The increased understanding of the pathophysiology of type 2 diabetes (T2D) has led to the development of new drug classes with novel mechanisms of action, such as those based on incretin hormones. Despite these advancements in medical therapy, the first-line treatment for most T2D patients is metformin, an oral antihyperglycemic medication that became commercially available in Europe in 1972.1
As T2D is progressive, most patients will require treatment intensification to achieve recommended glycemic (HbA1c) levels. This typically involves combination therapy of two or more oral medications or escalation to injectable therapies (insulin or GLP-1 receptor agonists).2 Combination therapies or transition to GLP-1 receptor agonists or insulin can introduce new side effects, such as vomiting or diarrhea in the case of GLP-1 receptor agonists or hypoglycemia and weight gain as is the case with insulin.3
“Many patients don’t want to use insulin. They don’t want to do finger sticks and they’re afraid of hypoglycemia.” Prof. Harold Lebovitz, State University of New York Health Science Center, Brooklyn, New York
However, treatment intensification may not reduce HbA1c to the desired level, as the side effects may cause patients to skip doses.4 Lack of patient adherence to treatment regimens remains a clinical challenge, with over 50% of T2D patients not taking their oral antihyperglycemic medication.5,6 With smaller-sized needles and pre-mixed formulas, adherence to insulin has improved over the last several years but remains sub-optimal at 62%-64%.7
Diabetes places an enormous burden on the global healthcare system. Worldwide healthcare expenditures totaled US$612 billion in 2014.8 The majority of these costs are not related to T2D medication. Rather, hospitalizations for diabetes-related side effects (e.g., hypoglycemia) and complications (e.g., heart attack, kidney failure, etc.) comprise the bulk of diabetes healthcare expenditures.9,10 Costs are expected to rise, driven by an increasing overweight and obese population and a subsequent rise in global diabetes prevalence.11,12
“To fight the global diabetes pandemic, we would ideally have an accessible cost-effective easily-compliant intervention that has high clinical efficacy and that is free of adverse side effects.” Prof. Harold Lebovitz
While there have been remarkable advancements in recent years, there continue to be deficits in T2D therapies. An optimal treatment would meaningfully reduce HbA1c, minimize patient adherence as a factor in treatment efficacy, and have minimal side effects. If this were achieved, the consumption of healthcare resources—including the amount of time that healthcare providers spend on T2D management—could be significantly reduced while improving the lives of millions of patients.