Posted on 06/11/2005 9:27:00 PM PDT by FairOpinion
An experimental diabetes drug can control blood sugar without causing weight gain or swelling, according to a small mid-stage clinical trial presented on Friday.
The pill, called metaglidasen, is designed to regulate the genes needed to improve the body's response to insulin without activating those responsible for weight gain and fluid retention, according to its developer Metabolex Inc.
Existing insulin sensitizers commonly used to treat type 2 diabetes, including GlaxoSmithKline Plc's Avandia and Takeda Pharmaceutical Co.'s Actos, can cause weight gain and edema, which may lead to or worsen heart failure.
"Metaglidasen seems to work as well as these drugs without the safety issues," said Metabolex chief executive Harold Van Wart.
The drug was tested in a phase II trial of 217 patients with type 2, also known as adult-onset, diabetes who were also getting insulin injections. They were given either 200 mg or 400 mg of metaglidasen or a placebo once a day for 12 weeks.
The trial, presented at a San Diego meeting of the American Diabetes Association, showed that both doses of the drug reduced a measure of glucose control called A1C by 1 percentage point, compared with 0.3 of a point for the placebo group.
Metaglidasen also lowered fasting blood glucose levels by statistically significant margins.
Edema, which occurs in about 15 percent of patients with type 2 diabetes who are on insulin, was seen in 11 percent of the lower-dose metaglidasen patients, 5.8 percent for the higher dose and 16.2 percent for the group on insulin only.
Patients on the drug gained 0.5 kilograms on average, compared with 0.8 kg for the insulin-only group.
There were no cases of heart failure, Van Wart said.
The company also said both doses of metaglidasen had no significant effect on liver and muscle enzymes, kidney function or blood cell formation.
More than 18 million Americans have diabetes, in which the body does not produce enough insulin or cells ignore the insulin, which the body needs to convert food into energy. The condition can lead to debilitating or fatal complications such as heart disease, blindness, kidney disease, and amputations.
Several other companies are working to develop next-generation diabetes drugs.
Results from studies of muraglitazar, which is being developed by Bristol-Myers and Merck & Co. Inc., as well as AstraZeneca Plc's Galida are also slated for presentation in San Diego.
Both are designed to work like Actos and Avandia in controlling blood sugar -- with similar side effects -- while also lowering blood fats, offering the potential to reduce cardiovascular disease in people with type 2 diabetes.
The phase 2 study of metaglidasen showed unchanged lipid levels, except for the 400 mg dose which lowered triglyceride levels by 15 percent.
Metabolex is now testing a higher 600 mg dose of the drug in a second phase 2 trial and expects to launch a phase 3 study -- the final level needed for regulatory review of a drug -- in the second quarter of next year, Van Wart said.
Meanwhile, the Hayward, California-based company is looking to find a pharmaceutical partner to develop the drug, he said.
PING
An experimental diabetes drug can control blood sugar without causing weight gain or swelling, according to a small mid-stage clinical trial presented on Friday.
The company also said both doses of metaglidasen had no significant effect on liver and muscle enzymes, kidney function or blood cell formation."
That's pretty good.
bttt
I welcome any and all advancements in diabetes treatment because people on both sides of my family have diabetes and I'll probably have it eventually.
Sorry to hear about your husband getting diabetes. My grandpa was diagnosed with it in the past year or so. Is type II the one where you're insulin dependant? I keep getting the two types confused.
I would suggest you do a lot of research --- there are a lot of medications out there, but most also have side effects. If he can possibly control it by diet and exercise, that's always the best, but if he needs to take meds, you want to learn about all the possible ones.
Some people do very well on the "first line of defense" types, such as glucophage (metformin), others need more.
It is very important to treat it -- some dire things can happen if you don't, but as I said, read up and discuss various medications with your doctor, for best results and minimum side effects.
Type 1 is the one that people get young and are insulin dependent, because their pancreas doesn't produce insuling.
Type 2 is what people get later in life, but depending on the progression of that one, people can live just fine, just controlling it with life style modification, sometimes medications, or sometimes they need to take insulin also.
