Research about meds
There are lots of snake oils, herbs, and other concoctions that outrageously claim to control blood glucose. Comments at this forum should pertain ONLY to drugs that are undergoing clinical trials in expectation of FDA approval. Comments about products that I deem dubious will be removed.
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Bill the diabetesdoc
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Not sure if this is what you were seeking, but an official set of slides are available as a PowerPoint slideshow at Download complete PPT.
I've reproduced the 2 press releases about this study at Results of PROactive.
Personally, rather than all the hype, I'd prefer to read a journal article about the science of the study, and the editorial comments (if any) in the same issue. I don't see any mention of where this study might end up being published, and that's a pity. (Comment this)
Regarding the publication, it was mentioned at the top of the webcast that results would be published shortly in The Lancet. (Comment this)
Houston--(Feb. 16, 2004)--Amylin, a hormone secreted by the same cells that produce insulin in the pancreas, prevents bone loss, said Baylor College of Medicine researchers and an international group of collaborators in a report in today's issue of the Journal of Cell Biology.
The finding may point the way toward treatments for osteoporosis, a disease of low bone mass that usually affects post-menopausal women but that is also observed in Type 1 diabetes patients, said Dr. Gèrard Karsenty, professor of molecular and human genetics at Baylor College of Medicine (BCM) in Houston and senior author.
"If osteoporosis in diabetes is associated with the absence of amylin, this finding has therapeutic implications," he said.
Amylin, a member of the calcitonin hormone family, inhibits bone loss or resorption. It is secreted by the pancreatic ß-cells at the same as insulin. Type 1 diabetics no longer produce insulin or amylin because their ß-cells no longer function. Mice who lack amylin have less bone mass than those who produce the hormone because they destroy bone more rapidly as it is seen in classical osteoporosis said Karsenty. Perhaps, he said, finding a way to replace amylin will enable physicians in the future to prevent osteoporosis in Type I diabetes and possibly in other forms of osteoporosis.
The finding extends understanding of the connection between metabolic hormones and bone mass, he said. Previously, Karsenty and his team had demonstrated that leptin, a hormone associated with weight control, affects bone formation through a brain relay.
Researchers from BCM, Beth Israel Deaconess Medical Center, Harvard Medical School, the University of Pittsburgh School of Medicine, the University of Melbourne in Australia, Hanson Institute, in South Australia and Lund University Hospital in Sweden participated in the research.
The work was supported by the National Institutes of Health, the March of Dimes, the Children's Nutrition Research Center, the National Space Biomedical Research Institute and the National Health and Medical Research Council of Australia. (Comment this)
(Comment this)Please read Dubious comments at this blog
Thanks. (Comment this)
The results of Phase 1 clinical trials with a small patient set (14?) were phenomenally positive as Betty reported above.
Application for a large Phase 2, 1 year study, has been made to the FDA. It is expected to be approved.
Pending Phase 2 results, Wall Street financial analysts do not expect FDA approval (even with phenomenal positive results) until late 2008 to early 2010.
So, Byetta LAR is still 3 to 4.5 years away from commercial distribution. (Comment this)
Re Byetta LAR: My hope is that they will be able to combine that last part of the Phase II trials with phase III and/or get Fast Track status on Phase III thereby speeding up the process.
My hunch is that the key issue will be dosing.
One thing going for fast track is this: Amylin, Lilly, and Alkermes are working together to develop a sustained release, subcutaneous injection of exenatide for the treatment of type 2 diabetes based on Alkermes' proprietary Medisorb ® injectable long-acting release drug delivery technology.
Medisorb is already FDA approved and is used in several other FDA approved drugs.
So here we have Byetta BID and Medisorb, both proven and FDA approved, which are combined to formulate Byetta LAR which proves to be twice as effective as the BID version and have half the side effects. This should provide powerful statistics and incentive for quick approval. But, then again, we are dealing with a new Acting Head of the FDA so we dont know whats up his sleeve. But rest assured that there will be incredible pressure for early approval.
I do know that the former head of the FDA, Dr. Mark McClellan, currently administrator of the Centers for Medicare and Medicaid Services, is a proponent of getting drugs on the market that are preventative in the long term rather than drugs that treat terminally ill patients. Diabetes is at the top of his list.
I hope to see Byetta LAR approved sooner rather than later. (Comment this)
Suzan in Monterey, California (Comment this)
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(Comment this)There are several topics which relate to blood sugar testing or you can ask a more specific question and I will try to answer it. (Comment this)
thanks. (Comment this)
It is my understanding that the Long acting byetta trials are going to proceed to Phase 3 with the existing patient group.
This is a site that lets you search for Clinical Trials.
http://www.clinicaltrials.com/trials/trials.asp?illness_id=107&State=ALL&image.x=11&image.y=16 don't know if the link will hold but it's my search all states and diabetes Type 2.
http://www.centerwatch.com/ another search site.
http://www.controlled-trials.com/
I can't seem to find any open trials by searching these three sites.
