Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of the Addition of MK0431 to Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Pioglitazone Therapy
Brief Summary: The purpose of this study is to determine the safety and efficacy of an investigational drug in patients with type 2 diabetes mellitus.


Options:
A: 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
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
* 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
D: 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

Answer: B