General Information

Tanzeum (albiglutide) is an agonist of the albumin-based glucagon-like peptide (GLP)-1 fusion protein. It augments glucose-dependent insulin secretion and slows gastric emptying.

Tanzeum is specifically indicated as an adjunct to diet and exercise to improve glycemic control in adults with type II diabetes mellitus.

Mechanism of Action

Tanzeum (albiglutide) is a GLP-1 receptor agonist, a recombinant fusion protein comprised of 2 tandem copies of modified human GLP-1 genetically fused in tandem to human albumin. The human GLP-1 fragment sequence 7 36 has been modified with a glycine substituted for the naturally-occurring alanine at position 8 in order to confer resistance to dipeptidylpeptidase IV (DPP-IV) mediated proteolysis. The human albumin moiety of the recombinant fusion protein, together with the DPP-IV resistance, extends the half-life allowing once-weekly dosing.

Side Effects

Adverse effects associated with the use of Tanzeum may include, but are not limited to, the following:

Upper respiratory tract infection

Diarrhea

Nausea

Injection site reaction

Dosing/Administration

Tanzeum is supplied as a solution for subcutaneous injection. The recommended dose is 30 mg once weekly given as a subcutaneous injection in the abdomen, thigh or upper arm region. The dosage may be increased to 50 mg once weekly if the glycemic response is inadequate. Tanzeum may be administered at any time of day without regard to meals. It should be administered once a week on the same day each week. The day of weekly administration may be changed, if necessary, as long as the last dose was administered four or more days before. If a dose is missed, Tanzeum should be administered as soon as possible within three days after the missed dose. Thereafter, dosing can resume on the usual day of administration. If it is more than three days after the missed dose, dosing should wait until the next regularly scheduled weekly dose.

Clinical Trial Results

FDA Approval
The FDA approval of Tanzeum was based on a 52-week, randomized, double-blind, placebo-controlled, multicenter trial. A total of 296 subjects with type II diabetes inadequately controlled on diet and exercise were randomized Tanzeum 30 mg SC once weekly, Tanzeum 30 mg SC once weekly uptitrated to 50 mg once weekly at week 12, or placebo. Compared with placebo, treatment with Tanzeum 30 mg or 50 mg resulted in statistically significant reductions in HbA1c from baseline at week 52. The adjusted mean change in weight from baseline did not differ significantly between Tanzeum (-0.4 to -0.9 kg) and placebo (-0.7 kg) at week 52.