Editor’s note: In observation of World Diabetes Day on Thursday, Durham-based Quintiles (NYSE: Q) made available a video, an informational graphic and a host of other information that – collectively warning about the increasing threat posed by the disease worldwide. Affecting 366 million people worldwide, diabetes also accounts for a big percentage of healthcare costs. In 2011, the percentage was 11 percent. Dr. Erica Caveney, M.D., the Senior Director of Global Diabetes Therapeutic Strategy and head of the Cardiovascular and Metabolic Therapeutic Delivery Unit at Quintiles, appeared in a three-part video describing the diabetes threat and efforts to combat it. Quintiles is the world’s largest life science cservices provider company and is actively involved in diabetes research. The transcripts of those videos as provided by Quintiles at the request of WRALTechWire follows.
DURHAM, N.C. – Globally, diabetes is an increasingly serious problem. In 2011, approximately 366 million people had diabetes, and by 2030, this number is expected to rise to 552 million people. The number of people with type 2 diabetes has increased in every single country.
Diabetes causes approximately 4.6 million deaths in 2011, and it counts for 456 billion dollars in healthcare expenditures globally, which is approximately 11% of the total healthcare expenditures for adults ages 20 to 79.
And approximately 48,000 children develop type 1 diabetes annually. In the United States, diabetes affects 26.8 million people, or approximately 8.3% of the U.S. population. Among older U.S. residents, that percentage increases to 27%. Looking at the younger population, approximately 215,000 people ages less than 20 have both type 1 and type 2 diabetes.
Diabetes is the leading cause of kidney failure, non-traumatic lower limb amputation, and new cases of blindness in the United States, and is the seventh leading cause of death in the United States.
Also, in China, approximately 115 million Chinese adults have type 2 diabetes.
The landscape for bringing a new anti-diabetes drug to market has changed drastically in the last five to seven years. As everybody who does diabetes clinical trials is well aware, in December 2008, the FDA issued a draft guidance for mandating that new anti-diabetes drugs had to prove that they did not increase adverse outcomes in MACE, or major, in MACE events.
The last diabetes drug that was approved before these December 2008 guidance document was Januvia, or sitagliptin. And Januvia had approximately four efficacy trials in their Phase III program, one of which was 12 weeks. They had approximately 1,400 patients in these four Phase III efficacy trials.
One of the most recent diabetes drugs to be approved is Invokana. And if you take what has happened in the last seven years, from the time that Januvia was approved, to Invokana, the amount of patients in the Phase III programs have gone up approximately 5,000—by 5,000 patients.
You have—you’ve gone from four Phase III efficacy trials to nine Phase III trials. Three of these nine trials include patients of special populations, including patients with chronic renal insufficiencies, an elderly patient study, and a patient—a study with patients who are at high risk for cardio—adverse cardiovascular outcomes.
Complicated Future for Anti-Diabetes Drug
The future for bringing an anti-diabetes drug to market will continue to be complicated, and this is a fact because of the—both the increased number of people getting type 2 diabetes and also the increased number of drugs that will be used to treat the diabetes.
As the amount of type 2 diabetes drugs continues to increase to be available to providers for their patients, it will become more important than ever to match the right drug to the right patient.
And—we know that the progression of type 2 diabetes is different for everybody, and the amount of co-morbidities a patient might suffer will differ between—between patients, and so it will be more important than ever to match the right drug to the might—right patient. And luckily, the good news is that in 2013 and beyond, we have more options than ever in choosing the right drug for the right patient.
And so whether it’s a new insulin, whether it’s basal-acting insulin or a new super rapid-acting insulin that can help benefit patients with type 1 diabetes, or those with type 2 diabetes that are very late in their disease, or a new oral agent that is—has very low adverse event—effects and maybe works on different pathways of the metabolic syndrome other than just treating the disregulation of glucose metabolism, the future is very bright and the drugs that we have to choose from will be—a real benefit for the patients in the upcoming years.
The good news for patients that have diabetes is there are more compounds being tested than ever in diabetes. We’ve had a record number of drugs being approved in the last few years, but we also have some very exciting new compounds in various stages of development. We know that diabetes is a very heterogeneous disease. We have both type 1 and type 2 diabetes, and then within type 2 diabetes, the—the pathway that the patient goes down, the evolution of the diabetes varies differently.
So we treat diabetes in the beginning with diet and exercise, and then in late-stage diabetes it is treated with insulin. And there are a lot of steps in between.
So matching the right drug for the right patient really is an art and a science, and luckily for all the patients who are suffering with diabetes, this is—in the last hundred years of diabetes research, this is the time where we can help patients the most.
What this means for clinical trials is that it is more important than ever to be sure that you match the right patient in your entrance criteria with the drug. In other words, you want to make sure that you are enrolling the patient that is going to benefit most from your diabetes drug.
So— even though the diabetes disease is a very heterogeneous and progressive disease, it is more important than ever to ensure that we match up the right patient for your clinical trial to ensure you get the most efficacious—to ensure that you get data that provides you with the answers that you’re looking for.
The Future Is Brighter Than Ever
The future for patients with diabetes has never been brighter. Both patients with type 1 and type 2 diabetes can expect to really benefit from today’s ongoing research and development with new anti-diabetes studies. So the—as the research and development pipeline for diabetes is very crowded, it is more important than ever that we match up the correct patients with the correct clinical trials.
As we know that the patient who has been newly diagnosed, and may be medication-naïve in type 2 diabetes, varies differently, pathophysiologically, from somebody who is late in their—late in their disease with type 2 diabetes, it’s very important that we match the right patient to the right clinical trial.
The benefits of this will be the patients and the providers, when these drugs are approved, and they really know which patients will benefit from which drugs
The patients will really be the ones who benefit from this crowded research and development pipeline because they will really be able to take the correct drug for them, at the correct stage of their diabetes.