Please select the eligibility criteria that correspond to the clinical trial below.
Title: Efficacy and Safety of Vildagliptin in Combination With Insulin in Patients With Type 2 Diabetes
Brief Summary: Many people with type 2 diabetes cannot maintain their target blood glucose levels on a single therapy. The purpose of this study is to assess the safety and effectiveness of vildagliptin, an unapproved drug, in lowering overall blood glucose levels when added to insulin in people with type 2 diabetes who are not at target blood glucose levels on insulin alone.


Options:
A: Inclusion Criteria:

* Blood glucose criteria must be met
* On a stable dose of insulin as defined by the protocol
* Body mass inde (BMI) in the range 22-45

Exclusion Criteria:

* Type 1 diabetes
* Pregnancy or lactation
* Evidence of serious diabetic complications
* Evidence of serious cardiovascular complications
* Laboratory value abnormalities as defined by the protocol
* Other protocol defined exclusion criteria may apply
B: Inclusion Criteria:

* Patient has type 2 diabetes mellitus (T2DM)
* Patient is 18 years of age (or older)
* Patient is not pregnant or breast-feeding and does not plan to become pregnant for the duration of the study and poststudy follow-up period

Exclusion Criteria:

* Patient has a history of type 1 diabetes mellitus or a history of ketoacidosis
* Patient required insulin within the prior 8 weeks
* Patient is on a weight loss program and is not in the maintenance phase
* Patient started on a weight loss medication (e.g., orlistat or sibutramine) within the prior 8 weeks
* Patient is on or likely to require treatment with treatment with immunosuppressive agents (e.g., cyclosporin, methotrexate)
* Patient has cirrhosis, active liver disease (other than fatty liver) or symptomatic gallbladder disease
* Patient has chronic myopathy, or a progressive neurological or neuromuscular disorder (e.g., multiple sclerosis or polymyositis)
* Patient has any of the following disorders within the past 6 months:

Acute coronary syndrome (e.g., MI or unstable angina), Coronary artery intervention, Stroke or transient ischemic neurological disorder.

* Patient has new or worsening signs or symptoms of coronary heart disease within the past 3 months
* Patient has severe peripheral vascular disease
* Patient has congestive heart failure
* Patient is HIV positive
* Patient has a clinically important hematological disorder (e.g., aplastic anemia, myeloproliferative or myelodysplastic syndromes, thrombocytopenia)
* Patient has a history of neoplastic disease
* Patient has a history of alcohol or drug abuse within the past 3 years
* Patient has viral hepatitis (hepatitis B or C)
C: Inclusion Criteria:

* Blood glucose criteria must be met
* Not currently on drug therapy for type 2 diabetes
* Body mass index (BMI) in the range 22-45
* Diagnosis of type 2 diabetes for at least 8 weeks

Exclusion Criteria:

* Pregnancy or lactation
* Type 1 diabetes
* Evidence of serious diabetic complications
* Evidence of serious cardiovascular complications
* Significant laboratory abnormalities as defined by the protocol
* Other protocol-defined exclusion criteria may apply
D: Inclusion Criteria:

* Blood glucose criteria must be met
* Previously responded, as defined by the protocol, to treatment with pioglitazone or rosiglitazone
* Body mass index (BMI) in the range 22-45

Exclusion Criteria:

* Type 1 diabetes
* Pregnancy or lactation
* Evidence of serious cardiovascular complications
* Evidence of serious diabetic complications
* Laboratory value abnormalities as defined by the protocol
* Known sensitivity to pioglitazone
* Other protocol-defined exclusion criteria may apply

Answer: A