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Posts with tag placebo

Novo may have a better treatment for Type 2 diabetes

In light of Novo's Meet the Face of Change campaign, I figured I'd address an idea worthy of mention coming out of the Novo product pipeline. This treatment is for Type 2 diabetics but it is not insulin - it's called liraglutide. Liraglutide is a once-daily human analog of the natural hormone Glucagon-Like Peptide-1 (GLP-1). It causes neither excessive hypoglycemia nor weight gain.

Liraglutide works by stimulating the release of insulin only when glucose levels become too high. Unlike many other diabetes drugs - liraglutide also leads to weight loss instead of weight gain. Now we're getting somewhere, Novo!! Patients with Type 2 diabetes treated with liraglutide had a greater reduction in average blood sugar than those patients treated with placebo or insulin glargine (Lantus). As expected, the combination of a GLP-1 analog with a sulfonylurea caused some of the patients to experience hypoglycemia. Okay, point taken. So why impose a glucose lowering drug while mitigating the problem causing elevated sugar in the first place? One drug at a time, folks.

So this is a step in the right direction and I like where it is going. Treating Type 2 diabetes with insulin is counter-intuitive. Looking at another hormone that might interfere with the use of insulin might be the culprit. So here lies a very good idea and I like it. Gold star, Novo! Now when can we meet the face of liraglutide?

Accidental Diabetes Drug

Much like a roadblock, but with a fortuitous outcome -- an experimental heart drug didn't achieve the primary goal of a late-stage trial but it did dramatically reduce the risk patients would develop diabetes.

The anti-oxidant, anti-inflammatory drug, the first of its kind, reduced the risk of developing diabetes by 64% and demonstrated a small but statistically significant reduction in blood sugar after 12 months. The study included data from 6,144-patients. The company believes this finding to be a serendipitous outcome, despite the initial shortcomings of the trial objective. They need to confirm it in a large clinical trial. The impressive diabetes results may come as a surprise to investors who have abandoned AtheroGenics or who have been betting the drug will fail.

Heart patients in the study received either 300 milligrams of the drug or a placebo on top of a host of standard-of-care medicines they were already taking, such as aspirin, cholesterol-lowering statins, blood thinners and/or diabetes medicines.

The drug had an undesirable impact on blood fats, raising bad LDL cholesterol by about 12% and lowering good HDL cholesterol by roughly the same amount. There were also some potentially troubling safety signals with a trend toward more heart failure in those taking the drug. In spite of the undesirable affects on blood lipids, the drug has a profound effect on diabetes. Further research will be conducted on the efficacy of this drug in reducing the risk of developing diabetes.

No Benefit Found for Post-Stroke Tight Glucose Control

British researchers have found that tight glucose control during hospitalization for a stroke may not improve survival.

The study involved 933 patients enrolled within 24 hours of a stroke who had glucose in the range of 6.0 to 17 mmol/l. Participants received saline solution or continuous glucose, potassium, insulin infusions to reduce their blood glucose. Patients were monitored every two hours with glucose adjusted if needed every eight hours. The researchers found that both treatment and placebo groups had improvement in glucose levels. The treatment group had an overall mean 0.57 mmol/l reduction in glucose over 24 hours while glucose levels also fell spontaneously with simple saline hydration. There was also no difference in the secondary outcome of disability. There was a significant reduction in systolic blood pressure in the treatment group. A researcher noted, "In the majority of patients, treatment with a simple saline infusion will correct mild to moderate hyperglycemia."

The saline and glucose relationship is similar to the way the noninvasive glucose monitors measure blood sugar (aka Glucowatch)., This relationship between sodium and glucose in the blood moves inverse. When your sugar levels are elevated, your sodium is down. When you force sodium into your blood, your sugar is suppressed. Doctors must proceed with caution in light of this study. When it comes to aggressively lowering glucose, especially after a trauma, it could be more harmful than helpful.

Zinc Does Not Prevent Diabetes

Despite claims by zinc supplement manufacturers that the pills can help prevent type 2 diabetes, clinical trials do not support this hypothesis.

