Newer Insulin Therapy Options Broaden Treatment

More than 29 million people in the United States have diabetes. The CDC estimates that if the trend continues, 1 in 3 US residents will have the disease by 2050.

As the prevalence of diabetes grows, so does the number of insulin products on the market. At the recent AMCP Managed Care & Specialty Pharmacy Annual Meeting, several experts discussed new and emerging insulin products for diabetes management during a satellite symposium.
 

New Agents for Insulin Therapy

New agents in insulin therapy aim to enhance efficacy, safety, and patient convenience, said Amy M. Lugo, PharmD, BCPS, BC-ADM, FAPhA, clinical pharmacy specialist and director, managed care residency, Defense Health Agency, Pharmacy Operations Division Formulary Management Branch, San Antonio.

Yet not all new insulins will automatically meet with success. For example, the inhaled human insulin Afrezza received US FDA approval as a rapid-acting (bolus) insulin for adults less than 2 years ago, Dr Lugo reported, but earlier this year, makers Sanofi and MannKind Corporation announced they had terminated their partnership on the product amid low sales.

For other agents that received recent approval for insulin therapy, the book is still out on their success.

 In 2015, the class of long-acting (basal) human insulin analogs grew to include U-300 insulin glargine (Toujeo), insulin degludec (Tresiba), and U-100 insulin glargine (Basaglar) prefilled pens. The first long- and rapid-acting human insulin combination, insulin degludec/insulin aspart (Ryzodeg 70/30), received FDA approval last fall.

Dr Lugo reviewed their performance so far in clinical studies. U-300 insulin glargine has demonstrated noninferiority to U-100 insulin glargine in trials, she said, but researchers have noted a tendency toward less hypoglycemia with U-300. Because confusion with U-100 is possible, however, dosing errors are a concern.

“Despite a longer duration of action and potential benefit on nocturnal hypoglycemia, degludec’s role in therapy remains unclear,” Dr Lugo continued. “At this time, degludec offers patients another basal insulin option.”

For improvement of glycemic control, combination degludec/aspart has demonstrated noninferiority to insulins detemir, glargine, and biphasic aspart. Studies have found no difference in the total daily dose of insulin for degludec/aspart compared with the other drugs.

Basaglar—approved via the 505(b)(2) pathway for similar biologic versions of already approved reference drugs—has demonstrated noninferiority to Lantus (insulin glargine injection) in reducing A1c in type 1 and type 2 diabetes, according to the presentation. Approved in December 2015, Basaglar is expected to launch later this year.

All in all, the recently approved insulins have demonstrated noninferiority to their older insulin counterparts, Dr Lugo explained, and provide more options for patients and providers.

“When compared head-to-head, there are no compelling clinical advantages of one insulin formulation over another,” Dr Lugo said. “Other factors related to patient convenience and cost will likely guide formulary decisions.”

 Looking to the future, biosimilar insulin agents will enhance competition in the marketplace and will likely save costs over the long run, she predicted.

Insulin Use in Clinical Practice

Sarah Kim, MD, assistant clinical professor, division of endocrinology, diabetes and metabolism, University of San Francisco School of Medicine, rounded out the presentation with a discussion about insulin use in clinical practice.

Intensive glucose control, she explained, significantly decreases diabetes complications. Patients with type 1 diabetes typically require insulin, as do patients with type 2 diabetes who are not meeting glycemic goals on noninsulin medications. For most adults, glycemic goals consist of a fasting glucose between 70 mg/dL and 130 mg/dL, peak postprandial glucose less than 180 mg/dL, and HbA1c less than 7%.

Although patients with type 1 diabetes start on basal and bolus insulin immediately, patients with mild type 2 diabetes begin with noninsulin agents. When patients reach moderate insulin deficiency, they add basal insulin. Basal and bolus insulin is used when insulin deficiency is severe.

Basal insulin therapies have similar efficacies, according to the presentation. NPH [neutral protamine gagedorn] insulin is less preferable for type 1 diabetes due to a higher risk of hypoglycemia. For type 2 diabetes, only modest differences in nocturnal hypoglycemia exist among the various basal insulins.  

Bolus insulin analogs may slightly improve glycemic control in type 1 diabetes. Rapid acting insulin analogs offer no clinical benefit over regular insulin for type 2 diabetes, Dr Kim explained.

“When choosing a bolus insulin, I prefer whatever is covered in pen form by insurance,” Dr Kim said, referencing better patient adherence and more accurate dosing.

The Most Cost-Effective Route of All

According to Dr Kim, diabetes doubles the risk of heart disease and stroke. Prevention, she said, is the most cost-effective care strategy of all. “Greater than 90% of all diabetes in the US is type 2,” she said. “Type 2 diabetes can be prevented or delayed through programs that cost the same as a month’s worth of insulin.”

This program was provided by the Academy of Managed Care Pharmacy and PRIME Education, Inc and supported by an independent educational grant from Novo Nordisk.