Emerging Therapies

A number of promising oral and injectable agents for diabetes are currently in late-stage development and were featured in posters, oral abstract presentations, and symposia during the 2012 ADA annual meeting. The following is a sampling of new medications with potentially important implications for the treatment of patients with diabetes.

Data presented from a phase 2b study with empagliflozin, a sodium glucose cotransporter-2, which increases renal glucose excretion, showed reductions in hemoglobin (Hb) A1c, fasting plasma glucose (FPG), and body weight in patients with type 2 diabetes at 90 weeks. Hans-Juergen Woerle, MD, Vice President, Boehringer Ingelheim, Germany, presented this randomized, multinational, open-label extension study in a late-breaking abstract session at the 2012 ADA annual meeting.

The anti-inflammatory agent salsalate, used for decades as a treatment for rheumatoid arthritis, also has glucose-lowering properties, said Steven Shoelson, MD, PhD, Associate Director of Research at the Joslin Diabetes Center, Boston, and principal investigator of a placebo-controlled study of salsalate in patients with type 2 diabetes.

Salsalate lacks many of the side effects of aspirin; however, in the current study, this drug was associated with weight gain and an increase in low-density lipoprotein cholesterol (LDL-C), said Dr Shoelson.

Several studies related to the GetGoal Program involving the investigational glucagon-like peptide (GLP)-1 agonist lixisenatide were presented at the 2012 ADA annual meeting. Glycemic control was improved in patients with type 2 diabetes with once-daily lixisenatide added to various antidiabetes medications, including basal insulin in the GetGoal-L study, pioglitazone in the GetGoal-P study, and insulin glargine and oral agents in the GetGoal Duo 1 study.

The investigational long-acting basal insulin LY2605541 is associated with a lower rate of nocturnal hypoglycemia compared with insulin glargine, while also promoting weight loss. LY2605541 consists of insulin lispro modified with a 20-kDa polyethylene glycol moiety. The large hydrodynamic size of LY2605541 slows insulin ab­sorp­tion and reduces its clearance, resulting in a prolonged duration of action. Exposure is unaffected by renal impairment.

The investigational ultra–long-acting insulin degludec improves long-term glycemic control in patients with type 2 diabetes similar to insulin glargine but with a reduced rate of nocturnal and severe hypoglycemia, and greater weight loss, said Bernard Zinman, MD, Director of the Diabetes Center at Mount Sinai Hospital, Professor of Medicine, University of Toronto, and lead investigator of a randomized head-to-head comparison.

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