Type 2 diabetes trial offers chance to further research, treatment understanding

Some people with Type 2 diabetes can manage the disease with diet and exercise alone. Others need medication, in addition to lifestyle management, to reach their target blood sugar levels, and many will eventually need two or more medications.

Studies have demonstrated how these medications perform over a short period of time. But we currently don’t know which of these drug combinations works best long-term.

An ongoing study, following participants for up to seven years, is looking to change that, and District of Columbia and Baltimore-area residents are helping in the effort. The Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness (GRADE) study aims to enroll 5,000 participants at 45 sites across the country. Along with helping advance our understanding of how best to treat this disease, participants also receive medication and supplies, clinic visits, lab tests and education during the trial.

As of March 1, 2017, nearly 4,400 people were enrolled in the study, and about 200 are from the D.C. and Baltimore area, ensuring that the study’s findings will be representative of our surrounding community. To help reach the 5,000-participant goal, we are recruiting more people in the area with type 2 diabetes to join.

Are you eligible? To learn whether you qualify to join the GRADE study at MedStar Health Research Institute, call 301-560-2915, email [email protected], or take our survey here.

 

Who is a candidate for the study, and what benefits may they see?

GRADE study participants represent patients with type 2 diabetes who have had diabetes for less than 10 years and are currently managed on metformin. The GRADE study is making a focused effort to enroll participants from a wide range of ages, race and ethnicities, and across a broad geography.

Volunteers may be eligible to participate in GRADE if they meet the following criteria:

  • Have had type 2 diabetes for fewer than 10 years
  •  Are older than 30 years of age, or 20 if American Indian
  • Only take metformin (Glucophage) for your diabetes
  • Are willing to take a second diabetes medication
  • Are willing to make four office visits per year for the next four to five years

In the GRADE study, as with other studies conducted here, the care provided in the study does not replace the usual care participants receive from their doctor, but rather complements it. In the study, participants have their glucose control checked (through a blood test called the HbA1c) every three months. During the visits, the study teams works very closely with the participants to help reach good diabetes control.

Current Type 2 diabetes medications

When patients need help beyond diet and exercise to manage their Type 2 diabetes, the medication metformin is usually the first-line choice of treatment. Metformin helps the body respond to insulin more effectively, reduce glucose production in the liver, and decrease the amount of glucose absorbed in the body.

Metformin has been used in the U.S. since the mid-1990s, and among drugs used to treat diabetes, it has the most evidence to date in terms of long-term safety and benefits. Nonetheless, diabetes is a progressive disease. Beta cell function, or pancreatic function, tends to deteriorate over time in diabetes, so many patients eventually will need to add a second medication to help control glucose levels. It is important to maintain good glucose control to minimize long-term complications related to diabetes, such as nerve, eye and kidney damage.

It can be a challenge to determine which of the current available medications is the best choice to give patients along with metformin. There are a limited number of studies that have been able to compare the many choices we have available.

When additional medications need to be added to control blood sugars, a number of factors are considered, including the medication’s:

  • Cost.
  • Safety profile. For example, does this medication increase the risk of having a low blood sugar reaction, or hypoglycemia?
  • Effectiveness. How effective is this medication in controlling blood sugars, and depending on where the patient’s levels of glucose control is, what is the likelihood of the medication getting them to their goal?
  • Complexity of treatment.
  • Likelihood of adherence.

We hope that the GRADE study will help us say with more certainty which treatment works best and for whom.

GRADE first long-term study of medication combinations

Previous studies have looked at the short-term effect of using different drugs along with metformin. The studies typically analyzed how effective drug combinations were in lowering A1C levels. A1C tests are used to understand how well-controlled diabetes is by measuring average blood sugar levels over several months.

Lowering a patient’s A1C is important, but the GRADE study takes it a step further. It is not only looking at A1C lowering but also determining which combination of drugs is most effective at achieving and maintaining diabetes treatment goals over the long term. Specifically, the goal of the GRADE study is to determine which combination of two diabetes medications is best for achieving good glycemic control, has the fewest side effects, and is the most beneficial for overall health in long-term treatment for people with type 2 diabetes. These types of questions cannot be answered in short-term studies, but require longer-term evaluation such as what is being done in GRADE.

Funded by the National Institutes of Health, the GRADE study will follow patients who take metformin along with one of four commonly used glucose-lowering medications: glimepiride, sitagliptin, liraglutide and basal insulin glargine. Each has a different mechanism of action and a different effectiveness and safety profile, and the GRADE study is the first study to directly compare all four treatment choices for this patient population.

This head-to-head comparison of commonly used diabetes medications will examine the effects on glucose levels, durability of maintaining treatment goals, and a number of other areas of interest, including effects on pancreatic beta cell function and quality of life. The study also is unique in that we’ll be able to look at how different groups of people react to the different combinations, which will ultimately help us better personalize treatment for each patient.

Nearly 1.4 million Americans are diagnosed with diabetes every year. With your help, this study will help current and future with type 2 diabetes in our community better manage their disease and stay healthy longer.

Down with Diabetes: How to Lower Your Risks

According to the CDC, 29 million people in the United States today have diabetes.  Worse, one out of every three children born here can expect to be diagnosed with the disease, at younger ages than ever before.

Yet the cause of this alarming trend often lies within our own hands.    

