New Weekly Type 2 Diabetes Drug Approved

On September 18, the US Food and Drug Administration (FDA) approved the once-weekly injectable Type 2 diabetes medicine dulaglutide (brand name Trulicity), developed by Eli Lilly and Company. Trulicity is a new member of the class of drugs known as glucagon-like peptide-1 (GLP-1) receptor agonists. (Exenatide [Byetta and Bydureon], liraglutide [Victoza], and albiglutide [Tanzeum] 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).

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Trulicity, which is approved for use in conjunction with diet and exercise in adults with Type 2 diabetes, is administered via a single-dose injector pen that does not require mixing, measuring, or needle attachment. The safety and effectiveness of Trulicity were established through six clinical trials, involving 3,342 people with Type 2 diabetes, that showed improvements in A1C levels (a measure of blood glucose control over the previous 2—3 months) in those taking the drug.

The medicine will be offered in 0.75-milligram and 1.5-milligram doses to be taken once weekly, with or without food. (The recommended starting dose is 0.75 milligrams, which can be increased to 1.5 milligrams for those needing additional blood glucose control.) Trulicity is approved for use alone or in combination with metformin (Glucophage and others), glimepiride (Amaryl), pioglitazone (Actos), and insulin lispro (Humalog), and it should be injected into the abdomen, thigh, or upper arm.

The label carries a warning stating that certain types of thyroid tumors have been observed in rodent studies of Trulicity, but that it is not known whether the medicine causes such tumors in humans. The drug 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 use of Trulicity in children, the potential effects of the drug on the reproductive and central nervous systems in young rats, the incidence of thyroid cancer in people using the medicine, the effectiveness of the medicine compared to insulin glargine (Lantus) in treating people with Type 2 diabetes and moderate or severe kidney impairment, and the heart risk for people using the medicine.

Trulicity should not be used to treat Type 1 diabetes, diabetic ketoacidosis (a potentially life-threatening condition marked by a chemical imbalance in the body), or those with severe stomach or intestinal problems, 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 nausea, diarrhea, vomiting, abdominal pain, and decreased appetite.

Lilly plans to make Trulicity pens available in the United States later in 2014.

For more information, see the press releases on the Lilly and FDA websites.

  • Diane Mc

    i would be interested in trying this in place of Metformin to see how it helps me. How do i get on the list?

  • Kenneth Jester

    I would like to test this, I am now taking metformin and Actos…

  • robert fucci

    Would be interested in trying this new medication.

  • Terry Xander

    I would consider trying it.

  • Robert Donaldson

    Cost?

  • Stan Erikson

    I would be interested in trying this drug because I had to quit using Metformin due to a conflict with needed to start a new heart drug, Tikosyn. Metformin worked great to control my blood sugar but nothing else has worked for me, even insulin pens. I have become very frustrated but cannot quit taking the Tikosyn.

  • Joel Price

    I am on 3 different diabetic drugs (1 pill, 2 injectable) I want to be on list

  • Joann Phillips

    If your lipid 6 test shows a negitive sign does that mean that your diabetes is cured or just under control. I dont think it would be cured do you? Even if people have the new drug it would just mean that you can eat more things and not be bloated like I am when I over eat sugar right? I have been on a dietary regimine for about 38 years and have not taken any drugs for it am 84 years old but notice that my sugar is making me bloated when I use the little packs that does or does not have the measured amount of sugar in the packs. The pink stuff maskes me sick because it is so sweet that my brain automatically thinks that I have too much sugar in my body and will get sick. Now my belly is round like a basketball. Do you think I have a mental blockage about my sugar or surcrose intake? Please let me know. Before I was diagnosed with diabetes type 2 I use to drink diet soda. My doctor kept saying that I was wrecking my stomach did that give me my diabetes or was it possibly having intercourse with my alcholic husband who later developed type 1 insulin diabetes?

  • charles e grimsley jr

    i would like to try it. i am on lantus solostar right now

  • Brenda Stockberger

    I would like more information on this drug and the chance to try it

  • Brenda Stockberger

    I would like the chance to learn more about this code and try it

  • Joe

    For those asking to be put on a “list” the drug is supposed to be available by prescription before the end of the year. Ask your Doctor.

    I also believe this class of drug is usually taken along with Metformin, not as a replacement.

