Are Type 2 Diabetes Clinical Trials Wasting Time and Money?
Type 2 diabetes is often called a disease of lifestyle because it is associated with being overweight or obese, lack of physical exercise, high blood pressure, high cholesterol, and poor diet, all factors that involve lifestyle choices. Yet only 10 percent of type 2 diabetes clinical trials focus on prevention while nearly 66 percent focus on drug therapy. Are these trials wasting time and money while a growing number of people, especially children and adolescents, could benefit more from help in preventing it?
Do we really want to prevent type 2 diabetes or just treat it?
It seems logical to focus attention on factors of a disease that can provide the most benefit and impact. Therefore, when faced with a disease of lifestyle (and therefore factors individuals can take action on themselves), the most efficient and productive use of time and resources would be to focus on prevention rather than sink decades of research and development and hundreds of millions of dollars into drug development.
Yet that’s exactly what has been going on in the world of clinical trials for type 2 diabetes. According to the results of new research published in Diabetologia, only 10 percent of the 2,484 interventional trials for type 2 diabetes registered with ClinicalTrials.gov from 2007 to 2010 focused on prevention of this lifestyle disease.
Is this effective use of research time, dollars, and effort? Shouldn’t most of the efforts target how to help individuals prevent the disease and if it does develop, how to manage it effectively with minimal or no use of expensive pharmaceuticals with side effects?
Dr. Jennifer Green of Duke University Medical Center in Durham, North Carolina, and her colleagues evaluated the data from the trials. They found that:
- 63% of the trials focused primarily on drug interventions
- 12% of the trials focused on behavioral changes
- Only 10% explored preventive measures
- Less than 1% of trials specifically focused on people age 65 years and older, even though nearly 20% of adults in this age group have diabetes
- Nearly all the trials excluded people older than 75 years old, even though adults in this age group are especially vulnerable to type 2 diabetes complications
- Most of the studies were small or medium and had fewer than 500 participants (91% of trials), numbers that do not provide the best information for analysis
- Most of the trials were of short duration, averaging 1.4 to 1.8 years
- Trials are not being conducted to match the prevalence of diabetes in a given country. For example, despite high prevalence of diabetes in six Middle Eastern countries as well as Brazil and the Russian Federation, these countries have relatively few registered trials compared with the United States, China, India, and Mexico.
Diabetes, and especially type 2 diabetes, is an epidemic, affecting an estimated 371 million people around the world now and growing to about 550 million by 2030. Can we hope to effectively fight this disease if the majority of research efforts focus on dispensing drugs to people instead of helping them prevent the disease or manage it better without medication?
The majority of the current clinical trials for type 2 diabetes are problematic for many reasons, including the fact that they include “small numbers of participants, exclude those at extremes of age, are of short duration, involve drug therapy rather than preventive or non-drug interventions, and do not focus upon significant cardiovascular outcomes,” noted Green.
In other words, is the public being best served by current type 2 diabetes clinical trials? Are type 2 diabetes clinical trials wasting time and money?
Lakey WC et al. Are current clinical trials in diabetes addressing important issues in diabetes care?” Diabetologia; doi:10.1007/s00125-013-2890-4