Last week, the U.S. Food and Drug Administration (FDA) approved a new drug for treating Type 2 diabetes. Called Cycloset, the drug is actually a new version of the older drug bromocriptine, which has been used at higher doses to treat people with Parkinson disease.
The new drug, which is to be taken once a day, within two hours of waking up, with food, has been shown to lower HbA1c levels (a measure of average blood glucose) in people with Type 2 diabetes more than a placebo. In a year-long study of over 3,000 adults, 39% of people taking Cycloset reached the study’s HbA1c goal, compared to 11% of people who took the placebo. According to Cycloset’s press materials, studies have also shown that one daily dose of the drug helps lower postmeal rises in people’s blood glucose levels all day.
According to animal studies, Cycloset works by boosting the activity of a chemical called dopamine in the brain. This, in turn, “resets” the body’s biological clock to help control its metabolism. Studies of the biological clocks of migrating birds and hibernating animals, which become more insulin resistant during certain times of the year, helped inspire this drug’s development.
People taking Cycloset in the 3,000-person study were also less likely to have a heart attack or stroke or to die of heart disease while taking the drug. Earlier this year, the FDA tightened heart-safety standards for new diabetes drugs (check out the Diabetes Flashpoints feature “FDA: Stifler or Savior?” for more details about this decision).
When this drug will reach the market is unclear, since its manufacturer, VeroScience, Inc., is a small company. An interesting article about this drug’s 20-plus year journey from laboratory to market appeared last week in The Boston Globe.
I am intrigued. The numbers based on the trial aren’t huge, but it does show interesting possibilities because of the way it works. Another option for those of us with this disease. Thanks VeroScience.
Posted by Lorre | May 20, 2009 at 12:12 pmDoes this “metobolic reset” affect the patient’s weight?
Posted by RWoodward | May 20, 2009 at 2:07 pmAll these new drugs for type 2 are supposed to be great - BUT - I’d like to know how long they tested the 3,000 people - what affect does extra dopamine have on the rest of your body? Does it make you gain weight? What was the A1c number that it was lowered to?
Posted by Phyllis | May 20, 2009 at 2:22 pm7? Many questions before I would even consider taking it - it’s a Parkinson’s drug and that is not a nice disease…….
What are the side effects associated with new drug. How was this drug syntesized? (how is it made and from what material).
Posted by Anne | May 20, 2009 at 2:33 pmThis sounds positive! Did they check to see if it’s tolerable with other diabetes drugs? What are the possible side effects?
Posted by Lois | May 20, 2009 at 2:39 pmHi RWoodward,
Good question! According to this Associated Press article, which was also sent to me by VeroScience, Cycloset did not affect weight in the trial.
Posted by Tara Dairman | May 20, 2009 at 2:48 pmI have been getting spectacular readings when I eat spelt (low gluten). Have had to reduce my evening insulin or I would have low blood sugar in the A.M.
Have there been studies on this item? I note that hummus is gluten free.
Any thoughts, anyone?
Posted by Evelyn Augustin | May 20, 2009 at 4:08 pmThis does sound good if it works the way they say. I’m really concerned because I was on Actos and had to stop I gained so much weight. When I found out I was diabetic, I lost 26 lbs. and now I’ve gained all that back plus.
Posted by Sharon | May 20, 2009 at 5:14 pmI can’t take any of the oral diabetic pills as my body swells. Do you suppose I could take this diabetes pill?
Posted by Pauline Fecht | May 20, 2009 at 6:03 pmSide effects? Only 3000 people for 1 year? Don’t most harmful side effects show up several years later? Need more information before I would be interested in trying it. Life is scary enough without using new drugs that have not been sufficiently tested.
Posted by Jon S | May 20, 2009 at 6:04 pmKudos go out to all fellow Type II diabetics who are right on top of the issues where new drugs are concerned.
Posted by Del Fields | May 20, 2009 at 8:02 pmAfter reading the above comments, I can think of any more IMPORANT, aka life threatening, issues to raise.
