WARNING: RISK OF THYROID C-CELL TUMORS
Thyroid C-cell tumors have been observed in rodent studies with glucagon-like peptide-1 (GLP-1) receptor agonists at clinically relevant exposures. It is unknown whether TANZEUM™ causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans [see Warnings and Precautions].
TANZEUM is contraindicated in patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Routine serum calcitonin or thyroid ultrasound monitoring is of uncertain value in patients treated with TANZEUM. Patients should be counseled regarding the risk and symptoms of thyroid tumors [see Contraindications Warnings and Precautions].
TANZEUM 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.
TANZEUM is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus [see Clinical Studies].
Limitations of Use:
TANZEUM is not recommended as first-line therapy for patients inadequately controlled on diet and exercise [see Warnings and Precautions].
TANZEUM has not been studied in patients with a history of pancreatitis [see Warnings and Precautions]. Consider other antidiabetic therapies in patients with a history of pancreatitis.
TANZEUM is not indicated in the treatment of patients with type 1 diabetes mellitus or for the treatment of patients with diabetic ketoacidosis. TANZEUM is not a substitute for insulin in these patients.
TANZEUM has not been studied in patients with severe gastrointestinal disease, including severe gastroparesis. The use of TANZEUM is not recommended in patients with pre-existing severe gastrointestinal disease [see Adverse Reactions].
TANZEUM has not been studied in combination with prandial insulin.
Published Studies Related to Tanzeum (Albiglutide)
Effect of renal impairment on the pharmacokinetics, efficacy, and safety of
efficacy, and safety of albiglutide in single- and multiple-dose studies... CONCLUSION: The PK, efficacy, and safety data indicate that albiglutide has a
Safety, tolerability, pharmacokinetics and pharmacodynamics of albiglutide, a
long-acting GLP-1-receptor agonist, in Japanese subjects with type 2 diabetes
CONCLUSIONS: Weekly and biweekly albiglutide improved glycemic control and were
Potential of albiglutide, a long-acting GLP-1 receptor agonist, in type 2
diabetes: a randomized controlled trial exploring weekly, biweekly, and monthly
CONCLUSIONS: Weekly albiglutide administration significantly improved glycemic
Pharmacodynamics, pharmacokinetics, safety, and tolerability of albiglutide, a
long-acting glucagon-like peptide-1 mimetic, in patients with type 2 diabetes. 
subjects... CONCLUSIONS: Albiglutide improved fasting plasma glucose and postprandial glucose
Clinical Trials Related to Tanzeum (Albiglutide)
Pharmacokinetics/Pharmacodynamics of Albiglutide [Completed]
The first part of the study includes a single dose treatment period to evaluate the
pharmacokinetic bioequivalence of a subcutaneous injection of albiglutide from process 2
drug substance compared with process 3 drug substance. The second part of the treatment
period will evaluate additional pharmacokinetic and pharmacodynamic parameters and safety
and tolerability of repeat doses of albiglutide given weekly for 12 weeks from process 2
drug substance compared with process 3 drug substance. Subjects with type 2 diabetes whose
glycemia is inadequately controlled on their current regimen of diet and exercise or stable
dose of metformin will be recruited into the study.
Dose Ranging Study of Albiglutide in Japanese Subjects [Completed]
This is a randomized, double-blind, placebo-controlled, multicenter, 4-parallel-group, dose
ranging study evaluating the dose response, efficacy and safety of subcutaneously injected
GSK716155 (albiglutide) in Japanese subjects with type 2 diabetes mellitus.
An Evaluation of the Pharmacokinetics of an Oral Contraceptive (Brevicon) When Co-administered With Albiglutide . [Completed]
This study will be an open-label study to evaluate the effect of albiglutide on the
pharmacokinetics and pharmacodynamics of a standard oral contraceptive regimen (Brevicon).
The primary objective of this study is to demonstrate the lack of effect of albiglutide
doses on the pharmacokinetics of norethindrone and ethinyl estradiol in healthy female
A Study to Determine the Long Term Safety and Efficacy of Albiglutide in Combination With Oral Monotherapy Antihyperglycemic Medications in Japanese Patients With Type 2 Diabetes Mellitus [Completed]
This study is designed to examine the long term safety and efficacy of weekly subcutaneously
injected albiglutide in combination with a single oral antidiabetic drug for 52 weeks in
Japanese subjects with type 2 diabetes mellitus.
A Drug Interaction Study of Simvastatin and Albiglutide [Completed]
This open-label study evaluates the pharmacokinetics of simvastatin when coadministered with
albiglutide in healthy adult subjects. The primary objective is to assess the effect of
albiglutide doses on the pharmacokinetics of simvastatin.
Page last updated: 2015-08-10