Laboratory research suggests that zinc helps promote the production and action of insulin. A four-week study of 56 obese women found that zinc did not have an effect on factors associated with the development of diabetes. This study was an example of one trial that treated 56 people with either zinc or a placebo for four weeks and found no effect. This single trial is too small and too short to tell us anything about the effectiveness of zinc in preventing the development of type 2 diabetes.

Research does support that zinc plays a key role in the regulation of insulin production and glucose utilization. Diabetics have shown a zinc deficiency, which impairs their ability to use glucose. However this fact does not confirm zinc as a supplement to prevent the development of diabetes. I apologize it's a nonevent insofar as news. But look at it this way – it's one trial. Nobody says you have to cross it off your list because 56 obese women didn't see a change in their risk factors for developing diabetes. One study is not gospel.

Chromium Improves Glycemic Control

Chromium picolinate is one of the most widely debated supplements in diabetes health. A study has shown that it improves glycemic control in patients with type 2 diabetes not adequately controlled while taking sulfonylurea, a drug that increases insulin release from the beta cells in the pancreas.

A 40-week study was designed to examine the effect of adding daily chromium picolinate supplementation to an antidiabetic medication, sulfonylurea. A commonly prescribed treatment for type 2 diabetes was given to 29 subjects for 24 weeks, in conjunction with either chromium picolinate or a placebo. Blood sugar levels of study participants taking chromium picolinate dropped significantly compared to the placebo group. In addition, insulin sensitivity for participants taking the chromium picolinate was increased when compared to those in the placebo group. Study participants taking chromium picolinate also experienced significantly lower abdominal body fat accumulation than the placebo group, and experienced less overall weight gain.

This study demonstrates that chromium picolinate supplementation for type 2 diabetes who are taking sulfonylurea agents significantly improves insulin sensitivity and glucose control. In addition, chromium picolinate was shown to reduce weight gain and fat accumulation compared with the placebo group. The results of this study were first published in August 2006 - but knowing about chromium picolinate today leaves you with ample time to adjust for greater insulin sensitivity and less fattening days to come!

Xenical may help deter onset of Diabetes

The journal Diabetes Care reports obese adults who lost a substantial amount of weight through lifestyle modification and dieting regained less weight when they took the diet drug Xenical, This approach was also associated with a reduced occurrence of type 2 diabetes.

Xenical burns fat while you are eating by inhibiting the absorption of dietary fat from your food. Studies have shown that the drug promotes more weight loss than lifestyle modification alone. The study examined the effectst of Xenical in preventing weight regain in 383 obese adults who had lost an average of 31.7 pounds (14.4 kg) on an 8-week protein-rich, very-low-energy diet. The 309 participants who lost 5% or more of their bodyweight then received lifestyle counseling for 3 years while taking either Xenical or a placebo pill daily. Both groups regained some weight. Xenical patients regained an average of 10 pounds, while placebo patients put back an average of 15 pounds.

Most importantly, during the 3-year study period only 8 of 153 in the Xenical group developed type 2 diabetes compared with 17 of 156 in the placebo group. That's remarkable. Twice as many people were diagnosed with type 2 diabetes, in addition to regaining one and a half times the weight. As an aside (and not to be a whistleblower) but one of the warnings on the label says the drug should not be taken for more than 2 years. Just an FYI.

A diamond in the rough to cure diabetes

Diamyd Medical's flagship drug, Diamyd, is showing promising results in reducing the need of insulin injections and preventing the destruction of beta cells.

Diamyd has demonstrated significant efficacy in preserving insulin production in 70 children and adolescents with type 1 diabetes. No serious adverse events associated with the therapy were observed. The results from the Diamyd study demonstrate that the group of 35 recently diagnosed type 1 diabetes patients that received Diamyd produced approximately twice as much meal stimulated insulin (as measured by C-peptide) 15 months after the first treatment as compared to the placebo group. Preserving insulin-production is crucial for delaying the complications associated with long-term diabetes which cost billions of dollars to treat. Furthermore, it may allow for regeneration of beta cells in a non-autoimmune environment, thus setting the stage for a cure of the disease.