I will just say in closing, remember Avandia.
After Avandia was put on the market, I am very scepticale about any new drug. Avandia was supposed to protect your heart, liver, and kidneys but later proved to do the opposite. The FDA needs to address the long term effects of any medications before putting out any new medications on the market.
Posted by Norma | May 20, 2009 at 10:19 pmvary simple question. If this drug works on either stimulating dopamine production or making the body more sensitive, how does it compare to the fact that medications such as Wellbutrin (Bupropion)? That medication is classified as a dopamine re-uptake inhibitor. Should that class of medications not have at least some effect on postprandial blood glucose levels?
If they do work, is anyone doing investigation into using dopamine re-uptake inhibitors?
Wellbutrin also affects norepinephrine re-uptake as well…
It would be interesting for sure. Messing with dopamine levels is a spooky area but if it works, great.
Posted by rkw | May 21, 2009 at 12:30 amHi everyone,
Lots of great comments here! As for side effects, according to the AP article I linked above, the following were found in the study:
“Side effects include nausea and dizziness, sometimes because of blood pressure dips upon standing. Nursing women shouldn’t use it. Bromocriptine inhibits lactation, and although no link is proven, there have been reports of strokes in postpartum women using higher doses. The FDA said it also should be used cautiously with people taking blood pressuring-lowering medication.”
Posted by Tara Dairman | May 21, 2009 at 9:50 amThe drug sounds interesting, but the cost will be too much for many people. Too much markup, too costly. Am I correct?
Posted by william lenzi | May 21, 2009 at 4:09 pmHi, I think the drug is fantastic provided it does not have side effects in the long run as in the case of Avandia and some other similar drugs.
Posted by Shagufta Wajahat | May 22, 2009 at 10:15 amAlso I would like to mention about Gram( a kind of lentil,botanical name:Cicer arietinum)which brings down the PP level by 50-60 points if consumed in place of wheat/rice.I have experimented on myself a number of times and everytime I got the same results.
I am a new diabetic, 73 years old. I am taking Glipazide,(spelling??) I do ok for a while and then about two weeks apart, I get very sick with projectile vometing, and weakness and shaking for several days after. My Dr. doesn’t seem to understand my problem. I have had to hunt for approiate food list, and I know nothing about the regular care. sometimes I can’t feel the soul of my feet as I walk. this is the most mess I ever have been in. where do I get help on total income of 1,200 a month??
Posted by Betty Qualls | May 23, 2009 at 12:38 pmDear Betty,
It’s difficult to know whether your symptoms are related to your diabetes, the drug or drugs you are taking, or some other condition. If your current doctor is not taking them seriously, it may be necessary to find a new doctor who will. The doctor should also send you for diabetes education, so that you can learn more about diet, exercise, and how to take care of your diabetes.
Jan Chait has a terrific article, “Questions for Your Doctor,” with tips about how to look for a good doctor. I hope that it helps you and that you find a good advocate for your health soon.
Posted by Tara Dairman | May 27, 2009 at 9:39 amcycloset is still unavailable in my area as there is no distributor. Can I safely take bromocryptine at the same dosage with the same effect
Posted by susan lesser | Jun 25, 2009 at 1:12 pmCycloset was formulated to provide a discrete time of day dependent exposure to a drug with dopamine agonist activity. The parent compound of Cycloset has been used for 30 years with millions of person years of exposure and the safety is well established at daily drug dosages several folds higher compared the dose of Cycloset needed to treat diabetes. The Cycloset formulation is uniquely different from existing formulations of bromocriptine. There is no therapeutic equivalent to Cycloset. Cycloset was formulated to provide a signal to brain that mimics the naturally occurring “insulin sensitive state.” The unique formulation is important to how the drug restores the “insulin sensitive state.”
Posted by Richard Scranton | Jul 01, 2009 at 5:37 pmYou better research the possibility of psychosis, fainting, low blood pressure, low heart rate, and pretty much screwed for life.
Posted by Neil | Jul 24, 2009 at 8:18 pm