(Comment this)
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(Comment this)http://www.drugresearcher.com/news/ng.asp?n=64526-lilly-pipeline-financial
Inhaled insulin is Lilly''s lead project, which also includes an oral
DPP-IV inhibitor for type 2 diabetes currently in Phase 1;
naveglitazar, an oral PPAR alpha/gamma agonist, for type 2 diabetes
that has completed Phase 2 studies; and a long-acting release
formulation of Byetta for type 2 diabetes currently in Phase 2.
Angela in Iowa
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Angela in Iowa (Comment this)
I wonder when they might release the 1 a week shot
Angela in Iowa
http://www.businessweek.com/magazine/content/06_02/b3966092.htm
Graham already has her scientists working on an improved version of Byetta, which may have to be injected only once a week, as opposed to twice a day. And the drug may offer an additional benefit: In August the company announced that in an early clinical trial, patients taking the longer-acting drug lost an average of nine pounds.
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I looked up ''Merk Incretin'' and there are several web sites there that talk about Incretin enhancers, as opposed to incretin mimetics, which is what Byetta is, of courseThere is one drug that is mentioned that is already in tial.
Don''t know if we could be so lucky as to not have the same side effects or how long it will before it''s available
but...?? Drugs always seem to improve as time goes on.
I''m going back there now to read all about it! (Comment this)
Just read on Medscape that there is a drug called Rimonabant that is in phase 111 trials for PREVENTING T2.
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recognition of Byetta''s potential for diabetics everywhere. (Comment this)
I should have paid more attention to this meds forum. (Comment this)
Also, the sites offered to show injection patterns are both good. Thanks for those. (Comment this)
Agricultural Research Service scientists are seeking a patent on compounds extracted from cinnamon that make cells much more sensitive to insulin in test tube studies.
Nearly 6 percent of the U.S. population—15.7 million people—have diabetes, and one-third of them don't even know it. The large majority of diabetes cases are type 2—the kind that usually begins in midlife. It is characterized by the failure of body cells to recognize and respond to insulin as well as they once did. This leads to elevated blood sugar because insulin's job is to prompt cells to take in glucose.
Another 13.4 million people have elevated fasting blood sugar levels below the threshold indicating diabetes but are at high risk for developing the disease. Lack of exercise, being overweight, and genetic predisposition are often cited as contributing factors involved in the high incidence of diabetes in western countries.
Worldwide, this silent killer claims more than 100 million lives annually. It is the seventh leading cause of death in the United States. And for many people, drugs or other forms of treatment are unavailable.
The search for a natural way to keep blood sugar levels normal began more than a decade ago when ARS chemist Richard A. Anderson and co-workers at the Beltsville (Maryland) Human Nutrition Research Center assayed plants and spices used in folk medicine. They found that a few spices—especially cinnamon—made fat cells much more responsive to insulin, the hormone that regulates sugar metabolism and thus controls the level of glucose in the blood.
With help from Walter F. Schmidt in ARS's Nuclear Magnetic Resonance Laboratory at Beltsville, the researchers identified the compounds in cinnamon responsible for its activity. The patent application names Anderson, his co-workers C. Leigh Broadhurst and Marilyn M. Polansky, and Schmidt as the inventors.
Cinnamon is among the world's most frequently consumed spices and is relatively inexpensive. Anderson and colleagues found that its most active compound—methylhydroxy chalcone polymer (MHCP)—increased glucose metabolism roughly 20-fold in a test tube assay of fat cells.
The researchers tested 50 some plant extracts and found that none of them came close to MHCP's level of affecting glucose metabolism—a process in which cells convert glucose to energy. If in future research MHCP proves to do the same in people, it might provide a natural remedy against diabetes.
What's more, MHCP prevented the formation of damaging oxygen radicals in a blood platelet assay.
"That could be an important side benefit," notes Anderson. "Other studies have shown that antioxidant supplements can reduce or slow the progression of various complications of diabetes."
MHCP is the first chalcone, a type of polyphenol or flavonoid, reported in cinnamon. MHCP and other active compounds are water soluble and are not found in the spice oils sold as food additives.
Anderson pointed out that the water extract reduced blood pressure in hypertensive rats even before it increased insulin sensitivity. And compounds in a water extract are less likely to be toxic in large doses than those in an oil extract, he says.—By Judy McBride, Agricultural Research Service Information Staff.
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1000 mg per day. My doctor says he wants me to take NiaSpan, brand name drug. My druggest says they are very
similar. Doctor say not! I went on the internet seaching
last night. Found some references to say they are the same.
