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Albiglutide

GLP-1 agonist · type 2 diabetes

Albiglutide is a long-acting GLP-1 receptor agonist made by fusing two copies of a modified GLP-1 peptide to human albumin. It was approved in the US as Tanzeum to help control blood sugar in adults with type 2 diabetes, but it is no longer marketed.

Class
GLP-1 receptor agonist
Approval status
Was FDA-approvedApproved as Tanzeum (2014); now discontinued
Body systems
Metabolism & weightHeart & vessels

How it works

GLP-1 is a gut hormone released after meals. Acting on GLP-1 receptors, it increases insulin release when blood glucose is high and slows stomach emptying, and the FDA label describes both effects for albiglutide1. Natural GLP-1 is quickly broken down by the enzyme DPP-4.

In albiglutide, the alanine at position 8 of each GLP-1 copy is replaced with glycine to resist DPP-4, and the attached albumin protein slows clearance, giving a half-life of about five days1. Because the molecule is a large fusion protein, it was produced in genetically modified yeast rather than built by chemical synthesis1.

What the research shows

Albiglutide was studied in the HARMONY phase 3 program. In HARMONY 7, an open-label head-to-head trial in 841 adults with type 2 diabetes, HbA1c fell 0.78 percentage points over 32 weeks with albiglutide versus 0.99 with liraglutide, so non-inferiority was not shown; albiglutide caused more injection-site reactions but fewer gastrointestinal events2. The HARMONY Outcomes trial randomized 9,463 people aged 40 or older with type 2 diabetes and cardiovascular disease to albiglutide or placebo on top of usual care. Over a median 1.6 years, heart attack, stroke or cardiovascular death occurred in 7% versus 9% (hazard ratio 0.78), meeting the test for superiority over placebo; rates of pancreatitis and pancreatic cancer did not differ meaningfully between groups, and no medullary thyroid cancer was seen3.

Approval

The FDA approved albiglutide (Tanzeum, GlaxoSmithKline) in 2014 as an add-on to diet and exercise for blood sugar control in adults with type 2 diabetes. Its US listing is now marked discontinued, so it is no longer available4.

Side effects & cautions

In the label, reactions seen in at least 5% of users and more often than with placebo were upper respiratory infection, diarrhea, nausea, injection-site reactions, cough, back pain, joint pain, sinusitis and flu. A boxed warning covered thyroid C-cell tumors, which other GLP-1 drugs caused in rodents; the label also warned about pancreatitis, low blood sugar when combined with insulin or sulfonylureas, serious allergic reactions, and acute kidney injury1.

References

  1. FDA label: Tanzeum (2017)FDA
  2. Pratley et al., Lancet Diabetes Endocrinol 2014PubMed
  3. Hernandez et al., Lancet 2018PubMed
  4. Drugs@FDA: BLA 125431 (Tanzeum)FDA

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