Peptide education
Albiglutide
Tanzeum
Albiglutide is a GLP-1 receptor agonist that was sold as Tanzeum for adults with type 2 diabetes. It was injected once weekly. FDA lists both Tanzeum strengths as discontinued.
Albiglutide has substantial diabetes and cardiovascular trial evidence, but the Tanzeum presentations are discontinued in the United States.
Overview
Quick answer
The historical Tanzeum label covered glucose control. The later Harmony Outcomes trial measured cardiovascular events in adults who already had cardiovascular disease; that trial result is not a Tanzeum label indication.
What was Tanzeum used for?
Its US label described use with diet and exercise to improve blood glucose control in adults with type 2 diabetes. It was not labeled for type 1 diabetes or diabetic ketoacidosis.
How was it given?
The historical label started at 30 mg once weekly under the skin, with an increase to 50 mg when more glucose control was needed. Its single-dose pen contained powder that had to be mixed before injection.
What did Harmony Outcomes find?
Among adults with type 2 diabetes and cardiovascular disease, a composite of cardiovascular death, heart attack, or stroke occurred in 7% of the albiglutide group and 9% of the placebo group over a median follow-up of 1.6 years.
Is Tanzeum still marketed in the United States?
FDA lists both the 30 mg and 50 mg presentations as discontinued.
Evidence
Evidence snapshot
The label described once-weekly treatment for adult glucose control alongside diet and exercise.
The primary event composite was lower with albiglutide than with placebo in adults with type 2 diabetes and cardiovascular disease.
FDA lists both US Tanzeum presentations as discontinued.
Albiglutide could not be assessed for carcinogenicity in rodents; other GLP-1 receptor agonists produced rodent thyroid C-cell tumors.
Claims
Common claims vs evidence
| Claim | Human evidence | Verdict |
|---|---|---|
| Albiglutide lowered cardiovascular event risk in its outcomes trial. | The randomized trial enrolled 9,463 adults with type 2 diabetes and cardiovascular disease. Its primary composite occurred in 338 of 4,731 participants receiving albiglutide and 428 of 4,732 receiving placebo. | Supported for the trial's composite outcome and population. |
| Tanzeum was labeled for cardiovascular risk reduction. | The historical prescribing information addressed glucose control and preceded the published Harmony Outcomes result. | The trial finding and the historical label indication are different. |
| The thyroid warning means albiglutide caused thyroid tumors in rodents. | The label states that albiglutide's carcinogenicity could not be assessed in rodents. The warning refers to tumors seen with other GLP-1 receptor agonists. | Human relevance and albiglutide's thyroid tumor risk remain unknown. |
Bottom line
Main takeaway
Tanzeum was a weekly diabetes injection; its two US presentations are discontinued.
Harmony Outcomes measured cardiovascular death, heart attack, and stroke in people with type 2 diabetes and cardiovascular disease.
The historical product label focused on glycemic control; the later trial evaluated a cardiovascular composite.
Identity
What it is
Albiglutide joins a GLP-1 analog to human albumin, extending its activity enough for weekly administration. GLP-1 receptor activity helps the pancreas release insulin when glucose is elevated and slows gastric emptying.
Tanzeum was supplied in a single-dose pen with a powder and diluent. FDA now lists both marketed strengths as discontinued.
Use context
Routes, doses, and cycle patterns
The historical diabetes label and Harmony Outcomes both used weekly subcutaneous injections. Tanzeum is no longer listed as a marketed US product.
Human studies and product labels
Tanzeum historical adult label
- Purpose
- Glycemic control in type 2 diabetes
- Context
- Historical US product label
- Route
- Subcutaneous injection
- Amount
- 30 mg weekly initially; 50 mg weekly if additional glucose control was needed
- Frequency
- Once weekly, with or without meals
- Duration
- Ongoing diabetes treatment
The single-dose pen required reconstitution. FDA lists both strengths as discontinued.
Harmony Outcomes
- Purpose
- Cardiovascular events in type 2 diabetes with cardiovascular disease
- Context
- Randomized trial
- Route
- Subcutaneous injection
- Amount
- 30 mg weekly, with a possible increase to 50 mg; placebo was the comparator
- Frequency
- Once weekly with standard care
- Duration
- Median follow-up of 1.6 years
The trial enrolled adults aged 40 or older and evaluated a composite of cardiovascular death, heart attack, or stroke.
Research
Research evidence
The diabetes label and the cardiovascular trial address different questions. Harmony Outcomes enrolled adults with type 2 diabetes and existing cardiovascular disease and found fewer primary composite events with albiglutide than with placebo.
| Study / evidence area | Population | Design | Product context | Main outcome | Limitations | Weight |
|---|---|---|---|---|---|---|
| Harmony Outcomes | 9,463 adults aged 40 or older with type 2 diabetes and cardiovascular disease | Randomized, double-blind, placebo-controlled trial | Weekly albiglutide or placebo with standard care | Cardiovascular death, heart attack, or stroke occurred in 7% versus 9% over a median 1.6 years. | Participants had established cardiovascular disease; the trial did not study a general weight-management population. | Strong |
| Tanzeum prescribing information | Adults with type 2 diabetes | Historical FDA product label | Discontinued weekly injection | The label described glycemic control with diet and exercise and provided a 30 mg to 50 mg weekly schedule. | The label preceded the cardiovascular outcomes trial, and FDA lists both presentations as discontinued. | Strong for the historical label |
Cautions
Safety and unknowns
- The historical label carried a boxed thyroid C-cell warning. Albiglutide could not be assessed for carcinogenicity in rodents; other drugs in its class caused thyroid C-cell tumors in rodents. The label contraindicated use with a personal or family history of medullary thyroid carcinoma or MEN2.
- Nausea, diarrhea, and injection-site reactions were among reported adverse reactions. The label also warned about pancreatitis, serious hypersensitivity, and kidney injury, including injury associated with severe digestive symptoms.
- Hypoglycemia risk increased with insulin or sulfonylureas. The historical label also cautioned about use in severe gastrointestinal disease.
Mechanism
How it is proposed to work
Albiglutide activates GLP-1 receptors, helping increase insulin release when blood glucose is elevated. It also slows stomach emptying.
The molecule combines GLP-1 analog sequences with human albumin, supporting its long duration of action.
Details
Technical details
Sources
References
- 1.
FDA. Tanzeum (albiglutide) prescribing information
Historical US label for glycemic control, dosing, reconstitution, and warnings.
- 2.
FDA. FDA Purple Book: Tanzeum product details
FDA lists both Tanzeum strengths as discontinued.
- 3.
PubMed. Albiglutide and cardiovascular outcomes in patients with type 2 diabetes and cardiovascular disease
doi:10.1016/S0140-6736(18)32261-X PMID:30291013 NCT02465515
Randomized cardiovascular outcomes trial in adults with type 2 diabetes and cardiovascular disease.
- 4.
PubMed. Harmony Outcomes: trial design and baseline characteristics
PMID:30015066
Primary trial design specifies the initial weekly dose and possible increase.