Diabetes is a huge health concern in our country. More than 29 million Americans have Type 2 Diabetes Mellitus (T2DM); another 86 million adults age 20 and over have pre-diabetes. A smaller, but significant number of Americans – 1.25 million – have Type 1 Diabetes Mellitus (T1DM). Although T1DM typically occurs in children or adolescents, it can develop in adults.

According to the American Diabetes Association, the cost of managing diabetes was $327 billion in 2017, a 26 percent increase from $245 billion in 2012. California tops the states with the largest population of people with diabetes, incurring costs of $39.47 billion.

On an individual level, people with diabetes spend 2.3 times more on health care than those without the disease. Monthly costs for T1DM patients not only include insulin, which has steadily risen, but other supplies like test strips, needles, syringes, glucagon (an emergency pen) and a glucose monitor, which can add up to nearly $1,000 per month.

Treatment options for managing T1DM are limited compared to T2DM. Currently there are only two FDA-approved medications for T1DM – insulin and pramlintide, a synthetic version of the hormone amylin.

New research for Type 1 Diabetes Mellitus

In late March 2019, the FDA is scheduled to vote on an anti-diabetic pill – Zynquista – an SGLT 1 and 2 inhibitor. If approved, this would be the first FDA-approved oral medication for T1DM. In clinical studies, Zynquista reduced the amount of insulin a person needed to inject. The advisory committee that reviewed data on this medication was split on recommendation, with eight voting for approval and eight against it.

Scientific research in the pipelines for T1DM includes studying other hormones besides insulin that play a role metabolizing glucose, immunotherapy treatment, and exploring how current FDA-approved T2DM medications may help people with T1DM. Scientists are also working on developing an artificial pancreas. Some of this research looks promising; however, it will take years before any are approved and brought to market.

Clinical trial available for T1DM patients in Coachella Valley

A clinical trial currently available in the Coachella Valley is a Phase 3 study for a new rapid-acting insulin, which is biosimilar to NovoLog (generic name of aspart). The study drug, MYL1601D, is the type of insulin a patient injects prior to a meal. This study is open to adults 18-65 with T1DM.

“The difference between the study drug and NovoLog is this new medication is developed as a biosimilar, meaning that this rapid-acting insulin is made from a different microorganism or living cell than NovoLog and will differ only slightly in its structure,” said Carlos Martinez, MD, Medical Director of Palmtree Clinical Research. “A biosimilar medicine is not a generic,” he explained. “It is developed to be highly similar to the already approved biological medication and as such is expected to have a similar or better efficacy and safety profile.”

Especially with rising costs of diabetes care, clinical trials can offer great assistance to participants as they receive free study-related care and medicine during the trial. Once approved, a biosimilar can mean an increase in access to treatment for all patients and more controlled pricing as the biosimilar competes with other insulin medications on the market.

To find out more about the biosimilar insulin study and other current trials, contact Palmtree Clinical Research at (760) 778.7799 or visit www.palmtreeclinical.com.