Oct 3 (Reuters) - An experimental once-a-week drug for type 2 diabetes being developed by Merck & Co proved effective in lowering blood sugar levels in a mid-stage clinical trial, according to data presented on Wednesday.
The pill, known as MK-3102, is from the same class of medicines as Merck's successful daily diabetes drug Januvia, known as DPP-4 inhibitors.
The 685-patient study tested MK-3102 at five doses - ranging from 0.25 milligram to 25 mg - against a placebo, with the primary goal being reduction in A1c, a common measure of blood sugar.
After 12 weeks of treatment with the Merck drug, A1c was reduced 0.71 percent at 25 mg, 0.67 percent at 10 mg, 0.49 percent at 3 mg, 0.5 percent with 1 mg, and 0.28 percent for the lowest 0.25 mg dose. The reductions compared with placebo for all doses were deemed to be statistically significant, according to Merck, which presented the data on Wednesday at the European Association for the Study of Diabetes (EASD) meeting in Berlin.
Based on the encouraging Phase II results, Merck said it is beginning larger Phase III trials of the drug -- typically the final stage of human testing before seeking regulatory approval. The company said it has chosen to advance only the 25 mg dose for a Phase III program that will test MK-3102 against, and in combination with, a variety of diabetes treatments.
The 0.71 reduction seen with the 25 mg dose in the study is similar to the glucose reduction attained by Januvia, known chemically as sitagliptin.
Januvia has been a bright spot for Merck. It and a related combination diabetes pill called Janumet saw sales jump to $1.47 billion in the second quarter, putting the franchise on track for nearly $6 billion in sales this year.
"We do anticipate the efficacy, safety and tolerability of this will be comparable to sitagliptin," Nancy Thornberry, Merck's head of diabetes and endocrinology, said in a telephone interview from Berlin.
"We have almost six years of marketed use with sitagliptin, and so the safety and tolerability of the class as a whole has been extremely well established, as has the efficacy profile," Thornberry said.
However, she stressed that MK-3102 was a new compound and not simply a new formulation of Januvia. As with all new diabetes treatments since GlaxoSmithKine's Avandia was linked to serious heart risks, Merck will be expected to demonstrate the heart safety of MK-3102 in its Phase III trials.
Patients in the Phase II study began the trial with an A1c level of about 8 percent. American Diabetes Association guidelines call for A1c levels of 7 percent or lower.
The drug was generally well tolerated with a safety profile similar to placebo, Merck said.
As with Januvia, the new drug is likely to work by itself or in combination with other diabetes treatments, including insulin, Merck said.
"We think this is going to be a very attractive choice for patients who have a high pill burden. Any attempt to simplify the regimen for those patients is helpful," Thornberry said.
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Despite cheese's less-than-healthy reputation, a recent study in the <a href="http://www.ajcn.org/content/96/2/382.abstract" target="_hplink"><em>American Journal of Clinical Nutrition</em></a> showed that <a href="http://www.huffingtonpost.com/2012/07/27/cheese-diabetes-type-2-risk-link-_n_1699374.html?utm_hp_ref=healthy-living" target="_hplink">cheese-eaters</a> actually have a 12 percent <em>lower</em> risk of the disease than their non cheese-eating counterparts. Plus, people who ate more cheese, fermented milk and yogurt in the study were also more likely to have a decreased diabetes risk than people who ate less of these foods, noted the researchers, who came from Oxford University and Imperial College London. The people who ate the most cheese in the study consumed more than 56 grams of it per day, while those who <a href="http://www.nhs.uk/news/2012/07July/Pages/Can-a-diet-of-cheese-beat-diabetes.aspx" target="_hplink">ate the least cheese</a> in the study had fewer than 11 grams a day, the UK's NHS Choices reported.
Researchers from the Louisiana State University Agricultural Center found that people who <a href="http://www.huffingtonpost.com/2012/04/15/-nuts-diabetes-heart-disease_n_1423911.html" target="_hplink">regularly eat tree nuts</a> (we're talking pistachios, walnuts, almonds and cashews) have a lower risk of Type 2 diabetes, as well as heart disease and metabolic syndrome. Those researchers found that nut consumption is linked with lower levels of an inflammation marker called C-reactive protein (which is associated with heart disease and other chronic conditions) and higher levels of the "good" kind of cholesterol. In addition, people who regularly ate the tree nuts had lower body mass indexes (BMI, a ratio of height to weight) than people who didn't regularly eat nuts, the <em>Journal of the American College of Nutrition</em> study said.