"We look forward to opening the dialog with the FDA regarding the potential initiation of our clinical program for Diamyd in the US" says Anders Essen-Möller, CEO of Diamyd Medical. "We obviously cannot predict the outcome of any meeting with the regulatory authorities, but we hope we will gain some valuable guidance towards structuring a suitable US clinical program for the continued development of Diamyd as a therapy for type 1 diabetes." Anders-you let me know if the regulatory authorities give you any funny business. I'll see what the diabetic community has to say about it. The buck stops here!

Diabetes Drug Helps Prevent Fatty Liver Complications

According to a new study published in the New England Journalism of Medicine, the diabetes drug Actos may help prevent serious complications from nonalcoholic fatty liver disease. The disorder is primarily caused by being overweight. Insulin resistance, diabetes and high levels of cholesterol all contribute to the development of nonalcoholic fatty liver disease and its complications.

The study included candidates with either insulin resistance or type 2 diabetes. About half of the group took 45 milligrams of pioglitazone (brand name Actos, manufactured by Takeda Pharmaceuticals) daily for six months, while the other half took a placebo. Both groups were asked to maintain a lower calorie diet. The group taking pioglitazone saw a decrease in their levels of abnormal liver enzymes and a 54 percent reduction in liver fat, compared to the placebo group. Insulin sensitivity in the liver improved by 48 percent in the pioglitazone group, as compared to only 14 percent in the placebo group.

Current treatment for nonalcoholic fatty liver disease is aimed at lifestyle changes, such as losing weight and exercising regularly. Pioglitazone offers a resolution to improve the metabolism of blood glucose, and decreases cholesterol. Researchers were especially excited by the findings of this study because there is now a pharmacological option that might help prevent end-stage liver disease.

Praise be to Cinnamon

A study from U.S. researchers has found that daily supplementation with a cinnamon extract may boost the body's antioxidants, which can lessen the complications associated with metabolic syndrome. Metabolic syndrome is characterized by obesity -- especially around the midsection -- hypertension and reduced metabolism of both glucose and insulin. The syndrome is associated with an increased risk in the development of type 2 diabetes and cardiovascular disease.

The study recruited 24 participants with impaired fasting glucose levels for a double-blind, placebo-controlled study. The patients were split into two randomly assigned groups: the first received a daily dose of 500 mg of cinnamon extract and the second received a placebo. After 12 weeks, the researchers found that in the cinnamon extract group, antioxidant levels were significantly increased compared to the placebo group. Plasma levels of a reactive compound related to oxidative stress were also lower in the cinnamon group, but remained unchanged in the placebo patients. Oxidative stress is responsible for many of the microvascular changed responsible for diabetes complications: blindness, numbness, kidney damage, and amputations.

Beyond the resounding proof of cinnamon being helpful in diabetes management, other health-related benefits include: improved digestion, toning of tissues, relief from congestion, muscle and joint pain relief, relief from menstrual cramping, thinning of the blood and better circulation, relief from arthritis pain, prevention of urinary tract infections, prevention of tooth decay, and killing of harmful bacteria. I think a sprinkle of cinnamon is worth the pound of prevention this little spice is punching. How much is 500 mg of cinnamon anyway?

Regimen reduces diabetes risk...if you take your meds as prescribed

A new study has found evidence that a regimen of preventive medications is effective in reducing diabetes risk. But here's a little secret: you have to stick with the program long-term. Yes, one of the problems that health care providers face, apparently, is the fact that many people prescribed these meds don't continue to take them regularly.

The medication that is often prescribed to at-risk patients is metformin. The Diabetes Prevention Program carried out a large study (involving 2,155 subjects) that evaluated the effectiveness of lifestyle changes - in the form of healthy diet and increased exercise - compared with metformin prescriptions. The idea was simple: to show which tactic is most helpful in delaying or preventing the onset of Type 2 diabetes in patients identified as high-risk. Turns out metformin works quite well, actually. The patients taking it showed a 38.2 percent reduced risk for diabetes compared with others in the group who were put on a placebo. As mentioned above, though, a problem is getting people to take the drug routinely. The researchers say around twenty-two percent of patients reported forgetting to take their pills. Others blamed adverse effects and "disruption of routine."

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