If you CAREFULLY watch your diet/weight, and exercise regularly, you can successfully stave off diabetes, even if you are genetically predisposed to the disease. This is difficult and tedious work at first, but your options for controlling your diet today are much more varied than they were 20 years ago. If you are concerned that you might be developing insulin resistance/rejection, get your blood tested at your doctor soon. Diabetes is nothing to be trifled with. It IS a definite KILLER if left untreated. Good luck!
My dad has been able to control his type 2 diabetes via diet and exercise...it really hasn't been difficult for him at all, so I strongly recommend that people try that before drugs.
Get him off all carbs immediately, including milk, potatoes, breads, pasta, rice, fruits, or nuts, and onto meat, fish, eggs, and fats. This is what is known as the induction phase of the Atkins diet. Get a keto test kit from a pharmacy to determine when he reaches full ketosis. At that point there is no need for medication (do not confuse this with 'cured'). The medications usually prescribed are as dangerous as high blood sugar is, but in different ways.
After ketosis is established, the problem can be attacked nutritionally. Minerals such as chromium, vanadium, potassium, and molybdenum need to be added to his diet, along with elagic acid (green tea is one carb-free source of elagitannins) and niacin. Try to find a physician that specializes in natural, and herbal therapy, that can monitor his condition. Most physicians know absolutely nothing about human nutrition.
You might want to re-think the Atkins/ketosis suggestion. If a diabetic has persistent episodes of hyperglycemia (high blood glucose, particularly in excess of 240 mg/dL)
and they are spilling large amounts of ketones into the urine (>80mg/dL), this is a DANGEROUS and LIFE-THREATENING condition known as diabetic ketoacidosis (DKA) that requires immediate hospitalization (usually 2 days in the ICU). One in every fifty people who check in to a hospital with DKA does not leave alive. And while DKA almost exclusively occurs in patients with Type I Diabetes, people with Type II can come down with it as well. I am speaking from personal experience.
I was diagnosed 1.5 years ago. If he is insulin resistant, diet and exercise can bring blood sugar to normal levels in a lot of people. No telling how long the release and adoption of the new drug will take.
Be careful. I took a nutrition class that dealt with Atkins. DO NOT GO ON ANY FAD DIETS!! Atkins has not been around long enough and already some seriously bad side effects are known now. Talk to a dietician or specialist.
'DO NOT GO ON ANY FAD DIETS!!'
I agree. When I was hospitalized with my Diabetes, all my doctors said the same thing. The key is a BALANCED diet with sensible portions. Carbs are NOT the enemy. In fact, the American Diabetes Association has about the best program going and they reccommend a 2000 calorie/day diet consisting of about 60% carbs (the 'base' of the food pyramid).
My next door neighbor is a cardiology resident and recently went off of Atkins because of poor results and unwanted side effects.
Edema in endocrine and metabolic diseases
Recently the range of therapeutic options of glycemic controls has been extended with introduction of thiazolidinediones (TZDs). Weight gain and peripheral edema are recognized side effects of these drugs, particularly when used in combination with insulin. The potential risk of worsened heart failure should be taken into consideration when TZDs are used in patients with diabetes and heart diseases.
The A1C referred to in the article is more properly called hemoglobin A1c, aka HbA1c, and it's used as a surrogate marker of blood glucose control over the past 90 days, IIRC.
I was diagnosed 4 months ago and had been expecting it for years just like you are.
This article is the first time I heard that Actos causes weight gain. That sure explains the rapid 10 pounds. GRRRRR.
Ask the doctor for a referral to a Certified Diabetes Educator, and a Registered Dietitian - preferably an RD that works with the CDE, or is a CDE themselves - and go with your husband to the appointments. Also - check out some of the on-line support groups' message boards - WebMD has a good one, and about.com has one as well. Start reading up on low-carb dieting, and the glycemic index - which is a way to further define what are 'good carbs' vs other carbs. And don't do the full blown Atkins thing - the reason for that is posted above - the DKA post.