Take A Walk
Taking a few moments <a href="http://www.huffingtonpost.com/walking-diabetes-risk-steps_n_1637808.html" target="_hplink">for a walk each day</a> is enough to lower the risk of diabetes in high-risk people who don't regularly exercise, according to research in the journal <em>Diabetes Care</em>. University of Washington and University of Pittsburgh researchers found that people who walked the most in their study -- which included 1,826 people from Native American communities -- had a 29 percent lower risk of diabetes, compared with those who walked the least. But you didn't have to be a star walker in the study to reap the benefits -- the researchers found that 12 percent of people who took just 3,500 steps per day (there are about 2,000 steps in a mile) developed diabetes at the end of the study period, compared with 17 percent of people who <a href="http://in.reuters.com/article/2012/06/28/health-diabetes-idINL3E8HS5BR20120628" target="_hplink">walked the least</a> in the study, Reuters reported.
Nosh On Apples And Blueberries
Apple, pear and blueberry eaters have lower risks of Type 2 diabetes, according to a study in the <em>American Journal of Clinical Nutrition</em>. The study was based on the diets of 200,000 people. HuffPost Canada reported that anthocyanins and fruits rich in anthocyanins were linked with <a href="http://www.huffingtonpost.ca/2012/03/19/apples-and-blueberries-diabetes_n_1362405.html" target="_hplink">lower diabetes risk</a>; flavanoids, however, were not.
Get Your Rest
A <a href="http://care.diabetesjournals.org/content/early/2011/09/19/dc11-1093.abstract" target="_hplink"><em>Diabetes Care</em> study</a> from Children's Hospital of Philadelphia researchers showed that for obese teens, <a href="http://www.huffingtonpost.com/2011/09/20/sleep-diabetes-obese-teens_n_972505.html" target="_hplink">getting enough shut-eye</a> is linked with a lower risk of developing Type 2 diabetes. Researchers conducted the study on 62 obese teens. They found that sleeping between seven-and-a-half and eight-and-a-half hours a night was linked with stable glucose levels. But sleeping more or less than that was <a href="http://www.ottawasun.com/2011/09/20/lack-of-sleep-in-obese-teens-can-lead-to-diabetes-study" target="_hplink">linked with higher glucose levels</a>, the <em>Ottawa Sun</em> reported.
Eat Your Greens
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Moderate Alcohol Consumption (For Some)
Drinking alcohol at a moderate level is linked with a <a href="http://www.reuters.com/article/2011/11/24/us-health-carbs-idUSTRE7AN1TW20111124" target="_hplink">lower risk of Type 2 diabetes</a> for some people, according to <a href="http://www.ajcn.org/content/early/2011/11/01/ajcn.111.023754" target="_hplink">an <em>American Journal of Clinical Nutrition</em> study</a>. Harvard researchers found that for women with refined carb-heavy diets, moderate alcohol consumption is linked with a decreased diabetes risk of 30 percent, compared with non-imbibing women who eat similar diets, Reuters reported. "If you eat a high carb diet without drinking alcohol, your risk of developing diabetes is increased by 30 percent," study researcher Frank Hu <a href="http://www.reuters.com/article/2011/11/24/us-health-carbs-idUSTRE7AN1TW20111124" target="_hplink">told Reuters</a>. "However, if you eat a high carb diet, but (drink) a moderate amount of alcohol, the increased risk is reduced."
Chinese researchers found earlier this year that coffee may stop a protein <a href="http://diabetes.webmd.com/news/20120113/why-coffee-may-reduce-diabetes-risk?page=2" target="_hplink">linked with Type 2 diabetes</a> from building up, thereby possibly lowering the risk of the disease, WebMD reported. The research, published in the <em>Journal of Agricultural and Food Chemistry</em>, suggests that three particular compounds found in coffee are able to <a href="http://diabetes.webmd.com/news/20120113/why-coffee-may-reduce-diabetes-risk?page=2" target="_hplink">have this beneficial effect</a>: caffeine, chlorogenic acid and caffeic acid, according to WebMD.
Diabetes Risk Factors
Learn how to live healthy with diabetes - What risk factors are there for diabetes?