An analysis of diabetes-related clinical trials, published on April 5 in Diabetologia, provides insight into how diabetes is studied around the world and found "that the current portfolio does not adequately address disease prevention, management or therapeutic safety."

The analysis of 2,484 interventional trials registered through ClinicalTrials.gov from 2007 to 2010 unveiled that the majority of diabetes-related clinical trials have a therapeutic purpose (74.8 percent), while only 10 percent had a primarily preventative focus. Of the interventions, 63.1 percent were drugs and only 11.7 percent were behavioral.

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According to the authors, "the current trials portfolio, comprising studies with smaller sample sizes and shorter durations, appears to be inadequate for expanding and refining preventive efforts or translating effective care strategies into the community setting."

The study also found that cardiovascular outcomes are not a significant focus of diabetes trials. "Only a tiny proportion of the trials analyzed—1.4 percent—listed primary outcomes including mortality or clinically significant cardiovascular complications," noted Jennifer Green, MD, one of the study's authors.

Additionally, the age of patients enrolled in trials raised some concerns. Almost 30 percent of U.S. residents 65 years and older had diabetes in 2010. While older people are at the greatest risk of diabetes, only 0.6 percent of diabetes trials targeted patients 65 years old and above and 30.8 percent excluded anyone older than 65 years old. Even though there is an upward trend in type 2 diabetes among adolescents, only 3.7 percent of trials targeted people 18 years old and younger. "To achieve the greatest impact upon clinical care, trials should enroll patients representative of populations disproportionately affected by diabetes and its complications," said Green.

Globally, an estimated 366 million people—8.3 percent of the world's population—have diabetes mellitus, and this number is expected to grow to more than 552 million people by 2030. In 2011, diabetes and complications stemming from the disease cost $223 billion in North America and the Caribbean.

Keywords: North America, Health Resources, Caribbean Region, Diabetes Mellitus, Type 2, Cost of Illness

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