Pharmacologic class: Glucagon-like peptide-1 (GLP-1) receptor agonist
Active ingredients: Albiglutide [recombinant fusion protein] 30 mg, 50 mg; per Pen; lyophilized pwd for SC inj after reconstitution; preservative-free
Indication: Adjunct to diet and exercise, to improve glycemic control in adults with type 2 diabetes. Limitations of use: not recommended as first-line treatment for patients inadequately controlled on diet and exercise. Not studied in combination with prandial insulin or with history of pancreatitis. Not for treating type 1 diabetes or diabetic ketoacidosis. Not a substitute for insulin. Not recommended in patients with pre-existing severe GI disease.
Pharmacology: Tanzeum is an agonist of the GLP-1 receptor and augments glucose-dependent insulin secretion. GLP-1 also suppresses glucagon secretion during periods of hyperglycemia and slows gastric emptying.
Clinical trials: Tanzeum was studied as monotherapy and in combination with metformin, metformin + sulfonylurea, thiazolidinedione ± metformin, and insulin glargine ± oral antidiabetics. The efficacy of Tanzeum was compared with placebo, glimepiride, pioglitazone, liraglutide, sitagliptin, insulin lispro, and insulin glargine.
Tanzeum as monotherapy was evaluated in a 52-week, randomized, double-blind, placebo-controlled, multicenter trial in patients with type 2 diabetes (n = 296). Patients were randomized to Tanzeum 30 mg SC once weekly, Tanzeum 30 mg SC once weekly uptitrated to 50 mg once weekly at week 12, or placebo.
The primary end point was the mean change in HbA1c from baseline to week 52. Results showed that Tanzeum 30 mg had a mean change in HbA1c of −0.7% (difference from placebo −0.8; [95% CI: −1.1, −0.6]) and Tanzeum 50 mg had a mean change in HbA1c of −0.9% (difference from placebo −1.0; [95% CI: −1.3, −0.8]). Compared with placebo, treatment with Tanzeum 30 mg and 50 mg resulted in statistically significant reductions in HbA1c from baseline at week 52 (P < 0.0001).
The efficacy of Tanzeum was also evaluated as combination therapy in a 104-week randomized, double-blind, multicenter trial in patients with type 2 diabetes (n = 999) inadequately controlled on background metformin therapy (≥1,500 mg daily). Patients were randomized to Tanzeum 30 mg once weekly with optional uptitration to 50 mg after minimum of 4 weeks (n = 297), placebo (n = 100), sitagliptin 100 mg daily (n = 300), or glimepiride 2 mg daily (n = 302).
Results in this trial showed the change in HbA1c for Tanzeum was −0.6% (difference from placebo −0.9; [95% CI: −1.16, −0.65], sitagliptin −0.4; [95% CI: −0.53, −0.17], and glimepiride −0.3; [95% CI: −0.45, −0.09]). Compared with placebo, sitagliptin, and glimepiride, treatment with Tanzeum resulted in significantly greater reduction in HbA1c from baseline at week 104 (P < 0.0137).
For more clinical trial data, see full labeling.
Adults: Give by SC injection in the abdomen, thigh, or upper arm on the same day each week without regard to meals. Initiate at 30 mg once weekly; may increase to 50 mg once weekly if inadequate response. Renal impairment: caution with initiating or escalating doses.
Children: <18 years: not established.
Contraindications: History (personal or family) of medullary thyroid carcinoma. Multiple endocrine neoplasia syndrome type 2.
Warnings/precautions: Inform patients of thyroid cancer risk and symptoms. Monitor for pancreatitis; discontinue if suspected; do not restart if confirmed. History of pancreatitis; consider other antidiabetic therapies. Discontinue if hypersensitivity occurs. Monitor renal function in renally impaired patients reporting severe GI reactions. Pregnancy (Category C). Nursing mothers: not recommended.
Interactions: Increased risk of hypoglycemia with concomitant sulfonylureas or insulin; consider reducing their doses. May affect absorption of other oral drugs (delayed gastric emptying).
Adverse reactions: Upper respiratory tract infection, diarrhea, nausea, injection site reaction.
How supplied: Single-dose Pen—4
For more information, call (877) 356-8368 or visit www.Tanzeum.com