Diabetes Clinical Trials: What Is New at NIDDK?

Controlled, randomized clinical trials are the foundation on which the American Diabetes Association (ADA) and other groups develop guidelines for diabetes care. The Diabetes Control and Complications Trial (DCCT)¹ provided definitive evidence that intensive glycemic control dramatically reduces the microvascular complications of type 1 diabetes. The United Kingdom Prospective Diabetes Study² provided similar findings for type 2 diabetes. The results of these trials formed the basis for ADA's current standards of care and led the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) and the Centers for Disease Control and Prevention (CDC) to create the National Diabetes Education Program (NDEP) to disseminate the new guidelines to providers and patients.³

As additional clinical trials demonstrated the importance of blood pressure and LDL cholesterol control in preventing vascular complications of diabetes, the NDEP expanded its focus to the “ABCs of diabetes”: A1C, Blood pressure, and Cholesterol. More recently, the Diabetes Prevention Program demonstrated that a 5-7% weight loss and modest physical activity (30 minutes a day, 5 days a week) reduced the development of type 2 diabetes by 58% over 2.8 years.⁴ In response, the NDEP launched its “Small Steps. Big Rewards. Prevent Type 2 Diabetes.” campaign, providing patients and providers with tools for lifestyle change. Additional information about this program is available at the NDEP Web site (www.ndep.nih.gov).

There are often significant differences between trials supported by industry and those supported with public funds. The nature of the intervention under study is one consideration. It is noteworthy that the seminal DCCT did not focus on specific medications and thus would not have been undertaken by industry. Another consideration is the size of the group affected by a disease. While there is a large and unfortunately rapidly expanding market for type …