Xultophy Insulin Pen (Insulin Degludec / Liraglutide)

The FDA has approved GlaxoSmithKlinea s Tanzeum (albiglutide) subcutaneous injection as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus (T2DM). The approval, however, carries with it several limitations: (1) the medication is not recommended as first-line therapy for patients inadequately controlled on diet and exercise; (2) it has not been studied in patients with a history of pancreatitis; (3) it is not for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis; (4) it is not for patients with preexisting severe gastrointestinal disease; and (5) it has not been studied in combination with prandial insulin.1 Approximately 24 million Americans and 382 million people worldwide are affected by diabetes, with up to 95% of these cases being T2DM.2,3

Pharmacology and Pharmacokinetics

Tanzeum is a glucagon-like peptide-1 (GLP-1) receptor agonist. GLP-1 is an incretin hormone that helps to reduce blood glucose levels; it is often reduced or absent in patients with T2DM.2 Tanzeum augments glucose-dependent insulin secretion and slows gastric emptying. 1 It has an elimination half-life of approximately 5 days. Age, gender, race, and body weight do not affect the pharmacokinetics of Tanzeum.1

Dosage and Administration

Tanzeum should be given subcutaneously in the abdomen, thigh, or upper arm as a 30-mg dose once weekly, and may be increased to 50 mg once weekly in patients needing additional glycemic control. The dose can be given at any time of day, without regard to meals. If a dose is missed, administer a dose within 3 days. Tanzeum is available as a 30-mg or 50-mg single-dose pen.1

Clinical Trials

The safety and efficacy of Tanzeum was evaluated in 8 clinical trials of more than 2000 patients with T2DM. It has been studied alone and in combination with metformin, metformin and a sulfonylurea, a thiazolidinedione (with and without metformin), and insulin glargine (with or without oral antidiabetic drugs).1,3 The efficacy of Tanzeum was compared with placebo, glimepiride, pioglitazone, liraglutide, sitagliptin, insulin lispro, and insulin glargine. In patients with T2DM, treatment with Tanzeum resulted in a clinically relevant reduction from baseline in glycated hemoglobin compared with placebo.