Diabetes is a major global health issue that affects millions of people worldwide. And trends suggest that is only going to get worse.

Consider these facts:
  • In 2011, 366 million people had diabetes. That number is projected to rise to 592 million by 2035, according to the International Diabetes Foundation (IDF). 

  • Diabetes caused 4.6 million deaths in 2011, according to the World Health Organization (WHO). It accounted for at least $465 billion in healthcare expenditures. This was approximately 11 percent of the total healthcare expenditures in adults age 20 to 79.
  • In the United States, diabetes affects 25.8 million people of all ages -- approximately 8.3% of the U.S. population, according to the American Diabetes Association (ADA). Among older U.S. residents, that percentage increases to roughly 27%.

  • Approximately 78,000 children develop Type-1 diabetes every year. 
  • Global sales of diabetes medicines totaled $35 billion in 2010 and could rise to as much as $48 billion by 2015, according to research firm IMS Health, driven by increased prevalence and treatment, especially in countries such as China, India, Mexico and Brazil.

80% in low-income countriesIn response to this healthcare crisis, biopharmaceutical companies are scrambling to bring new anti-diabetes drugs to market. But the process is complicated, due both to the increased number of people getting Type-2 diabetes, and to the increased number of drugs that will be used to treat diabetes.

Much of the interest today pertaining to research is on how anti-diabetes drugs work in special populations, such as those with renal insufficiency, patients of extreme age, and patients at high risk for major adverse cardiac events. This means researchers who once specifically excluded special populations from clinical studies, now need to adapt their approach to target these groups. They also have to comply with FDA draft guidance, released in December, 2008, mandating that new anti-diabetes drugs prove they do not increase adverse outcomes in Major Adverse Cardiovascular Events (MACE). 

This has dramatically increased the number of patients required in Phase III efficacy trials.

The last diabetes drug approved before this guidance document was Januvia, or sitagliptin, which had approximately four efficacy trials in their Phase III program with roughly 1,400 patients. In comparison Invokana, which was approved in 2013, had nine Phase III trials, with 4500 patients – three times the number of patients in the Januvia trials. Three of these nine trials included patients of special populations, including patients with chronic renal insufficiencies, an elderly patient study, and a study with patients who are at high risk for adverse cardiovascular outcomes. 

Recruiting patients for larger trials in an already crowded marketplace, is one of the many obstacles companies face in pursuing these new products. The good news is that in 2013 and beyond, we will have more options than ever in choosing the right drug for the right patient. Whether it’s a new basal-acting insulin, an extremely rapid-acting insulin, or a new oral agent that has very low adverse event, the future is very bright and the drugs that we have to choose from will deliver real benefit for patients in the years ahead.