In 2008, Ralph DeFronzo was awarded the Banting Medal by the ADA and in his lecture published in 2009, he claimed that the ADA/EASD treatment of T2 diabetes was a recipe for failure. Instead, he proposed starting T2s on triple combination therapy upon diagnosis (Metformin, TZD and GLP-1) and when that failed, simply move to insulin. His claim was that the ADA/EASD stepwise protocols were not durable and that over time the end result was progression of beta cell loss and progression of diabetes.
Surprisingly, his challenge was taken up by the ADA which funded a clinical trial of his protocol and the first results are in and have been reported at the ADA 73rd Scientific Sessions.
CHICAGO — A novel approach of starting newly diagnosed type 2 diabetes patients on 3 therapeutic agents simultaneously, in this case metformin, pioglitazone, and the glucagonlike peptide-1 (GLP-1) agonist exenatide (Byetta, AstraZeneca/Bristol-Myers Squibb Alliance), showed greater and more durable reductions in HbA1c, less hypoglycemia, and less weight gain compared with conventional, stepwise add-on treatment with metformin, a sulfonylurea (glyburide), and basal insulin (glargine), in a new study reported today here at American Diabetes Association (ADA) 2013 Scientific Sessions.
The results of this so-called "triple therapy" were hailed as potentially revolutionary and possibly "paradigm shifting," although questions remain.
Muhammad A. Abdul-Ghani, MD, from the University of Texas Health Science Center at San Antonio, presented the findings. He told Medscape Medical News: "We think this might be clinically meaningful and, hopefully, in a larger study, it might show differences in the risk of microvascular complications, and that definitely will be [practice] changing, in terms of guidelines and the approach to treating patients."
With conventional therapy for diabetes, where individual drugs are added 1 at a time and a second is only started when it is deemed needed, "the HbA1c starts to slide over time," Dr. Abdul-Ghani observed. "But with the triple therapy, at 6 months and at 2 years, our patients had exactly the same HbA1c."
Those patients who have reached 3 years of therapy in the study, which is ongoing, have maintained the same HbA1c, "and we intend to extend the study beyond 3 years," he noted. "So far, there is no other therapy that has shown such a durable and stable reduction in HbA1c," but how long this will continue to be the case remains to be seen, he acknowledged.
For more information read the medscape release.