Found, some on the Niaspan makers news releases, indicating
generic causes liver damage Niaspan does not. Does anyone
know about this issue? Also I see there are approvals for
another maker to make generic Niaspan, does anyone know when? Cost of Name brand is very high! Thanks (Comment this)
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(Comment this)Being one of the people who has had severe nausea from byetta,and after six months having not moved up to the 10, I would probably be one of those, who would not be a candidate for the LAR.
I'm looking forward to the developemnt of the incretin enhancers. (Comment this)
Just looked up ginger and found that it is contraindicated for those who are on blood thinners or a particular cancer drug therapy.
Forgot to thank you, Betty, for your insight. (Comment this)
Offering millions of diabetics an alternative to being stuck with a needle, the U.S. Food and Drug Administration on Friday approved a first: inhaled insulin.
The FDA approved Exubera for both type 1 and type 2 diabetes, calling the new medication-delivery option a potential alternative for "many of the more than 5 million Americans who take insulin injections." It's the first new delivery mechanism for the treatment of adult patients with diabetes since the discovery of insulin in the 1920s.
Complete article link: http://www.chicagotribune.com/technology/chi-0601280286jan28,1,5400164.story?coll=chi-business-hed&ctrack=1&cset=true (Comment this)
Since mannitol is one ingredient in Byetta, and roughly half the side effects of mannitol are what about 60% of us
are experiencing in one form or another, I can't help but wonder if that is the main culprit for our symtoms.
Nausea is listed as the number one symptom and it is also what I had experienced with all sugar alcohols.. so I will continue to make that connection ( as I still continue
with nausea.) Amalyn and others are probably tired of
hearing this from me, but I wish they could find a substitute ingredient. BTW, I feel it has also increased my urine output( not surprising since mannitol evidently
is a diuretic as well,( good reason to watch our fluid intake.)
Maybe the amount is too small to be responsible for most of the side effects we are having, but then it would be very coincidental. (Comment this)
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(Comment this)Hi all,
What a find! Finally I discover others who do their homework! Since my world is about staying on top of the literature, you can count on my online presence. I'm sure you all know this, but Medline, Cinahl, various nursing databases, and other sources are fee-based but free through libraries. These all have a friendlier interface than PubMed, and there are usually more full text articles. My favorite is MDConsult, but it costs too much unless you can find it through your local or academic library. Thanks for your contributions. (Comment this)
Forbes Magazine:
http://www.forbes.com/2006/02/13/amylin-exenatide-0213markets10_print.html
Market Scan
Amylin's Exenatide LAR Pricing In Half Of Stock's Value
Peter Kang, 02.13.06, 3:20 PM ET
Merrill Lynch upgraded Amylin Pharmaceuticals to "neutral" from "sell," citing more reasonable share prices, but said it continues to be wary of risks related to experimental drug exenatide LAR.
"We remain cautious on the stock as optimism over strong Byetta sales is offset by the company's uncertainty about the clinical trials that will be required by the FDA for seeking approval of exenatide LAR, the once weekly version of Byetta, for type 2 diabetes," wrote Merrill Lynch analyst Thomas McGahren.
The analyst estimates about half of Amylin's stock price is attributed to the future success of exenatide LAR, in development with Eli Lilly (nyse: LLY - news - people ), and trades on the assumption the drug will hit the market by 2009.
"Any delays in the clinical development and launch would adversely impact the stock," he said.
Amylin (nasdaq: AMLN - news - people ) will provide an update on whether the U.S. Food and Drug Administration will allow an open label clinical trial of exenatide LAR, set to begin in the second quarter, to serve as the "line extension" registration trial.
"If not, then the clinical path for exenatide LAR will take longer, thus hurting valuation."
McGahren values Amylin stock at approximately $36 per share, assuming a 65% probability exenatide LAR launches in the April 2009 time frame with peak sales of $2 billion.
Byetta is co-marketed by Eli Lilly and was approved last April.
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I agree that the information we find is often confusing becauuse one person will say one thing and another will say the opposite. It is really easy to find one with which you would prefer to agree and stop the reaearch right there. In depth research means that you will be like a criminal investigator and look for a preponderance of evidence before approaching a valid conclusion.And many doctors want more evidence before they prescribe. We must understand that there are lots who believe that a super-conservative approach works best. Others say that there is enough evidence available so let's work with it. It's up to the patient to listen to them, collect their own evidence and make an informed decision believed to be for the best outcome.
Speaking of evidence, I have not yet come across anything to support blaming Byetta for increased susceptibility to infection. Does anyone have a reference I could look at?
Not everyone gets sleepy with B vitamins. And your still-vivid dreams seem to indicate that you have not yet increased your B6 and are taking a multi for your Bs. And I also noticed a decrease in cramps when I took my calcium at night. But, given my preceding statements, don't take MY word for it!!!LOL
Leah
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How much B6 do you think I should be increased to at night? (Comment this)
I can only tell you what I take and then refer you to a site which will give you more info.