    I’ve used Byetta and Bydurion with good results. the main difference between those and this one is that Byetta must be taken daily. Bydurion is a weekly injection, but you have to mix a liquid with a powder and assemble the syringe -not easy if your hands are unsteady. Trulicity is a weekly injection in a premixed, premeasured pen. The main advantage is convenience.

  • sue cummings

    i am on metformin actos, and lantus. i was taking juanuvia, but because of cost i had to quit that. my dr. just increased the metformin instead. my a1c is going up without it though. it was down to 6.7 before now it is 7.2. i would be interested to in trying it, if my dr. says it is ok and cost is not to high.

  • Dianna Mazzoni

    I’d be interested in once a week meds instead of Janumet twice a day!

  • Art

    Thank you for the report, it would be helpful to have options. Presently I take Janumet 2x/day.

  • Allen Robinson

    I am on 3 meds now and not doing too well.I would love to try Trulicity.

  • Elaine

    If it is similar to Byetta, I’ll have to pass as I had all the problems listed in the last sentence while I was on that medication. Suffered through it for 9 months while everyone said it would get better – it didn’t – but I’m sure it would be great if you had no side effects from the drug.

  • Kathy

    I would be most interested in trying this medication.

  • Andrew Van Demark

    Would try for better result instead of victoza

  • Brian McClatchie

    I would like to volunteer to test this medication – I currently take Metformin and Glipicide. As a kaiser Permanente patient, I do not have access to the newer meds for Type II. How do I volunteer for this?

  • A Keesee

    I would be interested in trying Trulicity. I am currently using Byetta which requires 2 injections per day.

  • H. Grant

    I would be interesting in trying it. I am currently on Actos.

  • Mark Brown

    I welcome the opportunity to try something that might actually control my high blood sugar levels. Simply cannot afford insulin any longer without insurance participation.currently taking metformin only

  • James Parish

    This could be a miracle med for me. I am currently taking glipicide-metformin. I also have ulcerated colitis. Between the metformin and miserable side effects of colitis, I seem to be suffering from severe diarrhea several times a week (and any time day or night). I would be very happy to try dulaglutide. Would surely be a challenging test person for Lilly.

  • Sue Breiner

    I would be very interested in trying this, especially since Lily is a neighbor here in Indianapolis.

    I have been on Glumetza but had to discontinue it because of the cost. Metforman and Glipizide don’t quite do it.

    Thanks!

    Sue

  • DeAnna Hook

    I am 57 years old and have had type 2 diabetes for 18 years. I failed the diet, exercise, and oral medication regimen and started on Lantus about 10 years ago. My A1c was still over 11. I have been on an insulin pump for 4 years with Humalog. I check my sugar 4 times a day and am still high. My A1c is down to 8 but I still feel lousy most days. I would sincerely like to try Trulicity. Thank you very much for considering me.

  • Jolinda

    Would this work with Kombigiyze XR? What A1C would be needed to be included in the trials?

  • Chris B.

    I would like to try it. I am currently taking Lantus and Novolog.

  • Stephanie Krebs

    I’m interested in trying this medicine but am concerned about how well it will work since bydureon, which is a once weekly injection, did not work well for me. I am on metformin, Apidra, Lantus and farxiga currently.

  • Leo Collette

    I would be interested if my Primary Care Doctor approved.

  • J. B. Koehrsen

    I’ve been on Metformin, Glipizide, Janumet, Actose, and Humalog at various times, and have not found a regimin that successfully controls my A1C. At this point, I’ll try just about anything that will help get my readings below 7.

  • sharon turner

    I would be interested in a once weekly injection wow wouldn’t it be wonderful to not stick as often

  • Diane Buechner

    I would very much like to try this medication. If you are looking for volunteers, I would like to be one.

  • charlene

    I would be willing to give it a try if cost isn’t a issue.

  • Carol

    I would consider trying this. If it would make my diabetis easier to control, it would be great.

  • Jeannie

    I am very interested in this. However, I take Januvia rather than Metformin because Metformin made me very ill, as was also the case with all females in my family that also are diabetic. I’m still very curious and would like to try, if possible.

  • Jerry

    Sounds interesting as I have hardly any symptoms when it goes high or low and presently with metformin which is hard on my stomach and daily schedule and Lantus each night and hoping for more control

  • Ron Hawkins

    I am interested in trying this new drug to control my type 2 diabetes.

