Posted on 07/02/2010 2:29:52 PM PDT by neverdem
Orexigen® Therapeutics, Inc. (Nasdaq: OREX) today announced data from the CORDiabetes trial for Contrave® (naltrexone sustained release (SR)/bupropion SR) showing that after 56 weeks of treatment, overweight or obese patients with type 2 diabetes lost significantly more weight and achieved greater improvement in glycemic control than those treated with placebo.
Over twice as many patients lost at least 5% of their body weight on Contrave versus placebo on an intent-to-treat (ITT) basis (44.5% vs. 18.9% respectively), according to the data presented today by Dr. Priscilla Hollander, M.D., Baylor Medical Center, at an oral session of the 70th Scientific Sessions of the American Diabetes Association. Importantly, Contrave-treated patients experienced clinically significant reductions in A1C. Average baseline A1C, the standard test for monitoring glycemic control, of approximately 8.0% was reduced by 0.6% for Contrave compared to 0.1% for placebo. This translated to over 44% of Contrave patients reaching the American Diabetes Association (ADA) treatment target for A1C of less than 7%. In comparison, 26% of placebo patients reached the same threshold (p<0.001).
"It is well understood that weight loss is beneficial for glycemic control and slows disease progression in patients with type 2 diabetes," said Dr. Hollander, a lead investigator on COR-Diabetes. "The COR-Diabetes study demonstrated the potential utility of Contrave for obese patients with diabetes, where weight loss and weight management, coupled with a clinically meaningful improvement in glycemic control, improves overall health."
The impact on A1C was shown to be most profound in Contrave patients who started the trial with poor glycemic control. In fact, those patients who had a starting A1C greater than 8% exhibited an A1C improvement of -1.1%, compared with -0.5% in patients on placebo (p<0.01). In addition, significantly fewer patients taking Contrave were treated with diabetes rescue medication (22.3%) compared to placebo patients (35.2%), (p<0.01).
According to the ADA, diabetes affects 24 million Americans, a number that is projected to grow to 44 million over the next 25 years, driven largely by rising rates of obesity. The cost of treating the disease is expected to triple over the same time period. Obesity is the single greatest risk factor for type 2 diabetes; approximately 85% of patients with type 2 diabetes are overweight or obese.
Improvements in Markers of Cardiometabolic Risk
Patients treated with Contrave also showed improvements in a number of other measures of cardiometabolic risk, as shown in the table below:
The most frequently observed treatment-emergent adverse events in COR-Diabetes were nausea, vomiting, constipation and dizziness. Nausea was the leading adverse event resulting in discontinuation.
"The results of the COR-Diabetes study demonstrate the important role of weight loss and weight management as a cornerstone in the treatment of obese patients with type 2 diabetes," commented Dr. Dennis Kim, Orexigen's Senior Vice President of Medical Affairs.
Study Design
COR-Diabetes was a 56-week placebo-controlled, double-blind randomized trial of 505 overweight or obese patients with type 2 diabetes, whose A1C levels were between 7% and 10%>the United States participated in the study.
SOURCE Orexigen Therapeutics, Inc.
Naltrexone (hydrochloride), an opioid antagonist, is a synthetic congener of oxymorphone with no opioid agonist properties. It's those agonists that people abuse.
Bupropion is an antidepressant medication.
Orexigen Diabetes Drug Helps Diabetes Patients Lose Weight, Cut Glucose
It’s always encouraging to read posts like this. Thanks for posting.
I wonder what Contrave will cost? $3+ per pill I suspect.
Has anybody seen side by side comparisons between Contrave and Metformin or Glipizide?
Naltrexone and bupropion are generics. Any premium is for the sustained release formulation for once daily dosing.
Has anybody seen side by side comparisons between Contrave and Metformin or Glipizide?
No, it's too new.
It’s Welbutrin. And its also used to treat smoking. I guess they are trying to solve overeating with an antidepressant. Either that or they are suggesting that diabetes and Atypical depression are linked.
Type I diabetes also has its genetic component ~ the Finns, for example, have the world's highest incidence of Type I and it is believed that there is a selective advantage for it in what turns out to be the Earth's most rigorous climate for the largest number of people. Some folks develop Type I, and some develop something short of that, but it's not Type II ~ just a shortage of insulin ~ readily handled with supplemental insulin input.
Going beyond that, the genetic incidence of Type II, is, in general, about 5%. With 300 million people the US can have 15 million diabetics. Half of them have been diagnosed already. The other half simply haven't developed it yet.
To have 44 million diabetics in the US we'd need a population of about 900 million people!
It's a press release, IMHO.
I am in the last thirty days of a drug trial for the drug Code names ASP 1941. At this point I don’t know if I am taking one of the four provided dosages or metformin or a placebo.
In about 12 weeks or so, my A1c is down slightly from 7.1 to 6.8 and morning fasting glucose is stabilizing around 135 or so. I have lost around 6% of my body weight and according to my WII, have effectively lowered my BMI from obese to over weight.
I suffered no adverse side effects normal to ASP 1941 or Metformin. My only known effect is days when I am totally wiped out. I attributed this to lower than normal glusose level but leaned that it may result from low blood pressure. The reason for lowered blood pressure was not yet determined.
Any way, it is interesting to see all this up close. My file is now at least 200 pages in a looseleaf binder.
The next 30 days will be a continuation of the monitoring but no medication.
Here we go again... people lost 5% of their weight and reduced A1c by .(something)%. Big deal!
Odd that everyone is choosing to ignore the recent studies that show tight control of BG (less than a 7 A1c) is actually harmful.
All these drugs do is lower the numbers. Lowering the numbers is not treating the disease. No study has shown that lowering the numbers reduces the serious complications from diabetes in the long term. People are being lulled into a false sense of security. About the only thing that can really help type 2 diabetes is lots of exercise and cutting down on carbs... and this is a maybe. There is even some evidence that the weight gain associated with diabetes may be the body’s way of coping with it and could be helpful. http://www.obesitypanacea.com/2009/11/grow-more-fat-and-improve-metabolic.html
I hate to say it, but type 2 diabetes may act like a slow-growing cancer, and medical science has not yet produced any truly effective treatments for it.
Ask them the mechanism of action for ASP 1941 before you're finally out the door, please?
My only known effect is days when I am totally wiped out. I attributed this to lower than normal glusose level but leaned that it may result from low blood pressure. The reason for lowered blood pressure was not yet determined.
Maybe you have metabolic syndrome, aka syndrome X, which includes high blood pressure. By losing weight and treating the type 2 diabetes a drop in blood pressure might be a physiologic response. We're you taking drugs for high blood pressure or a large prostate?
Thanks for the update.
Thank you for that info. Glad you’re improving.
how does naltraxone effect weight? or wellbutrin?
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