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

by Vanita Aroda, MD, Scientific Director, MedStar Community Clinical Research Center
April 24, 2017

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.

Category: Innovations     Tags: diabetesdiabetes-medicationsdiabetes-treatmentmetformintype-2-diabetesvanita-aroda