin function. This is ON THE CLINICAL SIDE OF THE PDR (look for Unicity Balance)and can be purchased thru me. You may see information at http://www.maryroth.myunicity.com

  • Chris Donoghue

    I’m 62 years of age, w/ an inconsistent sugar count which i check almost daily. My doctor has classified me as a type-2, under no medication, trying to regulate this through diet and exercise. Any information would me appreciated and helpful. Thank you, Chris Donoghue

  • Michael Dunn

    Yes I Would Be Interested I”am Currently on Janumet And My A1C1 is 8.2 and would like to get it down!!

  • Mimi Weitz

    I am very interested in finding out about a once per week medication. Currently I am on a daily medication regimen (as are millions of others) and I think the idea of only having to take medication once per week would be quite an accomplishment. Of course, I am sure that there are going to be prerequisites to be able to participate in such a program, but it would be a dream.

  • Bonnie Lewis

    I would be interested in trying the once-a-week medicine.

  • Terri

    I would love to try it!!!! I use Metformin and Glimepiride as well as low carb eating and exercise. I have done this for the almost 12 years I have known about my type 2.

  • kathleen

    I would also like to be included in a trial of this medicine if/when there is one. Currently taking Victoza (for 3 years) and Metformin. I would really appreciate having to do an injection once a week rather than once a day.

  • Tricia Marlin

    With my dr’s approval, I would be interested in this trial. I am now injecting myself 3 times in the evening, victoza and leveimer.

  • Dennis Lee

    Yes I am very interested in this new drug for Diabetes it sounds very promising.
    Dennis Lee

  • Aminah A.

    What about thyroid goiters? Does medication worsen this condition even if taken once a week? Very interested.

  • Michael Dunn

    Yes I Would Like To Try This New Drug. INow Take Janumet And My a1c1 Is 8.2. Please let Me Know When This New Drug Is Available!!

  • Jackie Melear

    I am interested in once a week injections. I an on 15 units of Lantis and 5 units novolog. I am type two. I am stage 4 kidney disease. Not from being diabetic. Have had Kidney disease from childhood and lost my left kidney when I was 27 yrs. old.I beame a diabetic 6 yrs ago.

  • Julia Heggie

    I would be interested in trying this new drug with my doctor’s approval. I am currently taking glimerapiride and tragenta once a day.

  • John Lopez

    I am very interested in trying this medication.
    I am on metformin twice a day and victoza once a day.
    I keep my diabetes under control and this would help control it even better.

  • Dennis Lee

    I am very interested in trying Tanzeum please keep me informed.

  • Carmen Solis-Muncy

    Yes, please please sign me in. I do not care of the side effect If I am able to control my diabetes and lower my a1c. I prick my fingers 4 times a day to check my levels and I’m taking Lantus twice a day and Aspart 4 times with sliding scale, I failed Metformin and I have been loosing weight and journaling my food intake. Please help me help other too. I volunteer for the trials. Carmen

  • Ardy Ross

    I would never take this drug. I attempted to take Byetta and had such terrible side effects that I thought I was going to die. Discontinued Byetta & tried Victosa with just as bad or worse side effects. The inability to even function throughout the day when taking the above mentioned drugs has convinced me that this family of medications is definitely not for me. I felt that I had been poisoned when taking both meds. Good luck to any who can take this family of medications, but I am concerned what the long term effects will be on those who do take any of the above mentioned drugs. I feel strongly that insulin is a more natural medication & more readily accepted by ones body. Plus, I am sure the cost of the new med will be huge.

    • Mark W

      On Tanzeum now…very sick. I feel like I am being slowly poisoned. Was getting sick with Invokana. Even worse with Tanzeum. Had same problems with Victoza and Bydureon. I want to go back to Glipizide.

  • James Mason

    To have this chemical floating around in your blood-stream constantly can’t be a good thing. First, GLP-1 come as goes quickly as needed. it’s targeted and has a pretty direct route to the pancreas. It doesn’t hang around for a week at a time across the entire body. That’s why with a lot of these type of drugs you get problems with various organs — the GLP-1 like substance isn’t supposed to be there constantly. Second, this isn’t GLP-1. While it my be an agonist for the GLP-1 receptor, it’s not naturally in the body, and the differences between it and actual GLP-1 could be significant.

    Ideally, you want something that is able to turn on real GLP-1 as needed from the right places (which then in short order stimulates the beta cells), then disappears and doesn’t float around the system constantly where it can cause problems. It’s constant systemic distribution that worries me and I would have very significant concerns about a drug like this.

  • Barbara

    I don’t know if I’m type 1 or 2. I’ve never been told. I do know that I started taking a variety of pills to control blood sugar, then started taking insulin when those did not work. The only Dx I’ve seen in my medical record is IDDM. Do you think this new medicine would benefit me?

  • Ronald Goldman

    I would interested in trying the new drug. If it will lower my A1C toward the 7 mark I would be delighted
    Thank you

  • Carol Walker

    The medicines i’m on now dont seem to be working ,so Yes i would try something new. So if its at all possible that i can be picked to try this medicine, then Please pick me.

  • karen

    my left foot is completely numb and some numbness in my right foot. i had a nerve test showing that there is no nerve damage and that sugar spikes are aggravating the nerves and did have back fusion surgery last july so some of it is from the surgery. my a1c is 6.6 but he told me sugar numbers for diabetes should be below 6. many doctors say a1c needs to below 7, but really that’s not acceptable. looking for a med that will help me get my a1c down. would be interested in trying this new drug.

  • Bob Burr

    Taking a pill once or twice a day is not an inconvenience. It becomes a routine. I’d be more likely to forget to take a once a week.

    The only new drug I would take for my Type 2 would be insulin if my control worsened. Too many new diabetic drugs have been proven unsafe over time. No more being a guinea pig for me. I don’t want to pay to be in a trial.

  • Deborah Lankford

    I would love to try this new once a week med for type 2 diabetes. I have had good control using glimepiride and onglazia but had some higher A1c’s lately. I am 62 and want to control my health.