Future Intervention Trials in Type 1 Diabetes
- Terry Wilkin, MD1,
- Johnny Ludvigsson, MD2,
- Carla Greenbaum, MD3,
- Jerry Palmer, MD4,
- Dorothy Becker, MD5 and
- Jan Bruining, MD6
- 1Department of Endocrinology and Metabolism, Peninsula Medical School, Plymouth, U.K.
- 2Department of Pediatrics, Linkoping University, Linkoping, Sweden
- 3Department of Diabetes, Benaroya Research Institute, Seattle, Washington
- 4Department of Diabetes, VA Medical Center, Seattle, Washington
- 5Department of Pediatrics, Children’s Hospital of Pittsburgh, Pittsburgh, Pennsylvania
- 6Department of Pediatrics, Sophia Children’s Hospital, Rotterdam, the Netherlands
- Address correspondence and reprint requests to Terence J. Wilkin, MD, Department of University Medicine, Derriford Hospital, Derriford Road, Plymouth, Devon, PL6 8DH, U.K. E-mail: terence.wilkin{at}phnt.swest.nhs.uk
The recently completed trials using insulin (U.S.) and nicotinamide (Europe) were not effective in preventing type 1 diabetes (1,2), but they leave an important legacy of goodwill among their collaborators and expertise in the conduct of such trials and a network through which more may be carried out.
A commentary on the trials has recently been published (3), and its authors urge “a different combination.” Concerned that too little is known of early immune interactions to intervene effectively in infancy, when the disease is thought to start, they propose trials of combination or “cocktail” therapy to achieve immunosuppression in new-onset patients. The ultimate benefit to the pre-diabetic patient would come if it were possible to improve β-cell survival in the context of reduced inflammation. Antigen-based therapies, monoclonal antibodies, and other immunoregulatory and immunosuppressive agents are listed, built around confident assertions that type 1 diabetes “has an autoimmune basis” and that, given the success of combination therapy in cancer, AIDS, and systemic lupus erythematosus, “why should type 1 diabetes be any different?”
But what if type 1 diabetes is different? What if the paradigms are different? And they may be because, despite an immense research effort, the doubling of type 1 diabetes over the past 25 …
