Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Clinical Study to Assess the Efficacy and Safety of Three Doses of Vildagliptin in Patients With Type 2 Diabetes
Brief Summary: The purpose of this study is to assess the safety and effectiveness of three doses of vildagliptin, an unapproved drug, compared to placebo in lowering overall blood glucose levels in people with type 2 diabetes who have not been previously treated with drug therapy to lower their blood sugar.


Options:
A: Inclusion Criteria:

* Female, \>55 to \<80 years
* \>5 years menopausal
* Type 2 Diabetes Mellitus (T2DM) diagnosis according to American Diabetes Association (ADA), American Association of Clinical Endocrinologists (AACE), Canadian Diabetes Association (CDA), World Health Organization/International Diabetes Federation (WHO/IDF)
* Drug-naïve (HbA1c \< or = 9.0%); OR Prior monotherapy, submaximal doses of metformin (\< or = 1000mg Metformin), sulfonylureas (\< or = 5mg Glyburide, \< or = 10mg Glipizide or \< or = 8mg glimepiride) or full dose Januvia (100mg) (HbA1c \< or = 8.5%); OR Prior monotherapy, \> submaximal doses of metformin (\>1000mg) or sulfonylureas (\>5mg Glyburide, \>10mg Glipizide or \>8mg glimepiride) (HbA1c \< or = 7.0%)
* Weighs \<300 lbs (136.4 kg)
* Two or more vertebra (L1-L4) suitable for BMD measurement by dual x-ray absorptiometry (DXA)
* Absolute BMD value consistent with T-score \>-2.5 at femoral neck, lumbar spine and total hip

Exclusion Criteria:

* Type 1 Diabetes Mellitus (T1DM) or history of diabetic ketoacidosis (DKA)
* Renal or hepatic disease (clinically significant)
* Hepatocellular reaction, severe edema, or medically serious fluid event associated with thiazolidinedione (TZD)
* Recent (\<6mos) history or clinical intervention for angina or myocardial infarction or is taking nitrates
* Any stage of heart failure, i.e. New York Heart Association (NYHA) class I-IV
* Systolic BP \>160mmHg or diastolic BP \>90mmHg while on antihypertensive
* Hypersensitivity to TZDs, biguanides
* Prior treatment with two or more oral anti-diabetic (OAD) agents
* Bilateral hip replacements
* Concurrent diseases affecting bone metabolism
* Active malabsorption syndrome
* Serum calcium outside the central lab reference range
* Thyroid replacement therapy, serum thyroid stimulating hormone (TSH) must be within range
* Vitamin D deficiency
* Previous treatment with: strontium, intravenous (IV) bisphosphonate, fluoride, hormones, calcineurin inhibitors or methotrexate
* Chronic systemic corticosteroid \[e.g. glucocorticoid, mineralocorticoid\] treatment of no more than two intra-articular injections within the past year or use of oral parenteral, or long-term, high-dose inhaled corticosteroids
B: Adults 20-75 with a diagnosis of type 2 diabetes mellitus who are not adequately controlled with diet and exercise, and have an HbA1c greater than 6.7%
C: Inclusion Criteria:

* Type 2 diabetes mellitus
* Drug naive
* Hemoglobin (Hb) A1c \>= 7.0% and \<= 10.0% (\>10% and \<= 12% for open label arm)
* Fasting C-peptide \>= 1 ng/mL
* Body mass index \<= 40 kg/m2

Exclusion Criteria:

* Symptomatic poorly controlled diabetes
* Recent cardiac or cerebrovascular event
* Serum creatinine \>= 1.5 mg/dL for males and \>= 1.4 mg/dL for Women of Child Bearing Potential
D: Inclusion Criteria:

* Body mass index (BMI) in the range 22-45
* Blood glucose criteria must be met
* Not currently on drug therapy for type 2 diabetes

Exclusion Criteria:

* Type 1 diabetes
* Evidence of serious diabetic complications
* Evidence of serious cardiovascular conditions
* Laboratory value abnormalities as defined by the protocol
* Other protocol-defined exclusion criteria may apply

Answer: D