  • Darryl Kersh

    This comment is for James Parish who commented yesterday about having severe bouts of diarrhea several times a week. You might want to have your gall bladder checked out by your Dr.. I had to have mine removed and then had to be put on Prevalite 4grams, because it was still producing too much bile for my stomach to handle, causing bouts of uncontrollable diarrhea.

  • Varena Manion

    I would be interested I am currently taking metformin, amaryl and inkovana

  • Donna

    The side effects are the same as Byetta or Metforim, both of which I’m on right now; so this would not be a problem. I’d be interested into reducing injections down to weekly rather than bi-daily.

  • Juanita Hodges

    I would be interested in trying this new medication. Because for years the only medicine that worked was Actos. But dc want give it to patient anymore….so A1c has been high and they wonder why.need help

  • Chaitanya Doshi

    How can you participate? Do you have any contact info. Thanks.

  • Carol Cooper

    I’d really like to be considered to try this new drug. Right now, I use Novolog (sliding scale) and Lantus at bedtime.

  • AC

    I’d like to try it. where do I sign up?

  • Delores Wilson

    I would be interested in trying this drug

  • Mary Langer

    I would love to try this I am curently using Bydureon and my insurance is not coving this and I can not afford to by this.

  • Sandy Heuchert

    I would be interested in trying this med. I tried some samples of byetta w/good results. It kept my glucose levels w/in 50 points after eating and I had no low blood sugar episodes. I currently take metformin (have for 5 or 6 yrs) & continued it while taking byetta. I don’t have trouble w/early morning fasting numbers. It’s when I eat that my numbers jump all over–am quite insulin resistant. I usually go back down by bedtime. The metformin does a good job with that. My diabetes nurse told me that my pancreas has a good chance of burning out & I may eventually need insulin–something I would like to avoid! I do not have medical insurance until next year (Nov) so can no longer afford the byetta after I used up the free samples. Any help would be appreciated. Thank you. I am nearly 64 & w/be on Medicare next year, Nov.

  • Linda Hempfling

    I think I would like to try If I qualify.

  • joan kellogg

    I would be interested in taking this drug.

  • Karen

    I would be interested in obtaining information regarding this drug. Presently I take metformin bid,novalog flex pen tid and levimer at night. My A1C is still slightly above 7…I usually have been in the 6 range,but since taking arimidex for breast cancer…I am having problems with control at times.

  • Ramona

    I am very interested in trying Trulicity. I used Bydureon for a while, and it worked very well for me, but it is a hassle to mix before injecting.

  • Teresa

    I am interested in trying this instead of my victoza.

  • Crystal Codner

    For those of you commenting, the drug is approved by the FDA already. (This is not for clinical trial recruiment). If you would like to try Tulicity, you need to follow up with your healthcare provider to discuss making changes to manage your diabetes.

    Here is the link information: http://www.trulicity.com/

    The trial referenced in this article is for children.

    For those of us who struggle with diabetes, I hope this provides some relief and improvement to our daily struggles.

  • JAMES CARPENTER

    I would be interested.

  • Joe

    To answer every question posted:

    The adult trials are over. You can’t sign up for a trial any more.

    It’s a new medicine and in its patent period, which means there are no generic versions, so it will be EXPENSIVE if you don’t have great insurance. Even then, you will probably have to pay a hefty co-payment. However most drug companies have reduced cost programs for low-income patients. For example, when my insurance stopped covering Bydureon, AstraZenica sent me a discount card to take to my pharmacy.

    Chemically it’s very close to Byetta and Bydureon, so if you tollerate them well, you will probably tollerate this. If not, probably not. However each medicine effets each patient a little differently. I hope you have no side effects.

    The drug has already been approved and will be available by prescription soon. Essentially, they need to ramp up manufacturing and distribution. You’ll get a prescription from your doctor and buy it at your pharmacy. Once again, there are no more trials or tests to join if you are an adult.

  • Sheryl

    I would be interested in trying this med.

  • karon bochman

    I would be very interested in trying this new drug. Currently I’m taking Metformin 1000 mg 2 times a day. I would appreciate if someone would contact me at the above email address with details on how I might be able to try this new medicine.
    Thank you,
    Karon Bochman

  • linda

    I just started this med hope it works

  • Addrienne Hogan

    When will a generic be available