Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Double-Blind, Active-Controlled Study to Evaluate the Durability of the Efficacy and Safety of Alogliptin Compared to Glipizide When Used in Combination With Metformin in Subjects With Type 2 Diabetes
Brief Summary: The purpose of this study is to determine the safety and effectiveness of adding alogliptin, once daily (QD), compared to glipizide with metformin in diabetic patients.


Options:
A: Inclusion Criteria:

* Males and females, age 50-75 years
* Type 2 diabetes of at least 2 years duration
* BMI 20-45 Kg/m2
* Stable treatment for the last two months with metformin in monotherapy (at least 2 gr/die)
* HbA1c \>=7.0% and \<=9.0%

Exclusion Criteria:

* Type 1 diabetes
* Previous treatment with thiazolidinediones in the last six months
* Contraindication/intolerance to metformin or SUs or TZDs
* Documented coronary or cerebrovascular events in the previous 3 months
* Serum creatinine \> 1.5 mg/dl
* History of congestive heart failure, NYHA I or higher
* Chronic use of glucocorticoids
* Ischemic ulcer or gangrene
* Liver cirrhosis or severe hepatic dysfunction (ALT increase of 2.5 times the upper normal limit)
* Pregnancy or breast feeding
* Cancer, substance abuse, or any health problem that may interfere with the compliance to the study protocol or limit life expectancy
B: Inclusion Criteria:

* Has a diagnosis of type 2 diabetes mellitus.
* Must meet one of the following:

  * Has been inadequately controlled on a stable daily dose of ≥1500 mg (or documented maximum tolerated dose) of metformin for at least 2 months prior to Screening.
  * Has been inadequately controlled (as defined by a glycosylated hemoglobin 7.5 - 10%, inclusive) on metformin \<1500 mg without documented maximum tolerated dose.
* No treatment with antidiabetic agents other than metformin within 2 months prior to Screening (for Schedule A)/Pre-Screening (for Schedule B).
* Has body mass index within 23 kg/m\^2 and 45 kg/m\^2 unless the patient is Asian or of Asian descent, for whom the allowable body mass index will be ≥ 20 kg/m\^2 and ≤ 35 kg/m\^2, inclusive.
* Has fasting C-peptide concentration at least 0.8 ng.
* If regularly using non-excluded medications, must be on a stable dose at least 4 weeks prior to Screening/Pre-screening.
* Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant, lactating or intends to donate ova from Screening throughout the duration of the study.
* Must be able and willing to monitor their blood glucose concentrations with a home monitor, and comply with protocol requirements including scheduled clinic appointments.

Exclusion Criteria:

* Systolic blood pressure greater than or equal to 150 mmHg and/or diastolic pressure greater than or equal to 90.
* Hemoglobin less than or equal to 12 g/dL for males and less than or equal to 10 g/dL for females at Screening Visit.
* Alanine aminotransferase greater than or equal to 2.5 times the upper limit of normal at Screening Visit.
* Serum creatinine greater than or equal to 1.5 mg/dL for males and 1.4 for females, or calculated creatinine clearance less than 60 L/min.
* Males intending to impregnate others or donate sperm before, during or within 1 month after participating in the study.
* A history of cancer other than squamous or basal cell carcinoma of the skin that has not been in full remission for at least 5 years.
* A history of laser treatment for diabetic retinopathy within 6 months of screening.
* Treated for diabetic gastric paresis, gastric banding, or gastric bypass.
* New York Heart Association Class III or IV heart failure.
* History of coronary angioplasty, coronary stent placement, coronary bypass surgery, myocardial infarction, stroke or transient ischemic attack within 3 months prior to screening.
* Known history of human immunodeficiency virus, hepatitis B or C.
* Alcohol or substance abuse within 2 years prior to screening.
* Is required to take or intends to continue taking any disallowed medication, any prescription medication, herbal treatment or over-the counter medication that may interfere with evaluation of the study medication, including:

  * Any investigational drug within 30 days
  * Any investigational diabetic drug within 3 months
  * Any antidiabetic drug in the dipeptidyl peptidase-4 inhibitors or glucagon-like peptide-1 mimetics classes within 90 days prior to Screening other than metformin
  * Prior treatment with alogliptin.
  * Weight-loss drugs
  * Oral or systemically injected glucocorticoids
* A hypersensitivity allergy or anaphylactic reaction to any dipeptidyl peptidase-4 drug, metformin or glipizide.
* Has a documented history or concurrent signs of significant thyroid disease (eg, autoimmune thyroid diseases such as Graves disease and Hashimoto thyroiditis or active thyroid nodules).
C: Inclusion criteria:

Patients between 18 and 80 years old with type 2 diabetes and insufficient glycemic control \[glycosylated hemoglobin (HbA1c 7% to 10%)\] despite therapy with a sulfonylurea drug

Exclusion criteria:

Myocardial infarction,stroke or transient ischaemic attack in last 6 months Treatment with rosiglitazone, pioglitazone, GLP-1 analogues, insulin or anti-obesity drugs in the past 3 months Impaired hepatic function Severe renal impairment Current treatment with systemic steroids Change in thyroid hormone dosage Hereditary galactose intolerance
D: Inclusion Criteria:

* All patients must have a diagnosis of T2DM and be currently treated with metformin and sulphonylurea
* Patients in the study must have a HbA1c between \>=7 and \<=10.5%
* Patients must have a fasting plasma glucose (FPG) \<270 mg/dL (15 mmol/L)

Exclusion Criteria:

* History of diabetic ketoacidosis, type 1 diabetes mellitus (T1DM), pancreas or beta cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy, or a severe hypoglycemic episode within 6 months before screening

Answer: B