Type 2 diabetes is a chronic medical condition in which the body cannot use insulin properly, causing glucose (or sugar) to build up in the blood. Over 40.1 million people in the U.S. have diabetes, with 90 to 95 percent of them having type 2 diabetes.
Black Americans, in particular, are disproportionately affected by type 2 diabetes, as they are nearly twice as likely to develop the chronic condition as white adults. Potential risk factors include socioeconomic status, physical activity, and an unhealthy diet. Additionally, structural racism plays a role in type 2 diabetes disparities for Black communities.
Type 2 diabetes clinical trials are vital to advancing care for individuals who are diagnosed with the condition. The more the healthcare system can learn about how the condition impacts Black Americans, the better it can serve these underserved communities.
To determine the safety and efficacy of a medication or treatment, a research team conducts clinical trials with volunteers, ideally from diverse backgrounds.
Clinical trials typically consist of four phases:
In the initial phase of a clinical trial, researchers are focused on safety, dosing, and side effects. They will test a small group of participants, usually fewer than 100.
In Phase 2, researchers expand the group to about 100 to 300 individuals and continue testing safety, efficacy, and side effects.
In this phase, the drug or treatment is now administered to a much larger group of people, typically around 1,000 to 3,000. In this phase, researchers compare the treatment with other standards of care, monitor side effects, and continue to track participants.
The U.S. Food and Drug Administration (FDA) has approved the drug, and it can now be sold to the public. This phase can last for decades as researchers continue to monitor the treatment’s efficacy and long-term safety.
RELATED: Early-Onset Type 2 Diabetes May Be Reversible With Lifestyle Changes
Clinical trials for diabetes care date back to 1922, when researchers administered the first insulin injection to a patient with type 1 diabetes. Over the past century, the treatment of diabetes has only grown, changing the way the healthcare system is able to support and treat diabetes patients.
Some important developments include:
Olubukola (Bukola) Okoro, MD, is triple board-certified in internal medicine, obesity medicine, and lifestyle medicine, and founder of RescueMD. For healthcare experts like Dr. Okoro, clinical trials have altered the path of diabetes care.
“[Clinical trials] changed what we are even aiming at,” Dr. Okoro tells BlackDoctor. “For decades, the goal was simply a lower blood sugar number, because that is what the early trials measured. The cardiovascular and kidney outcome trials of the last ten years asked a different question: ‘Does this drug keep people alive, out of the hospital, and off dialysis?’ and the answers rewrote the guidelines.”
As previously mentioned, Black Americans experience significantly higher rates of type 2 diabetes than white Americans. Between 2021 and 2023, the rate of diagnosed diabetes in Black Americans was 12.2 percent. In addition, Black individuals face higher rates of complications and are twice as likely to die from diabetes as white individuals. In less severe cases, they are more likely to end up hospitalized from complications, face leg or foot amputations, and be diagnosed with end-stage kidney disease.
Despite Black communities experiencing a disproportionate burden of type 2 diabetes, they are underrepresented in clinical research, Dr. Okoro explains.
“Black patients have historically been a small fraction of the people enrolled in the trials that decide how that disease gets treated,” Dr. Okoro says. “Drugs can differ in how they work across groups, and the things that decide whether a treatment actually succeeds in real life – diet, cost, insurance, access to a pharmacy, whether anyone follows up with you – look different depending on where and how you live. If a trial population does not include your community, we are extrapolating, and I would rather have the data.”
Participating in a type 2 diabetes clinical trial can offer several benefits for people living with diabetes, including:
Scott Nass, MD, a family medicine physician at SwiftCareMD, explains how participating in a clinical trial can benefit not only the individual but also the community.
“Some participants will receive better monitoring, extra education, and the opportunity to receive an experimental treatment or program for their diabetes,” Dr. Nass tells BlackDoctor. “They will also help researchers identify ways to improve diabetes treatment and prevention for future patient populations.”
Dr. Okoro also emphasizes three main benefits: attention, access, and representation.
“Your data counts for someone who looks like you,” Dr. Okoro adds. “The reason we can say a drug works in Black patients is that Black patients were in the trial.”
Not every type 2 diabetes clinical trial is the same. Some trials test medications and weight-management tools, while others focus on health-related tech and prevention strategies.
Researchers test new and existing medications to determine their efficacy. This usually includes a medication’s ability to lower blood sugar, increase insulin sensitivity, or reduce the body’s need for insulin. These trials also assess potential side effects.
Researchers study different approaches to weight loss, such as dietary changes, exercise, behavioral counseling, and weight-loss medications.
Researchers evaluate diabetes technology, including continuous glucose monitors (CGMs), insulin pumps, and mobile health apps, to see whether it helps patients manage blood sugar and make health-related decisions.
Researchers investigate ways to prevent or delay type 2 diabetes in individuals with prediabetes and other risk factors. These include lifestyle interventions, nutrition, exercise, and medications.
Researchers explore treatments and prevention strategies for complications related to diabetes, such as kidney disease, heart disease, nerve damage, and diabetic retinopathy.
If you or a loved one is interested in participating in a type 2 diabetes clinical trial, here are a few resources to consider:
RELATED: How to Find a Clinical Trial That Actually Works for You
Eligibility for diabetes clinical trials depends on factors such as age, diabetes type, medications, and overall health. Participants always have the right to informed consent, privacy, and to withdraw at any time without penalty.
If safety and medical mistrust concern you or your loved one, note that all clinical trials require oversight from institutional review boards (IRBs) and prioritize participants’ health.
According to Dr. Nass, it is helpful for a participant to understand the aims of the study, its potential risks or benefits, the anticipated length of time, the anticipated cost, and any differences from your current treatment.
“You may also want to find out what is expected of you if you experience side effects from either the medication being tested or from any other medications being used,” Dr. Nass adds.
Black Americans have been historically underrepresented in clinical trials, including trials for conditions that disproportionately affect them, such as type 2 diabetes. If you or a loved one has type 2 diabetes, or you’re interested in participating in a clinical trial for the condition, we recommend speaking with your primary healthcare provider to see whether a trial could be the right choice for you.
For Dr. Okoro, the biggest piece of advice is to understand that a clinical trial is research, not treatment, and to source a credible study.
“A legitimate trial is registered on ClinicalTrials.gov, is reviewed by an ethics board, and will never ask you to pay to take part,” Dr. Okoro says. “Bring the information to your own physician and talk it through. Any good study team will be glad for you to do that.”
Yes. Eligibility may vary by trial, but people currently taking diabetes medication can often participate.
Like most clinical trials, the timeline varies, especially depending on which phase of the trial you join. Some can take as little as a few hours for a single visit, while long-term studies can last over five years.
Yes. Older adults are encouraged to participate in diabetes clinical trials because this fast-growing population needs more research.
Yes, however, your eligibility will depend on the specific study. Some trials may accept mild to moderate complications, while others may exclude those with advanced complications in order to ensure patient safety.
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