Safety and Efficacy Study of Albiglutide Liquid Drug Product in Type 2 Diabetes Mellitus

This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring Pharmacodynamics, Safety, Albiglutide, Tolerability, Type 2 Diabetes Mellitus, Efficacy Read More

Inclusion Criteria:

• 18 to 80 years of age inclusive
• Historical diagnosis of type 2 diabetes mellitus (T2DM) (at least 3 months), experiencing inadequate glycemic control on current regimen of diet and exercise or on a stable maximal tolerated dose of metformin, maintained for approximately 8 weeks prior to screening.
• HbA1c >=7.0 percent (%) and <=10%.
• Hemoglobin >=11 grams per deciliter (g/dL) (>=110 grams per liter [g/L]) for males and >=10 g/dL (>=100 g/L) for females.
• Body mass index <=40 kilograms per squared meter (kg/m^2)
• Male or female
• Able and willing to provide informed consent.

Exclusion Criteria:

• Type 1 diabetes mellitus
• History of cancer that has not been in full remission for at least 3 years before screening. (A history of squamous cell or basal cell carcinoma of the skin or treated cervical intra-epithelial neoplasia I or II is allowed).
• Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2.
• History of acute or chronic pancreatitis.
• History of thyroid dysfunction or an abnormal (i.e., outside the normal reference range) thyroid function test assessed by thyroid stimulating hormone at screening.
• Severe gastroparesis, i.e., requiring regular therapy within 6 months before screening.
• History of significant gastrointestinal (GI) surgery that in the opinion of the investigator is likely to significantly affect upper GI or pancreatic function
• History of severe hypoglycemia unawareness
• Diabetic complications or any other clinically significant abnormality .
• Clinically significant Cardiovascular (CV) and/or cerebrovascular disease within 3 months before screening
• QT interval corrected for heart rate according to Fridericia's formula (QTcF) > 470 milliseconds (msec).
• ALT >2.5x upper limit of the normal range (ULN) or bilirubin >1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
• Current active liver or biliary disease (with the exception of Gilbert's syndrome or asymptomatic gallstones or otherwise stable chronic liver disease per investigator assessment).
• Estimated glomerular filtration rate (eGFR) <=30 milliliter (mL)/minute (min)/1.73 squared meter (m^2) (calculated using the Modification of Diet in Renal Disease [MDRD] formula) at screening.
• Fasting triglyceride level >750 milligrams per deciliter (mg/dL) at screening.
• Hemoglobinopathy that may affect proper interpretation of HbA1c.
• Medical or psychiatric disorders that would preclude effective participation in study.
• Use of oral or systemically injected glucocorticoids within the 3 months before randomization or high likelihood of a requirement for prolonged treatment (>1 week) in the 6 months following randomization.
• Use of dipeptidyl peptidase-IV inhibitors within the 3 months before randomization.
• History of alcohol or substance abuse within one year before screening.
• Known allergy to albiglutide or any product components (including yeast and human albumin), any other glucagon-like peptide-1 (GLP-1) analogue, or other study medication's excipients OR other contraindications (per the prescribing information) for the use of potential study medications.
• A positive pre-study drug/alcohol screen.
• A positive test for human immunodeficiency virus (HIV) antibody.
• The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).