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Three breakthrough products were approved by the FDA at the beginning of June:
  • Novo Nordisk’s Wegovy (semaglutide) for weight loss
  • Biogen’s Aduhelm (aducanumab) for Alzheimer’s Disease
  • Pfizer’s PREVNAR 20 (pneumococcal 20-valent conjugate vaccine) for the prevention of pneumonia

We had an informative Q&A session with Dr. Michael Koren recently to discuss the recent flurry of FDA approvals of medical products that were developed and then studied at ENCORE Research Group sites.

Q: Dr. Koren, how do you feel about these FDA approvals?
A: It is so gratifying to see the work of ENCORE Research Group’s dedicated people to help make these products available to the general public. Having experience with these products over several years makes me feel comfortable that the FDA made a sound decision.

Q: Can you comment on what it was like to be Principal Investigator for the Wegovy (semaglutide) clinical trials?
A: The understanding of metabolism and how that affects appetite represents a major advance in medicine. Patients who have been working with us over the last five years have had advanced access to semaglutide and many of my patients have had profound weight loss and improvement in their cardiovascular risk factors. It’s quite gratifying to see that this product will now be more broadly available.

Q: Are there any lessons for the general population?
A: The approval of these drugs exemplifies how our patients (ENCORE Community)
have access and opportunities to use medical products before they are available to the general public. In many cases these products provide advantages that are not seen with products already on the market. The fact that patients can get access to these products (or not, in a placebo-controlled environment) without any cost and with the extra benefits of the incredible dedicated staff that we have is perhaps my most gratifying experience.

Q: What’s the next semaglutide?
A: Yogi Berra always said “it’s tough to make predictions, especially about the future.” But even with my crystal ball low on batteries, I have a feeling that it will be major breakthroughs in the lipid space; the most exciting news since statins first came out. We know that the PCSK9 protein is a bad actor. We are excited because we have data from outcome studies that show decreased cardiovascular risk with the PCSK9 inhibitor therapies, Repatha and Praluent, however these therapies are expensive and difficult to make. New lipid therapies that we are studying include adnectins that neutralize the PCSK9 protein once secreted by the hepatocytes (liver cells). Other new therapies prevent the production of the PCSK9 protein in the first place, including siRNA (small interfering RNA) and ASOs (antisense oligonucleotides). siRNA are used to silence the gene that creates the PCSK9 protein. ASOs target and inhibit the source of PCSK9 protein production.

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You may have heard that people with diabetes are at a higher risk of contracting COVID-19. This is not the case. The truth is, people with diabetes are more likely to experience severe illness, long lasting effects, or even death if they are infected with COVID-19.

What We Know about Diabetes and COVID-19

In May, a nationwide multicentre observational study called the CORONADO study, observed the mortality risk in people with diabetes who were hospitalized for COVID-19.  The study population was 88% type 2 diabetics and 12% type 1 diabetics.  What they found was that one in ten diabetic patients hospitalized with COVID-19 died within seven days of hospital admission. One in five died within the first 28 days.

How Can We Improve These Numbers?

  • Metformin – Recent studies have shown that metformin decreased the mortality rate of diabetic patients with COVID-19. Those who took metformin had an 11% mortality rate compared to 24%  with type 2 diabetes who were not taking metformin when admitted to the hospital. These studies heavily indicate a strong, positive relationship between metformin, COVID and diabetes.
  • Vaccine – another way to protect those battling diabetes from COVID-19 is to consider getting the vaccine. There have been three emergency use authorized vaccines:  Pfizer, Moderna, and Johnson & Johnson.  Each vaccine appears to be safe and effective in adults with diabetes. Rigorous clinical trials tested these vaccines for safety in adults of all ages, races and ethnicities and chronic health conditions.
              • How will the vaccine affect blood sugar levels?
                • Receiving the vaccine can cause symptoms of illness that can increase your glucose levels. However, if carefully monitored and correctly hydrated side effects can be minimal.
              • Do diabetes medications affect the vaccine?
                • Currently, there is no evidence to suggest that the COVID-19 vaccine will interact with current medications. However, it may be helpful to avoid injecting insulin or placing a glucose sensor near your vaccine injection site for several days after receiving the vaccine. 
              • Should I get vaccinated if I have diabetes and other health conditions?
                • Complications of diabetes include heart disease and kidney disease.  These conditions put one at higher risk or death from COVID-19. 
                • Vaccination should be a priority for patients with type 2 diabetes who are at very high risk of severe COVID-19 to help protect this vulnerable population.

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December 1, 2017 BlogDiabetes

As I was perusing an ancient text I came across an excerpt on the disease known as diabetes.  The earliest mention of the disease I could find was by a Greek physician called Aretaeus in the first century AD.  Aretaeus identified diabetes and named it after its symptoms of thirst and sweet urine.  When I researched the period I was astounded to find the diagnosing physicians were called “water tasters” and would either taste the urine or see if insects were attracted to it.

My research revealed that diabetes wasn’t well understood until the 20th century.  It was then that researchers discovered insulin from the pancreas helped control blood sugar levels.  A few decades later in 1961 the researchers at Ames Diagnostics created the first blood sugar monitor. This monitor was called Ames Reflectance Meter and was only available in doctor’s offices and hospitals due to its cost. Around this time a pioneering man named Richard Bernstein mounted a campaign to make blood sugar monitoring at home acceptable and easy. He was so passionate about the cause, at the age of 45 he went to medical school and became an endocrinologist. His efforts here led to millions of people being able to monitor their blood sugar at home. Now information about diabetes is growing exponentially. The thought that all of this diabetes research led from tasting urine to affordable blood sugar measuring is amazing!

At ENCORE research, we are passionate about advancing health care.  Without research, we wouldn’t have these advances in diabetes management!


