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


Options:
A: Inclusion Criteria:

* Patients with type 2 diabetes mellitus
* Patient is not pregnant or breastfeeding
* Male or female patient unlikely to conceive
* Patient not on an antihyperglycemic drug

Exclusion Criteria:

* Patient has history of type 1 diabetes mellitus
* Patient has history of ketoacidosis
* Patient requires insulin within 8 weeks prior to start of study
* Patient on weight loss program and is not in maintenance phase
* Patient taking weight loss medication within 8 weeks prior to start of study
* Patient on or likely to require = 14 days or repeated courses of corticosteroids
* Patient taking immunosuppressive/immunomodulating medication
* Patient taking digoxin or other cardiac medication
* Patient has undergone surgical general anesthesia within 30 days prior to start of study
* Patient taking investigational drug within 8 weeks prior to start of study
* Patient is diagnosed with liver disease
* Patient has chronic myopathy, progressive neurological/neuromuscular disorder
* Patient has with severe cardiac conditions within the last 6 months
* Patient is Human immunodeficiency virus (HIV) positive
* Patient has hematological disorder
* Patient has history of malignancy
* Patient has history of alcohol or drug abuse within the past 3 years
B: Inclusion Criteria:

* Blood glucose criteria must be met
* On a stable dose of metformin as defined by the protocol
* Body mass index (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
C: Inclusion Criteria:

* Not previously treated with oral antidiabetic agents as defined by the protocol
* Blood glucose criteria must be met
* Body mass index (BMI) in the range 22-45

Exclusion Criteria:

* Pregnancy or lactation
* Type 1 diabetes
* Evidence of serious diabetic complications
* Evidence of serious cardiovascular complications
* Laboratory value abnormalities as defined by the protocol
* Known sensitivity to pioglitazone
* 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: B