Clinical trial NCT02683746 (phase 3, status: completed)
Conditions: diabetes mellitus, type 2
ICD codes: E11.65, E11.9, E11.21, E11.36, E11.41, E11.42, E11.44
Drugs: lyophilized albiglutide dcc pen injector, lyophilized albiglutide dcc pen injector matching placebo, albiglutide liquid auto-injector, albiglutide liquid auto-injector matching placebo
SMILES: CCC1=CN=C(CCOC2=CC=C(CC3SC(=O)NC3=O)C=C2)C=C1, CCC1=CN=C(CCOC2=CC=C(CC3SC(=O)NC3=O)C=C2)C=C1, CCC1=CN=C(CCOC2=CC=C(CC3SC(=O)NC3=O)C=C2)C=C1, CCC1=CN=C(CCOC2=CC=C(CC3SC(=O)NC3=O)C=C2)C=C1
Eligibility criteria:

        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).