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March 1, 2017 BlogDiabetes

Many doctors prescribe metformin to diabetic patients. Doctors trust the drug, particularly since the landmark United Kingdom Prospective Study that showed that overweight Type 2 diabetics on metformin lived longer and suffered fewer heart attacks than those with the same blood glucose levels achieved using insulin. The history of metformin provides a good example of how an unusual herb can become a powerful treatment. 

Metformin originates from the plant Galega officinalis or French lilac, goat’s plant or goat’s rue. This plant was fed to goats to improve milk production.  It grows as a perennial herb, 3 feet tall, with purple, blue or white flowers and was used in the Middle Ages to treat frequent urination, a side effect of diabetes. The Native American Seminole tribe used the insecticide roterone, found in the roots of Galega officinalis, in fishing. Fish were stunned by roterone, and were much easier to catch. This plant has powerful properties and is now widely considered poisonous. 

Metformin was first described by scientists in 1920. Chemists found that they could make the active compound from this plant, guanidine, more tolerable to be ingested by bonding two guanidines together forming a biguanide. This compound, which could lower blood sugar, was first synthesized in 1929.  However, insulin had also been discovered during this time and became the more popular option for controlling blood sugar.  Metformin was neglected and ignored until 1950 when metformin was used to treat influenza. Doctors noted metformin decreased glucose levels.  

In 1958, Metformin was finally released in the United Kingdom as a treatment of lowering blood sugars.  This drug was clinically developed and called Glucophage (“glucose eater”). Glucophage was released in the United States in 1995 and quickly became a popular medicine.  Finally after half a century, it’s potential was realized. Metformin has now become the world’s most widely prescribed anti-diabetic agent and is universally recommended as the first therapy for Type 2 diabetes. 

Metformin works by lowering the rate of hepatic glucose production, which is three times higher in people with Type 2 diabetes.  Probably through reduction of insulin resistance, metformin can reduce cardiac risk factors and may decrease cardiac events. Since metformin does not cause hypoglycemia (low blood sugar), it can be safely utilized in a variety of diseases such as pre-diabetes, gestational diabetes, polycystic ovary disease, sleep apnea, osteoporosis and cancers. 

Metformin’s has also been noted to have a positive effect on longevity due to its anti-cancer effect.  Since having Type 2 diabetes is a major risk for developing cancer (pancreas, bladder, ovary, breast, prostate, colon and liver) patients with Type 2 diabetes have a lower risk of developing these cancers if they are utilizing metformin. 

This very economical and widely available medication has been shown to safely treat multiple diseases in addition to Type 2 diabetes and to improve longevity in both the diabetic and non-diabetic patient. Metformin has come a long way from its humble “roots”.  Fortunately, research rediscovered this powerful perennial herb. And now metformin has ascended to being the drug of first choice for patients with Type 2 diabetes.


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February 1, 2017 BlogDiabetes

The word “tsunami” describes a huge wave caused by an underground disturbance.  Diabetes falls under that definition in our view.   According to a study in Diabetes and Endocrinology, two out of five American adults may develop Type II Diabetes in their lifetime.  About 95% of US diabetics are Type II. Type II diabetes occurs due to a condition of insulin resistance. Insulin, a hormone produced in the pancreas, does not have a sufficient effect on blood sugar levels, despite high levels of production in Type II diabetics.  Fortunately, thanks to clinical research, surviving this diabetic tsunami should soon become easier. New research breakthroughs may lead diabetes to “dry land.”

For those currently battling diabetes, recent technological breakthroughs may make pricking your finger a thing of the past! Researchers at Arizona State University developed a method of testing glucose through saliva. To use, one simply licks a biosensor strip. The biosensing device then uses an electrochemical analysis to calculate blood glucose levels instantly. The company overseeing the development of this technology hopes to have it on the market in the next few years.

While tracking your blood sugar should become simpler, new ways of taking your diabetes medication may help keep diabetics afloat. Scientists have developed a “smart patch” that contains live pancreatic beta cells.  A “smart patch” uses a system of tiny needles – each about the size of an eyelash, to detect high blood glucose levels and automatically inject insulin when needed. The live beta cells used in the newest versions of the smart patch can control rising blood glucose levels for roughly 10 hours at a time. Since the beta cells stay outside of the body on the patch, one’s body should not reject the cells. Current testing has been successful in mice studies, but the patch has yet to be tested on humans.  Maybe one day we will seek volunteers for the “smart patch” at all of our seven research sites!

Another interesting diabetes finding comes from researchers at the Ottawa Hospital. Scientists turned from puzzled to amazed when they discovered a bacteria-killing protein in the pancreas. The bacterial-killing protein called cathelicidin antimicrobial peptide (CAMP) is produced by the same cells that produce insulin. Hoping to find a link between CAMP and diabetes, they injected diabetes-prone rats with CAMP. Not only did the rats have a healthier, more regenerated pancreas, but they had an increase in beneficial gut bacteria. CAMP could be a breakthrough in diabetes treatment.

Having diabetes is a big deal, and high sugar levels are themselves often less of a risk than other associated features of diabetes.  In fact complications, such as high cholesterol levels and weight gain can be more problematic. High levels of cholesterol increase your risk of having a heart attack or stroke. Weight gain leads to higher blood sugar levels, high blood pressure and arthritis in weight bearing joints. We have several studies which target these complications. Many studies targeting cholesterol are enrolling right now at any of our sites, so if you have diabetes, heart disease, or even just high cholesterol give us a call and we can find the right fit for you!  We also have a diabetes study enrolling with a medication that is said to cause weight loss at our Fleming Island, St. Johns, and Inverness offices. The future of diabetes management is looking bright!  These research studies and new technologies coming down the pipeline may be just the life raft you’ll need to stay afloat in the diabetic tsunami.


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