A diabetes diagnosis may not strike fear into patients like hearing the word "cancer," but it is nonetheless a serious and chronic long-term disease that can lead to a number of worrisome complications. The American Diabetes Association lists skin and eye problems, as well as nerve damage known as neuropathy, as the primary complications associated with diabetes, although other serious complications are also mentioned, including high blood pressure and increased risk of stroke or kidney disease.
Diabetes prevalence is growing
Within the United States, per the Centers for Disease Control and Prevention, 29.1 million people have diabetes, with some 8 million of those people undiagnosed. Furthermore, another 86 million people have prediabetes and are likely to develop diabetes if their lifestyle habits don't change.
To be abundantly clear, diabetes comes in two forms. Type 1 diabetes occurs when the cells responsible for producing insulin are destroyed by the body's immune system due to a genetic malfunction. It's a non-preventable form of diabetes and it's something 5%-10% of all diabetics are born with. Type 2 diabetes, which makes up the other 90%-95% of all diagnoses, can develop at any age and is a function of the body not understanding how to properly use insulin. In general, type 2 diabetes can be prevented, or disease progression slowed, as long as the patient maintains a healthy lifestyle.
Commonly, diabetes is treated with prescription medicines designed to help diabetics control their glycemic balance. Over the past decade we've witnessed more than two dozen diabetes medications approved by the Food and Drug Administration strictly for blood sugar control. Perhaps none is better known for type 2 diabetics than Merck's Januvia. As a DPP-4 inhibitor, Januvia's job is to slow the removal of an enzyme known as DPP-4 from your body, which helps trigger the release of insulin and ultimately lowers your blood sugar.
But, could these same medicines designed to help diabetics control their disease also be harming them?
Diabetics may now have this to worry about
That was the question posed by researchers at Yale and in San Francisco this past week. The seven researchers involved in the study detailed in an abstract published in JAMA Internal Medicine that treating older diabetic patients with prescription drugs may be doing them more harm than good.
The study examined 1,288 older adults broken down into three representative groups: healthy Americans, Americans with intermediate health conditions, and those in poor health. The findings showed that despite diabetic patients presenting a gambit of good health to poor health, the treatment for the disease was the same across all groups. This led researchers, based on a measurement known as A1C levels, to suggest that roughly 60% of all three groups were using blood sugar medicines designed to keep their sugar levels in a very tight range – a range that was so low in many instances that researchers believe it can lead to bouts of hypoglycemia and potential hospitalization.
Another study also released in 2014 via JAMA Internal Medicine seems to corroborate the Yale and San Francisco researchers' conclusion. The 10-author team that led the 2014 study on hospital admissions between 1999 and 2011 discovered that hospitalizations for older adults aged 65 and up from hypoglycemia (low blood sugar) outpaced those of hyperglycemia. During this 12-year period, admission rates for hypoglycemia rose from 94 persons per 100,000 to 105 per 100,000.
Is this the solution?
Obviously there are other factors that need examination here, including how those under the age of 65 respond to regular use of diabetic medications. Older adults are expected to have weaker immune systems, so there's certainly the possibility that this could be skewing the results a bit.
However, that doesn't change the fact that better medications are needed to help diabetics of all ages control their disease. In addition to leading a healthy lifestyle, I'd suggest that perhaps the answer lies in a handful of newly approved and developing therapies, as well as new insulin-regulating devices.
Personally I have my eye on three therapies recently approved by the Food and Drug Administration as two experimental therapies which could offer diabetic patients better glycemic control and flexibility.
MannKind (NASDAQ:56400P706), for example, had its inhaled insulin therapy Afrezza approved last summer. Afrezza works for type 1 and 2 diabetes and it's rapid-acting -- meaning it's more convenient for the patient. It still hasn't been launched by partner Sanofi yet so its success is still very much up in the air, however it could have a beneficial effect on patient convenience.
SGLT2 inhibitors like Johnson & Johnson's (NYSE:JNJ) Invokana and AstraZeneca's (NYSE:AZN) Farxiga could also work wonders. Instead of working in the liver or pancreas these SGLT2 inhibitors work on type 2 diabetes patients by blocking glucose absorption in the kidneys. Patients can then rid the excess glucose from their body through their urine. An advantage noted in clinical trials for SGLT2 inhibitors was their penchant for causing weight-loss in patients taking the drug. In all fairness though, it remains to be seen if SGLT2 inhibitors don't lead to the same hypoglycemia problems witnessed in the aforementioned studies.
I'd also keep your eyes peeled for experimental therapies like GW Pharmaceuticals' (NASDAQ:GWPH) GWP42004 or privately held Perie Biosciences' PRL001.
GW Pharma's drug GWP42004 is derived from cannabinoids from the cannabis plant and in phase 2a studies met its primary endpoint of a statistically significant reduction in fasting plasma glucose levels. Of course, marijuana is a touchy subject among the medical community so we'll have to wait and see if this experimental therapy pans out in broader studies.
Perie Biosciences, as Foolish biotech expert Brian Orelli recenty noted, is preparing to start late-stage testing on PRL001, a potential cure for diabetes. PRL001 is a two-drug cocktail designed to promote the regeneration of the cells that produce insulin while also protecting those cells from a person's immune system which is intent on destroying those cells due to a mutation. The primary endpoint of the study will be insulin independence, which is essentially a cure.
Don't forget this revolutionary device
I'd also suggest devices like Medtronic's (NYSE:MDT) MiniMed 530G will play an increasingly important role moving forward. Admittedly, glucose monitoring devices are often only used in patients who are more predisposed to comorbidities, but the use of diagnostic devices to personalize and enhance our lives is only growing.
The MiniMed 530G is essentially the first artificial pancreas system for diabetics. It injects insulin into the body on an as-needed basis and uses a sensor that'll shut the device off for two hours if a person's blood sugar drops too low. It's a big improvement in patient convenience, and, more importantly, it should dramatically reduce instances of hypoglycemia. This isn't to say everyone is going to be thrilled with the idea of utilizing an attached insulin device, but the intent is to demonstrate that technology in this space is advancing to the point where diabetes treatment-related hypoglycemia will hopefully soon be a thing of the past.
Clearly there's much left to be done with diabetes diagnoses on the rise and both the disease and apparent overtreatment of the disease causing room for concern. However, we are seeing ample evidence of baby steps in the right direction with treatment options and medical devices demonstrating improvement in glycemic control and patient convenience. I look forward to continued discoveries in diabetic research and only hope that we do find a cure to this disease during my lifetime.