“The rise in diabetes mirrors the rise in obesity,” says Michelle Magee, MD, a practicing endocrinologist at MedStar Washington Hospital Center and an associate professor of medicine at the Georgetown University School of Medicine. “Over the last 25 years or so, we as a nation started walking less and eating out more. As a result, many incidences of diabetes today are related to lifestyle.”

Many, but not all. Type 2 diabetes – the most common type - does run strongly in families.  This means that your family genetics definitely play a role in whether you will get it or not. But Dr. Magee—who is also director of the MedStar Diabetes Institute’s clinical, education and research programs—concentrates on the risk factors that patients at risk for diabetes, known as pre-diabetes, or with diabetes can change and control.

The first step you can take is to know the numbers that tell you if you have pre-diabetes or diabetes.

Tune in to the full podcast interview with Dr. Magee.

There are two major blood tests that physicians use to help determine the presence or absence of diabetes…or the risk of developing it. The first is the fasting blood glucose (sugar) test. This provides a snapshot of how well your body is balancing what you eat and your physical activity at the point in time that your blood is tested.   The second, called the A1C test, measures the average amount of sugar in your blood stream over a two- to three-month period. In both tests, numeric results are broken down into ranges classified as normal, pre-diabetes or diabetes.

The good news is that risks and complications—as well as those tell-tale numbers—can often be driven downward by eating right and exercising regularly. Large national studies have proven that intensive lifestyle changes can reduce risk for going from pre-diabetes to diabetes by up  to 60 percent…and help prevent complications of diabetes itself.  This includes preventing blindness, kidney disease, nerve damage and limb amputation.  Lifestyle changes also help prevent cardiovascular disease, heart attack and stroke which are more common in people with pre-diabetes or diabetes than those without these conditions.   

For those living with pre-diabetes, “As little as a 7 percent weight loss can make a big difference,” Dr. Magee says.  “For a 200- pound person, that’s only 14 pounds. Exercising 30 minutes a day at least five times a week is also key.”    

Once you have diabetes, because it is a progressive disease, most patients will eventually need some form of medication. But this isn’t your grandfather’s treatment. Advances in research and technology have produced 12 different classes of pills and two classes of shots, with delivery systems ranging from needles to pens to patches to pumps. And even more drugs, approaches and management techniques are on the horizon. As a result of advances in diabetes treatments in the past 20 years, people living with diabetes are living well and with less problems from complications than used to be the case.

Even the best of modern medicine can get a boost from a patient’s personal efforts. Toward that end, education is key, so patients understand their readings, how to correct low or high blood sugar levels, what to eat and when, how to recognize side-effects from medication and more. Unfortunately, studies show that nearly 50 percent of patients with diabetes never get the grounding they need to understand their condition and what they can do.

Ever the educator and advocate, Dr. Magee urges people with diabetes to do their own “due diligence” into the disease, and take advantage of management and support programs offered by the MedStar Diabetes Institute and others within the community.

“My biggest message to patients is this: Learn about diabetes.  Then you can take control of it, versus it taking control of you.”

Tune in to the full podcast interview with Dr. Michelle Magee.

Healthy Habits for a Healthy Pregnancy

Managing Gestational Diabetes Yields Long-Term Benefits

Christine Leonard is the proud mother of three sons. With each child, she developed gestational diabetes during her pregnancy, which meant her blood sugar levels were too high. For Christine, she knew it was critical to eat right, exercise and carefully monitor her condition to have a healthy pregnancy.

“Each time, I was diagnosed early,” says Christine. “I was just very diligent about everything and made some lifestyle modifications."

Even after Christine delivered, it was important for her to maintain a healthy lifestyle, and here's why:  It is estimated that up to 10 percent of women with gestational diabetes are diagnosed with type 2 diabetes soon after delivery. Over 10 years, the risk can increase up to 50 percent.  But the risks can be mitigated if preventative screenings are scheduled. Yet, too many women are skipping the required postpartum glucose tolerance test, usually given to women six to 12 weeks after they’ve delivered. Recent studies show that up to 50 percent of patients do not show up for this important test.  The low compliance is likely because too many women are overwhelmed after bringing home a newborn baby and simply forget.

 Dr. Sara Iqbal, a high-risk obstetrician at MedStar Washington Hospital Center says, “Educating the patient and providing test reminders is essential in order to improve the rate of testing postpartum."

During her pregnancy, Christine followed the sound advice she received from Dr. Iqbal and to this day remains vigilant about her dietary changes.

“She was my model patient as she made the lifestyle changes that I asked,” says Dr. Iqbal. “This is very important because having gestational diabetes puts her at high-risk for developing type 2 diabetes later in life.”

Dr. Iqbal advises patients to:

  • Watch food portions and caloric intake
  • Avoid gaining too much weight as obesity is a major risk factor for type 2 diabetes
  • Continue to exercise
  • Follow up for the postpartum glucose tolerance test
  • Have your blood sugar levels tested every one to three years, depending on the glucose tolerance test results

“When I delivered my baby, the diabetes went away soon after, but I will be really aggressive about monitoring for the rest of my life,” says Christine.

From past experience, Christine knows that diabetes is easy to treat when caught early, before complications can occur, and most important, understands that type 2 diabetes can be prevented by simple, easily applicable lifestyle modifications. 

 

 

Have any questions?

We are here to help! If you have any questions about your pregnancy or would like to speak with a member of our Women's and Infants Services team call MedStar Washington Hospital Center at 202-877-3627.

Subscribe to Blog

Get health tips and the latest news in your inbox.