Get the book Reversing Diabetes by Julian Whitaker, M.D. By following it, I was able to reverse my type 2 diabetes. My fasting blood glucose has been averaging about 90. I can get it lower by exercising. I also got his book Reversing Hypertension. I was able to get off high blood pressure medicine that I took for about 15 years. I now have an average blood pressure in the morning of about 115/75.
I've been on Atkins diet for over 5 years and the phase you all are talking about is the induction period. Many people foolishly try "Atkins" without reading his book and stay on the induction part of the diet that is very strict (20 grams of carbs per day) which is why they have so many problems.
After the second week - you're supposed to re-introduce the carbs that are safe (complex). But many people wanting to lose as fast as possible, do not follow his instructions that he states in his book - and consequently - they run into major problems.
My foot specialist was the one who recommended the diet to me (a low-carb diet) because he said that he has seen many diabetics lose their feet because they ate typical diets of bread, pasta, potatoes, etc. He stated that these were as bad or worse than straight simple sugars because they stay in the system longer - and are therefore more damaging!
I have been able to lower my blood sugar through this low-carb diet, natural remedies, and excercise all these years. I am now determined to restore my health through Noni juice - and I have already seen amazing healing in my feet because of it in just a short while!
** By the way - Atkins - Was a diabetic which is why he developed the diet - to restore and control his health without insulin!
Sorry - I was thinking of Dr. Richard K. Bernstein who was diabetic and used a diet similar to Dr. Atkins. You can read about his diet here: http://www.diabetes-normalsugars.com/
"Get the book Reversing Diabetes by Julian Whitaker, M.D. By following it, I was able to reverse my type 2 diabetes. "
Thanks for the info.
I googled and found his website, but strangely, I couldn't find his book there.
http://www.drwhitaker.com/index.asp
But then I did more searching and found the book on Amazon.com
http://www.amazon.com/exec/obidos/tg/detail/-/0446676586/104-5045617-9112763?v=glance
Related article about one of the drugs mentioned in the article:
Duel-use diabetes pill unveiled
Muraglitazar would lower blood sugar and cut heart disease risk; Merck and Bristol battling back.
http://money.cnn.com/2005/06/12/news/fortune500/muraglitazar/
You're talking about people who are taking insulin.
Hype. The 'Atkins' diet has been around for close to 6000 years. It is the basic human diet. The only known 'side effect' is that doctors end up loosing big chunks of income as people get healthy. That's why they are screaming so loud. Tell me about dieticians. My mother was a dietician, and head of the food services program at a hospital. I grew up on this stuff.
If the conditions are right (very high blood glucose plus high ketones) DKA can occur in either type I or type II diabetics, usually at the initial onset and diagnosis of the disease, but may occur at any time thereafter if circumstances (high stress, illness) trigger the aforementioned indicators. The high glucose indicates either: a. the pancreas has shut down and is no longer producing insulin, b. the pancreas hasn't shut down and is still producing insulin, but the body's cells don't 'recognize' the insulin, c. the patient has missed an injection of insulin, or has been injected with either the wrong type or wrong amount of insulin, d. the patient has eaten a meal rich in sugar, e. a combination of a,c, and d OR b,c, and d (this is common among the very young and the very old). High ketones can occur when: a. the body starts to burn stored fat or muscle tissue, or b. the body starts to burn fat or muscle from a diet rich in fat and muscle (Atkins). High levels of ketones in the blood will cause the blood to become too acidic. This toxic condition becomes DKA which, if not treated immediately leads to coma which can lead to death.
There is no credible doctor or diabetic educator/nutritionist that will go on record and reccommend the Atkins diet for either Type I or Type II diabetics, regardless of insulin usage.
If no carbs are ingested, no insulin should be administered. It is insulin insensitivity that brings on the syndrome known as type II in most cases. In every case, insulin insensitivity is due to excessive carb intake over an extended period of time, coupled with a lack of necessary nutrients, i.e. the 'mediterranian' diet, which is a media creation that has been bough up by those who profit from illness.
Speaking from experience...exercise, exercise, exercise and diet. Get him active. Start slow but make it regular. That's the key. Activity. A low carb diet also has good benefits.
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