John Buse, MD, PhD, from the University of North Carolina, provides more detail regarding the recently published clinical trial results. See the article in the January 18, 2011 issue of Annals of Internal Medicine. Use of Twice-Daily Exenatide in Basal Insulin–Treated Patients With Type 2 Diabetes: A Randomized, Controlled Trial.
Hi this is john views from the university of north carolina and i’ve been asked by eye doc to comment on a poster presentation that i made at the american diabetes association meeting just a couple of weeks ago the study is called gw ceo doesn’t stand for anything it’s just the letters that were assigned to it it involved using eggs init id in the current twice a
Day formulation as compared to placebo in patients that were treated at baseline with glargine insulin in combination with metformin and/or pioglitazone what we did in the study is in patients who had an a1c of more than eight percent they stayed on their same dose of glargine and the oral agents if their a1c was less than eight percent at the baseline visit they had
Their dose of glargine reduced by twenty percent and then they were administered exenatide five micrograms twice a day or placebo twice a day for four weeks as is the usual with eggs in a tight and then the dose was increased of exenatide or placebo to ten micrograms twice a day now at that point in time if the fasting glucose was elevated using the so-called treat
To target algorithm which was developed by matt riddle glargine doses were increased on at least a weekly basis to try and get the fasting glucose down at the end of twenty six weeks what we saw was the fasting glucose in the placebo-treated patients and the exempt id treated patients were identical suggesting that we had titrated the glargine equally effectively in
Both the exam atty treated patients and the placebo-treated patients and the dose of insulin in the exenatide treated patients was was a bit lower the hemoglobin a1c effect was extremely robust with the combination of titrated glargine to get the fasting glucose down and eggs and tide twice a day the end result hemoglobin a1c on average was six point seven percent
There was about a point seven percent difference in a1c in the placebo-treated patients with an end result of about 7.3 percent so a statistically significant greater reduction in hemoglobin a1c with the combination of exenatide and titrated gloire gene but most interesting was that despite the fact that the a1c was substantially lower with egg zenit id as compared
To placebo there really was no increase risk of hypoglycemia and specifically with regards to severe hypoglycemia the only episode occurred in a patient that was treated with placebo and also as you might expect there was moderate weight loss in the exhibit i’d treated patients as opposed to weight gain in the patients treated with placebo so we did this study for
Two reasons one was because i think it’s pretty clear that long-acting insulin is the most effective fasting glucose treatment that we have and that egg zenit id is the most effective postprandial treatment that we have so the combination really was potentially exciting that we would be able to control fasting and postprandial glucose very effectively and i think
We basically demonstrated that with the you know the very nice reduction in a1c down to six point seven percent but the other concern was safety that by using these two powerful therapies would we run into all kinds of problems with with hypoglycemia we were very relieved to see that there really was no increase in hypoglycemia at all and the additional benefit
Of weight loss so we didn’t do a formal comparison to the alternative in the uncontrolled patient on oral agents plus glargine which would be the addition of rapid acting insulin but we do know in general that adding rapid acting insulin to glargine if anything would would increase weight gain i certainly wouldn’t reduce way cane and has been well demonstrated to
Increase hypoglycemia so we hope in the future to do that kind of head-to-head study of multiple daily injections of insulin versus exenatide plus glargine but for now we know that that that combination looks to be very effective anyone see lowering without any new or emerging issues with regards to safety so for eye doc this is john buse thank you very much for listening
Transcribed from video
GLP-1 Agonists in Basal Insulin-Treated Type 2 Diabetes Patients By iDOCpodcasts
