New and Emerging Innovations in T2DM Care—Strategies to Promote Treatment Adherence

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Biosimilar insulin. Basaglar is considered a “follow-on product” or biosimilar to insulin glargine because insulin glargine was approved under the federal Food, Drug, and Cosmetic Act. The term “biosimilar” is reserved for “equivalent” biological products that follow biologic agents licensed under the Public Health Service Act. In studies evaluating basaglar and insulin glargine, basaglar provided effective and comparable glucose control with similar safety profiles in patients with T2DM.

Oral GLP-1 RA. Semaglutide, a GLP-1 RA administered once weekly, is currently in development but is not yet approved for the treatment of T2DM; however, in patients with T2DM receiving semaglutide who were at high CV risk, the rate of CV death, nonfatal myocardial infarction, or nonfatal stroke was significantly lower compared with both placebo (SUSTAIN 6) and dulaglutide, another once-weekly GLP-1 RA (SUSTAIN 7). Currently, all GLP-1 RAs are available only in injectable form, but an oral form of semaglutide, with the potential for higher solubility and protection from enzymatic degradation by DPP-4, is also being developed.

Injections combining insulin and a GLP-1 RA. One injection daily delivers basal insulin plus a synthetic gut hormone (a GLP-1 RA) that decreases appetite and supports weight loss. As a result, this combination of injectable therapies has the potential to help patients reach HbA1c goals with the potential for less weight gain and hypoglycemia than seen with insulin therapy alone. Two fixed-ratio combinations have been approved: insulin glargine/lixisenatide and insulin degludec/liraglutide. Dose adjustments are made based on fasting glucose levels.

ITCA 650 (continuous subcutaneous [SC] delivery of exenatide). ITCA 650 is an osmotic mini-pump system that is placed subdermally and is designed to deliver a continuous SC release of exenatide for 6 to 12 months. Results from 4 phase 3 clinical trials (FREEDOM 1, FREEDOM-HBL, FREEDOM 2, and FREEDOM-CVO) have shown that ITCA 650 significantly reduced mean HbA1c levels in T2DM patients, including those with an initial high baseline HbA1c, with resulting weight loss when added to lifestyle changes and metformin and when compared to sitagliptin, a DPP-4 inhibitor. ITCA 650 also has met primary and secondary end points for noninferiority for CV safety, an area that continues to be evaluated.

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a Low risk of hypoglycemia when used as monotherapy.

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