I take 100 mg. every day. If I get bad dreams, that's the signal and I double it for 4-7 days. 100 mg. is the upper level of tolerance listed by the NIH. It is water soluble.I take this much because I am older and on the Byetta (because of lower food intake). You will see why when you read the longer version.
Put Medline Plus into your search. When you find it, enter Vitamin B6 in their search window. This is the NIH site and will give you a lot of great researched! material in an easy-to-read form.
Best,
Leah
(Comment this)
Thanks Leah, that is a very helpful website! (Comment this)
Januvia will likely hit the market in October
http://www.redherring.com/Article.aspx?a=15746&hed=Merck+Gets+Ahead+in+Diabetes§or=Industries&subsector=Biosciences#
The pharma giant overtakes Novartis in a new class of diabetes treatments.
February 15, 2006
U.S. drug maker Merck took a lead over Switzerland’s Novartis on Wednesday in the race to get a new class of diabetes treatments approved by U.S. regulators and on the market.
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The Whitehouse Station, New Jersey-based company said the U.S. Food and Drug Administration (FDA) had accepted its experimental drug Januvia for review, a move that analysts did not expect for up to another year.
It means that if approved, Januvia will likely hit the market in October, making it the first in a new and important class of type II diabetes pills called DPP-4 inhibitors.
“We had originally believed Novartis had the lead program,” wrote SunTrust Robinson Humphrey analyst Robert Hazlett.
Mr. Hazlett said the firm’s sales estimates for Januvia now move ahead a year to $25 million in 2006, $400 million in 2007, $850 million in 2008, and $1.3 billion in 2009.
Novartis is also developing a DPP-4 drug called Galvus, which analysts expected the company to file for in the first quarter of this year.
DPP-4 inhibitors work by blocking the destruction of a hormone produced in the intestine. This hormone, called GLP-1, binds to the pancreatic beta cells which make and secrete insulin into the bloodstream, causing them to replicate.
Because the problem in type II diabetes is a slow and continuous decline in beta cells, DPP-4 inhibitors could actually work to improve patients’ health, rather than simply treat the symptoms of the disease.
It also means that DPP-4 inhibitors don’t cause hypoglycemia (dangerously low blood sugar levels), a common side effect of insulin treatments.
“Based on our clinical studies, we believe Januvia represents a new and different approach to the treatment of type II diabetes,” said Richard T. Clark, chief executive and president of Merck.
Competition Coming
However, Merck’s data from its trials of Januvia have not been revealed. In contrast, Novartis has told analysts that it plans to give the FDA a comprehensive set of results from trials of both once-a-day and twice-a-day tablets. This data will include how the drug fared both on its own and in combination with drugs metformin, sulfonylurea, and TZDs (anti-diabetes drugs called thiazolidinediones)—and the hormone, insulin.
Both companies are expected to discuss their data in June at the meeting of the American Diabetes Association.
Type II diabetes accounts for 90 to 95 percent of all diabetes cases. It not only affects the cells in the pancreas, but also slowly destroys the whole body, leading to lower-limb amputations, blindness, and kidney disease. It also doubles the risk of Alzheimer’s disease, and increases the risk of cardiovascular disease and stroke by three to five times.
The life span of diabetes patients is on average 15 years shorter than those without the disease.
“Diabetes research represents 3 percent of the overall budget of the U.S. National Institutes of Health and has decreased more than 30 percent since 1981, whereas the death rate owing to diabetes has increased by 30 percent,” reads a 2004 paper in the European Molecular Biology Organization.
The first detectable sign of type II diabetes is insulin resistance in muscle tissue. This can go on for years before apparent symptoms develop, causing the pancreas’ beta cells to pump out more insulin to lower the levels of glucose in the blood. The overuse eventually kills them off.
Treating the Problem
Several other companies are developing treatments for type II diabetes based on the action of the hormone GLP-1.
Amylin Pharmaceuticals already has a GLP-1-like drug called Byetta on the market, which is derived from the saliva of a desert reptile known as a Gila monster (see ‘Gila Monster’ Drug Approved and Amylin Rises on Diabetes News).
But the new experimental drugs are not without their problems. ConjuChem, based in Montreal, has had to scrap tests of one GLP-1-based experimental drug after it failed toxicity tests in animal trials.
The company is starting an early-stage clinical trial at the end of March in an experimental compound called TC-DAC:Exendin-4.
“It’s Amylin’s Byetta but what we are doing is adding our DAC technology to make a dose last a week or more in human beings,” ConjuChem’s CFO Lennie Ryer told RedHerring.com.
ConjuChem’s DAC technology bonds drugs to the most common protein in blood so that it increases the amount of time they spend circulating in the body.
© 1993-2006 Red Herring, Inc. All rights reserved.
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