Before we review what’s going on in diabetes clinical trials let’s review the basics of clinical trials for our new readers.
What is a clinical trial?
A clinical trial is scientific research involving people that studies the effects of a new medication, therapy or device to determine if it is safe and effective.
In the United States, clinical trials are monitored by the Food and Drug Administration.
The Phases of a Clinical Trial:
Phase I evaluates dosage parameters.
Phase II continues to evaluate safety and begins to study efficacy.
Phase III compares the new drug with standards of care or if there are none, a placebo.
Phase IV is used if the drug normally used as a standard is to be used for another condition or if the formulation is changed. This phase may also be used for extended studies on drug side effects.
Diabetes clinical trials may involve studies of prevention of diabetes or the treatment of diabetes.
Types of Diabetes Clinical Trials
- Action studies (doing something) – These focus on finding out whether actions people take, such as exercising more or quitting smoking, can prevent diabetes or their impact on current diabetics.
- Agent studies (taking something) – These studies examine whether taking certain medicines, vitamins or food supplements (or a combination) have an affect on preventing or treating diabetes.
Why Participate in a Clinical Trial?
People participate in clinical trials for many reasons including the opportunity to try new cutting edge therapies under the care of leading researchers and health care providers, and for the opportunity to contribute to research to help themselves and others.
Clinical trials do have side effects including the possible negative effect of the therapies and/or no effects at all and they can be more time consuming than originally anticipated.
If you are considering participating in a clinical trial not only is it important to explore all facets of the trials through informed consent, but it is important to determine the cost and funding of a clinical trial and how your insurance coverage or Medicare comes into play. While often the medication being tested is free, there may be additional costs such as lab tests and hospitalization which are not.
Get answers ahead of time.
In depth resources on clinical trials and registries for clinical trials:
World Health Organization International Clinical Trials Registry Platform. “The mission of the WHO Registry Platform is to ensure that a complete view of research is accessible to all those involved in health care decision making.”
CRISP, Computer Retrieval of Information on Scientific Projects. “A biomedical database system containing information on research projects and programs supported by the Dept. of Health and Human Services.”
American Diabetes Association provides basic information on clinical trials.
Juvenile Diabetes Research Foundation International lists current JDRF funded clinical studies and provides information on what phase those studies are currently in.
The Children With Diabetes site lists current clinical trials.
Community Research is looking for volunteers who would like to participate in a clinical research study of an investigational medication for people with Diabetic Leg Pain or Diabetic Neuropathy.
If you (or someone you know 18-70 years old) have Diabetes or Diabetic Neuropathy and suffer from leg pain, do not have cancer, glaucoma, or a major psychiatric disorder and meet additional criteria, you may be able to participate in a clinical trial of an investigational medication for people with Diabetic Neuropathy.
If you qualify for this study, you will receive:
- Study related procedures provided at no cost
- Study related physical examinations and lab tests
- Monitoring and ongoing evaluations throughout the study
- Financial compensation for participation and travel up to $400
- The Natural History Study of the Development of Type 1 Diabetes: This study screens and observes relatives of people with type 1 diabetes to learn more about how the disease occurs.
- The Oral Insulin for Prevention of Type 1 Diabetes Study: This study tests whether a daily oral insulin capsule can prevent or delay the disease in at-risk relatives of people with type 1 diabetes.
- CTLA-4 Ig (Abatacept) in Recent Onset Diabetes: Currently testing the drug abatacept, which is already being used to treat rheumatoid arthritis, to try to protect remaining insulin production.
Joslin Diabetes Center has a variety of clinical trials now recruiting, including:
BARI 2D-Bypass Angioplasty Revascularization Investigation 2 Diabetes. This is a five year study of cardiovascular disease in type 2 diabetes. Some medications (FDA approved) available through the study. Glucose monitor and strips now available.
- A positive stress test or angina symptoms that require evaluation by cardiac catheterization.
- Type 2 diabetes
- Age >25 years
- HbA1c <13%
Check out the Joslin site for more information.