Year in Review: Top Diabetes Stories of 2014
A dual-hormone bionic pancreas, turning stem cells into beta cells, and new insulin options top the list.
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MedPage Today surveyed several diabetes experts for their thoughts on the top milestones in the condition for 2014. From novel insulins to advances in the artificial pancreas, the majority said it was an exciting year for the field.
The device, developed by Edward Damiano, PhD, of Boston University, and Steven Russell, MD, PhD, of Massachusetts General Hospital, delivers both insulin and glucagon. A five-day outpatient trial -- presented at the American Diabetes Association meeting in June -- showed significant declines in plasma glucose levels without hypoglycemia concerns. The researchers have future trials planned, and hope to have the device on the market by 2017.
In September, two papers reported successful transformation of human stem cells into insulin-producing beta cells. One team was led by Douglas Melton, PhD, of Harvard, and the other by Timothy Kieffer, PhD, of the University of British Columbia. Although many questions remain unanswered, experts say these papers are a significant step forward in engineering beta cells.
In August, the FDA granted tentative approval to Eli Lilly's "biosimilar" insulin glargine. The Lantus copycat will be marketed in the U.S. as Basaglar -- as soon as the company resolves ongoing patent litigation with Lantus drugmaker Sanofi. Lantus comes off patent in February 2015. Lilly's biosimilar version is already approved in Europe. "Generics and biosimilars are welcomed as the cost of these medications is exuberant in the U.S.," said Joel Zonszein, MD, of Albert Einstein College of Medicine in New York.
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Meanwhile, the third time was the charm for MannKind's inhaled insulin, Afrezza. The FDA finally approved the drug in Juneafter two earlier denials.
Experts have expressed concerns that recent national guidelines on blood pressure and lipid management may not apply to the diabetic population. Criticisms include a lack of specific LDL cholesterol targets (along with little direction for management with drugs beyond statins), and the possibility that a blood pressure target of 130/80 may be too strict.
Tight glycemic control didn't reduce mortality or major cardiovascular events during the 10-year follow-up period of the ADVANCE study. "ADVANCE was a negative trial and, no surprise, remains negative," saidDavid Nathan, MD, of Massachusetts General Hospital. On the other hand, strict blood pressure control did diminish overall and cardiovascular death during that time.
The U.S. Preventive Services Task Force recommends that adults at risk for type 2 diabetes should be screened for elevated blood sugar levels and should be treated with lifestyle interventions if they have hyperglycemia. Patients at risk include those age 45 and older, those who are overweight or obese, and those who have a first-degree relative with the disease. Previous guidance from 2008 said there was insufficient evidence to recommend diabetes screening.
Complications of diabetes, particularly amputation and cardiovascular disease, have plummeted since the 1990s, according to an April report by the CDC. An analysis of national data found that MI rates in diabetic patients dropped 68% and amputation rates were halved over the last 20 years. But experts note that rates are still high and additional reductions are needed.
There are now three options from the newest diabetes drug class on the market: canagliflozin (Invokana), dapagliflozin (Farxiga), and empagliflozin (Jardiance). A review and meta-analysis reported at the European Association for the Study of Diabetes meeting showed that the drugs are good at controlling HbA1c while simultaneously helping patients lose weight and lower their blood pressure.
"The hope is that they will catch on as we are all trying to figure out where that class fits," said George Grunberger, MD, of the Grunberger Diabetes Institute in Michigan. "Theoretically, they can be used in anyone who has functioning kidneys. In addition to fixed-dose combinations with metformin, the race is on for a fixed-dose combination with DPP-4 inhibitors."
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