Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Determine the Efficacy and Safety of SYR110322 (SYR-322) When Used in Combination With Insulin in Subjects With Type 2 Diabetes
Brief Summary: The purpose of this study is to determine the efficacy and safety of alogliptin, once daily (QD), taken in combination with insulin for the treatment of Type 2 Diabetes.


Options:
A: Inclusion Criteria:

* Has HbA1c \>7.0% and \<=10.5%
* Has a body mass index (BMI) \>=25 kg/m2 and \<=45 kg/m2
* Has received insulin glargine for 3 months prior to study start and has been on a stable dose for 1 month prior to study start
* If taking oral antidiabetic agents, has been on a stable dose for at least 2 months

Exclusion Criteria:

* Has been previously treated with Symlin/pramlintide (or has participated in a Symlin/pramlintide clinical study)
* Has received any investigational drug within 1 month of screening
B: Inclusion criteria:

1. Diabetes type 2, detectable C-peptide, HbA1c 7-10%
2. Pretreatment with basal insulin +/- Metformin or/and +/- Pioglitazone 3 Age \> 18 years, BMI \<= 45 kg/m2

Exclusion criteria:

1. Uncontrolled hyperglycemia during Run-in
2. Myocardial infarction, stroke or TIA within 3 months prior to informed consent
3. Liver impairment; gastric surgery; medical history of cancer in last 5 years
4. Other antidiabetic drugs, antiobesity drugs, systemic steroids, other investigational drug before randomisation
5. Unsufficient birth control, pregnancy and nursing
C: Inclusion Criteria

* Diagnosis of type 2 diabetes mellitus and currently treated with insulin alone (with or without metformin), and is inadequately controlled. Metformin dose must be stable for at least 8 weeks prior to Randomization.
* No treatment with antidiabetic agents other than insulin and metformin within the 8 weeks prior to Randomization.
* Body mass index greater than or equal to 23 kg/m2 and less than or equal to 45 kg/m2
* Fasting C-peptide concentration greater than or equal to 0.8 ng per mL. (If this screening criterion is not met, the subject still qualifies if C-peptide greater than or equal to 1.5 ng per mL after a challenge test).
* Glycosylated hemoglobin concentration greater than or equal to 8.0% at Screening.
* Using a stable dose of insulin of at least 15 units but not more than 100 units per day for at least 8 weeks prior to Randomization. A dose of insulin that varies by up to 15% of the mean will be considered as stable.
* If regular use of other, non-excluded medications, must be on a stable dose for at least the 4 weeks prior to Screening. However, as needed use of prescription or over-the-counter medications is allowed at the discretion of the investigator.
* Systolic blood pressure less than or equal to180 mm Hg and diastolic pressure less than or equal to 110 mm Hg
* Hemoglobin greater than or equal to 12 g per dL for males and greater than or equal to10 g per dL for females.
* Alanine aminotransferase less than or equal to 3 times the upper limit of normal.
* Serum creatinine less than or equal to 2.0 mg per dL.
* Thyroid-stimulating hormone level less than or equal to the upper limit of the normal range and the subject is clinically euthyroid.
* Neither pregnant (confirmed by laboratory testing in females of childbearing potential) nor lactating.
* Female subjects of childbearing potential must be practicing adequate contraception. Adequate contraception must be practiced for the duration of participation in the study.
* Able and willing to monitor own blood glucose concentrations with a home glucose monitor
* No major illness or debility that in the investigator's opinion prohibits the individual from completing the study
* Able and willing to provide written informed consent

Exclusion Criteria

* Urine albumin to creatinine ratio of greater than 1000 μg per mg at Screening. If elevated, the subject may be rescreened within 1 week.
* History of cancer, other than squamous cell or basal cell carcinoma of the skin, that has not been in full remission for at least 5 years prior to Screening. (History of treated cervical intraepithelial neoplasia I or cervical intraepithelial neoplasia II is allowed.).
* History of laser treatment for proliferative diabetic retinopathy within the 6 months prior to Screening.
* History of treated diabetic gastric paresis.
* New York Heart Association Class III or IV heart failure regardless of therapy. Currently treated subjects who are stable at Class I or II are candidates for the study.
* History of coronary angioplasty, coronary stent placement, coronary bypass surgery, or myocardial infarction within the 6 months prior to Screening.
* History of any hemoglobinopathy that may affect determination of glycosylated hemoglobin.
* History of infection with hepatitis B, hepatitis C, or human immunodeficiency virus.
* History of a psychiatric disorder that will affect ability to participate in the study.
* History of angioedema in association with use of angiotensin-converting enzyme inhibitors or angiotensin-II receptor inhibitors.
* History of alcohol or substance abuse within the 2 years prior to Screening.
* Receipt of any investigational drug within the 30 days prior to Screening or a history of receipt of an investigational antidiabetic drug within the 3 months prior to Screening.
* Prior treatment in an investigational study of alogliptin.
* Excluded Medications:

  * Treatment with antidiabetic agents other than insulin and metformin is not allowed within the 8 weeks prior to Randomization and through the completion of the end-of treatment or early termination procedures. (Exception: if has received other antidiabetic therapy for less than 7 days within the 3 months prior to Screening.)
  * Treatment with weight-loss drugs, any investigational antidiabetics, or oral or systemically injected glucocorticoids is not allowed from 3 months prior to randomization through the completion of the end-of-treatment or early termination procedures. Inhaled corticosteroids are allowed.
  * Must not take any medications, including over-the-counter products, without first consulting with the investigator.
D: Inclusion Criteria:

* Type 2 diabetes mellitus
* Must have been taking a stable dose of basal or premixed insulin for 8 weeks or longer prior to screening
* If taking metformin, must have been taking the same daily dose for 8 weeks or longer prior to screening
* Insulin type should be intermediate- or long-acting (basal) or premixed (premixed formulation may include short- or rapid-acting insulin as 1 component).
* Inadequate glycemic control (A1C of 7.5% to 11.0%, inclusive)
* Body mass index of 45 kg/m² or lower
* Fasting C-peptide level of 0.8 ng/mL or higher

Exclusion Criteria:

* Symptoms of poorly controlled diabetes, including but not limited to marked polyuria and polydipsia with greater than 10% weight loss during the last 3 months prior to screening or other signs and symptoms
* History of diabetic ketoacidosis or hyperosmolar nonketotic coma
* Women of childbearing potential unable or unwilling to use acceptable birth control
* Women who are pregnant or breastfeeding
* Active liver disease
* Anemia
* Chronic or repeated intermittent corticosteroid treatment (participants receiving stable doses of replacement corticosteroid (except dexamethasone) therapy may be enrolled)
* Use of short- or rapid-acting insulin
* Significant cardiovascular history defined as: myocardial infarction, coronary angioplasty or bypass graft, valvular disease or repair, unstable angina pectoris, transient ischemic attack, or cerebrovascular accident
* Congestive heart failure
* Unstable or rapidly progressing renal disease
* History of alcohol or drug abuse within the previous year
* History of hemoglobinopathies
* Unstable major psychiatric disorders
* Immunocompromised status

Answer: C