Another History-Making Moment for Diabetes

By Josh Bloom — Aug 23, 2015
A long-standing controversy with oral hypoglycemic drugs is that, while they lower blood glucose levels, there is little or no evidence that they add years to a patient's life. So, lower glucose levels in type 2 patients have, in effect, been little more than a controversial marker of disease. Until now.

Screen Shot 2015-08-24 at 6.10.53 AMIt has been almost a century since scientists at Eli Lilly figured out how to make large quantities of pure insulin. This historical discovery made it possible for the first time to save the lives of diabetics (mostly children). But now, we are witnessing another breakthrough.

Although perhaps not as dramatic as the development of insulin, for the first time a hypoglycemic drug has been found to increase life expectancy.

Prior to insulin in the early 20th century, the life expectancy of a child diagnosed at age 10 was about one year.

Even at that time, it was recognized that juvenile diabetes (now called insulin-dependent diabetes mellitus or IDDM, aka type 1) and the adult form (non-insulin dependent diabetes mellitus or NIDDM, aka type 2) were different diseases, even thought they both involved elevated glucose levels. Type 2 was primarily a disease that affected obese people, and could be controlled by diet. This was not the case with children.

There are other differences between two forms of the disease. Type 1 diabetics (about 10 percent of all cases) lack the ability to make insulin, and must take it, usually by injection. By contrast, the hallmark of type 2 is insulin resistance the inability of the body to use insulin. This form accounts for 90 percent of cases, and is initially treated with diet and exercise.

Since the development of NIDDM decreases life expectancy by approximately 10 years, especially from heart disease, strokes and kidney failure, when modification of lifestyle fails the standard of care has been to lower high blood glucose by use of oral hypoglycemic drugs. These only work so well, and patients who fail to control their glucose with drugs are often forced to resort to insulin, even though they already have normal or elevated level. In fact, most insulin is used by type 2 diabetics.

There are a number of classes of these drugs, which work by varying mechanisms. Most common are metformin, sulfonylureas and thiazolidinediones. Newer classes include DPP-4 inhibitors (Januvia, etc.), and sodium glucose co-transporter-2 (SGLT-2) inhibitors aka gliflozins (Jardiance).

A long-standing controversy with oral hypoglycemic drugs is that, while they lower blood glucose levels there is little or no evidence that they extend life. So, lower glucose levels in type 2 patients have, in effect, been little more than an unproven surrogate marker of disease.

Until now.

On August 20th, the results of a new study called EMPA-REG OUTCOME, were released, which looked at the effect of Jardiance a SGLT-2 inhibitor that is being co-developed by Lilly and Boehringer in more than 7,000 adults with type 2 diabetics at high risk of heart attack or stroke. When Jardiance was added to the standard of care (drugs for lowering glucose, blood pressure, and cholesterol) the combination did a better job of preventing cardiovascular deaths, heart attacks and stroke.

Hans-Juergen Woerle, Global Vice President Medicine, Boehringer Ingelheim said, The cardiovascular risk reduction Jardiance demonstrated in the EMPA-REG OUTCOME trial is exciting and we look forward to sharing the full results. Approximately 50 percent of deaths in people with type 2 diabetes worldwide are caused by cardiovascular disease. Reducing cardiovascular risk is an essential component of diabetes management.

Full study results will be presented in September at the 51st European Association for the Study of Diabetes Annual Meeting in Stockholm, Sweden.

Dr. Gil Ross, Senior Medical Director at the American Council of Science and Health said, "This news is indeed a breakthrough. While all the 'diabetes' drugs oral hypoglycemics control blood sugar levels adequately, evidence showing improved outcomes of cardiovascular disease (CVD) and neuropathy renal damage of type 2 diabetes are lacking. Indeed, some drugs have been found post facto to be detrimental. Jardiance's ability to reduce the CVD toll of type 2 diabetes the most significant in shortening life would be a major improvement and could become standard of care for newly-diagnosed diabetics."

Josh Bloom

Director of Chemical and Pharmaceutical Science

Dr. Josh Bloom, the Director of Chemical and Pharmaceutical Science, comes from the world of drug discovery, where he did research for more than 20 years. He holds a Ph.D. in chemistry.

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