Please select the eligibility criteria that correspond to the clinical trial below.
Title: The Effect of Liraglutide Compared to Sitagliptin, Both in Combination With Metformin in Subjects With Type 2 Diabetes. A 26-week, Randomised, Open-label, Active Comparator, Three-armed, Parallel-group, Multi-centre, Multinational Trial With a 52-week Extension
Brief Summary: This trial is conducted in Europe and North America. The aim of this trial is to compare the effect on blood sugar control of liraglutide or sitagliptin, both in combination with metformin, in subjects with type 2 diabetes inadequately controlled with metformin alone.

The trial has been extended by 52 weeks. The extension will consist of two 26-week periods:

1. Week 27-52 after randomisation

   - All subjects will continue receiving sitagliptin or liraglutide at unchanged dose and dosing regimen.
2. Week 53-78 after randomisation

   * Subjects receiving sitagliptin at the end of week 52 after randomisation will discontinue sitagliptin and will be randomised 1:1 to liraglutide 1.2 mg/day or liraglutide 1.8 mg/day. Liraglutide will be initiated at a dose of 0.6 mg/day, and increased to 1.2 mg/day or 1.8 mg/day in weekly intervals.
   * Subjects receiving liraglutide 1.2 mg/day or 1.8 mg/day at the end of week 52 after randomisation will continue the treatment at unchanged dose and dosing regimen. Trial completion is planned for June 2010.


Options:
A: Inclusion Criteria:

* Treatment with diet and exercise alone or a stable dose of metformin, or sulfonylurea, or metformin plus a sulfonylurea for at least 3 months.
* Has HbA1c 6.0% to 11.0%, inclusive, at screening.
* Has a body weight of \>= 50 kg at screening.

Exclusion Criteria:

* Received any investigational drug or has participated in any type of clinical trial within 3 months prior to screening.
* Currently participates in any other interventional study.
* Is currently treated with any of the following excluded medications:

  * Sulfonylurea chlorpropamide
  * Thiazolidinedione within 3 months of screening.
  * Αlpha glucosidase inhibitor within 3 months of screening.
  * Meglitinide within 3 months of screening.
  * Insulin within 3 months of screening.
  * Pramlintide within 3 months of screening.
B: Inclusion Criteria:

* Has type 2 diabetes and at least 18 years of age at screening.
* Hemoglobin A1c (HbA1c) of 7.1% to 11.0%, inclusive, at screening.
* Body mass index (BMI) of 25 kg/m2 to 45 kg/m2, inclusive, at screening.
* Have a history of stable body weight (not varying by \>5% for at least 3 months prior to screening).
* Have been treated with metformin(Met) for at least 3 months and have been taking a stable dose for at least 8 weeks prior to screening OR
* Have been treated with metformin(Met) for at least 3 months and have been taking a stable dose for at least 8 weeks prior to screening and have been treated with SU for at least 3 months and have been taking a stable dose of at least an optimally effective dose of brand of SU for 8 weeks prior to screening.

Exclusion Criteria:

* Have had a clinically significant history of cardiac disease or presence of active cardiac disease within the year prior to inclusion in the study, including myocardial infarction, clinically significant arrhythmia, unstable angina, moderate to severe congestive heart failure, coronary artery bypass surgery, or angioplasty; or is expected to require coronary artery bypass surgery or angioplasty during the course of the study.
* Have clinical signs or symptoms of liver disease, acute or chronic hepatitis.
* Have a history of renal transplantation or are currently receiving renal dialysis.
* Have active or untreated malignancy, or have been in remission from clinically significant malignancy (other than basal cell or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer) for less than 5 years.
* Have had greater than three episodes of major hypoglycemia within 6 months prior to screening.
* Have any contraindication for the oral antidiabetic agent which they use.
* Have a known allergy or hypersensitivity to insulin glargine, exenatide once weekly, or excipients contained in these agents.
* Are known to have active proliferative retinopathy.
* Have been treated with drugs that promote weight loss (e.g., Xenical® \[orlistat\], Meridia® \[sibutramine\], Acomplia® \[rimonabant\], Acutrim® \[phenylpropanolamine\], or similar over-the-counter medications) within 3 months of screening.
* Have been treated for longer than 2 weeks with any of the following excluded medications within 3 months prior to screening:

  * Insulin
  * Thiazolidinediones (e.g., Actos® \[pioglitazone\] or Avandia® \[rosiglitazone\])
  * Alpha-glucosidase inhibitors (e.g., Glyset® \[miglitol\] or Precose® \[acarbose\])
  * Meglitinides (e.g., Prandin® \[repaglinide\] or Starlix® \[nateglinide\]).
  * Byetta® (exenatide BID formulation)
  * Dipeptidyl peptidase (DPP)-4 inhibitors (e.g., Januvia™ \[sitagliptin\], Galvus® \[vildagliptin\])
  * Symlin® (pramlintide acetate).
* Have had an organ transplant.
* Have donated blood within 30 days of screening.
* Have previously completed or withdrawn from this study or any other study investigating exenatide once weekly.
* Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
* Are currently enrolled in any other clinical study.
C: Inclusion Criteria:

* Type 2 diabetes
* Treatment with oral anti-diabetic drugs for at least 3 months
* HbA1c: 7.0-11.0 % (both incl.) in subjects on OAD monotherapy. 7.0-10.0 % (both incl.) in subjects on OAD combination therapy
* Body Mass Index (BMI) less than or equal to 45.0 kg/m2.

Exclusion Criteria:

* Treatment with insulin within the last three months
* Treatment with any drug that could interfere with the glucose level
* Any serious medical condition
* Females who are pregnant, have the intention of becoming pregnant or are breastfeeding
D: Inclusion Criteria:

* Type 2 diabetes
* Treatment with metformin alone for at least three months
* HbA1c (glycosylated haemoglobin A1c) 7.5-10.0% (both inclusive)
* Body Mass Index (BMI) less than or equal to 45.0

Exclusion Criteria:

* Previous treatment with insulin, glucagon like peptide-1 (GLP-1) receptor agonists or dipeptidyl peptidase-4 (DPP-4) inhibitors
* Treatment with anti-diabetic drugs other than metformin within the last three months
* Any serious medical condition
* Females who are pregnant, have the intention of becoming pregnant or are breastfeeding

Answer: D