Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomized, Open-label, Parallel-group, Multicenter Study to Determine the Efficacy and Long-term Safety of Albiglutide Compared With Insulin in Subjects With Type 2 Diabetes Mellitus.
Brief Summary: A study to determine the safety and efficacy of albiglutide in subjects with type 2 diabetes.


Options:
A: Inclusion Criteria:

* Type 2 diabetes
* Subjects diagnosed with type 2 diabetes and treated with one or more oral antidiabetic drugs (OADs) for the last 3 months
* HbA1c: 7.0-11.0% (both incl.) for subjects on OAD alone
* HbA1c: 7.0-10.0 % (both incl.) for subjects on OAD combination therapy
* BMI less than 45.0 kg/m\^2

Exclusion Criteria:

* Treatment with insulin within the last 3 months prior to the trial
* Impaired liver or/and renal function
* Significant cardiovascular disease over the last 6 months
* Known retinopathy or maculopathy
* Recurrent major hypoglycaemia or hypoglycaemic unawareness
B: Inclusion Criteria:

* Diagnosed with Type 2 diabetes mellitus
* On a stable dose of metformin (≥1500 mg/day) for at least 12 weeks with inadequate glycemic control
* Females of reproductive potential agree to remain abstinent or use or have their partner use acceptable methods of birth control

Exclusion Criteria:

* History of type 1 diabetes mellitus or a history of ketoacidosis
* Treated with any antihyperglycemic agents (AHA) therapies other than the protocol-required metformin within the prior 12 weeks of study participation or with omarigliptin at any time prior to signing informed consent
* On a weight loss program and is not in the maintenance phase or has

started a weight loss medication in the past 6 months or has undergone bariatric surgery within 12 months prior to study participation

* Medical history of active liver disease (other than non-alcoholic

hepatic steatosis), including chronic active hepatitis B or C, primary biliary cirrhosis, or symptomatic gallbladder disease

* Human immunodeficiency virus
* New or worsening coronary heart disease, congestive heart failure, myocardial infarction, unstable angina, coronary artery intervention, stroke or transient ischemic neurological disorder within the past 3 months
* History of malignancy ≤5 years prior to study participation except for adequately treated basal cell or squamous cell skin cancer, or in situ

cervical cancer

* Clinically important hematological disorder (such as aplastic anemia,

myeloproliferative or myelodysplastic syndromes, thrombocytopenia)

* Pregnant or breast-feeding, or is expecting to conceive or donate eggs

during the trial, including 21 days following the last dose of study drug
C: Inclusion Criteria:

* type 2 diabetes
* BMI 20-45kg/m2 inclusive

Exclusion Criteria:

* females who are pregnant, lactating or within \<6 weeks post-partum
* current symptomatic heart failure (NYHA Class III-IV)
D: Inclusion Criteria

* Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study
* Diagnosis of type 2 (non-insulin dependent) diabetes mellitus as defined by the diagnostic criteria of the American Diabetes Association and currently taking glyburide, glipizide, glimepiride, or metformin alone, or glyburide, glipizide, or glimepiride in combination with metformin
* Glycosylated hemoglobin level greater than or equal to 7.0%
* Fasting C-peptide level greater than or equal to 0.7 ng/mL.

Exclusion Criteria:

* Type 1 (insulin-dependent) diabetes mellitus.
* Prior exposure to a thiazolidinedione, except subjects who discontinued use of troglitazone in March or April of 2000, provided they were not experiencing adverse effects and were not then taking thiazolidinediones.
* Participating in another investigational study or had participated in an investigational trial within the preceding 2 months.
* History of ketoacidosis.
* The subject had significant diabetic nephropathy, defined as a serum creatinine level greater than or equal to 1.5 mg/dL for men and greater than or equal to 1.4 mg/dL for women, or urinary protein excretion greater than or equal to 2 plus as measured by the Combistix (or equivalent) method, except subjects with proteinuria are eligible if repeat testing within 2 weeks indicates the proteinuria had resolved.
* Anemia with a hemoglobin level less than12 g/dL for men and less than10 g/dL for women.
* The subject had a history of drug or alcohol abuse within the preceding 2 years.
* The subject had a diastolic blood pressure greater than100 mm Hg or a systolic blood pressure greater than180 mm Hg.
* The subject had evidence of ongoing cardiac rhythm disturbance, delayed QT waves, or second-degree atrioventricular heart block. Uncomplicated first-degree atrioventricular block was allowed.
* Significant cardiovascular disease including, but not limited to, New York Heart Association Functional (Cardiac) Classification III or IV.
* History of myocardial infarction, acute cardiovascular event, or cerebrovascular accident within the preceding 6 months.
* Previous history of cancer that was not in remission for at least 5 years before administration of the first dose of study drug. Except, basal cell or Stage I squamous cell carcinoma.
* The subject had a BMI less than 20 or greater than 48 (calculated as weight \[kg\]/height \[m2\]).
* Alanine aminotransferase level greater than or equal 2.5time the upper limit of normal or a history of liver disease, jaundice, hepatitis, or biliary tract disease (except for uncomplicated and treated gall stones by either lithotomy or cholecystectomy).
* Unwilling or unable to comply with the protocol or attend scheduled appointments.
* Unable to understand verbal and/or written English or any other language in which a certified translation of the informed consent is available.
* Evidence of acute or unstable chronic pulmonary disease or, if a chest x-ray was available, has unexplained pulmonary lesions.
* Is required to take or continues taking any disallowed medication, prescription medication, herbal treatment or over-the counter medication that may interfere with evaluation of the study medication, including:

  * Antidiabetic agents other than study drug and companion medications (metformin and insulin).
  * Weight loss agents, including pharmaceuticals and over-the-counter brands.
  * Continuous (greater than 2 weeks) steroid therapy or expected recurrent steroid therapy, including all injectable, inhaled, topical, and oral steroid formulations.
  * Niacin therapy.
* Chronic condition for which the recurrent use of glucocorticoids could be expected
* Any other serious disease or condition at screening or randomization that might have affected life expectancy or made it difficult to successfully manage and follow the subject according to the protocol.

Answer: C