Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomized, Parallel Group, Double-blind, Multi-center Study Comparing the Efficacy and Safety of AVANDAMET and Metformin After 80 Weeks of Treatment.
Brief Summary: This study will evaluate the longer-term glycemic effect of two medicines approved for initial treatment of type 2 diabetes. The study consists of a 2 week screening period (2 study visits), followed by an 80 week double-blind treatment period (11 study visits). Also, a sub-study was included to look at changes in bone mineral density (BMD) at the lumbar spine.


Options:
A: Inclusion Criteria:

* The subject provides written informed consent.
* The subject is male or female and 18 to 75 years of age at the time of pre-screening.
* The subject has an established clinical diagnosis of type 2 diabetes according to recommended guidelines (e.g., American Diabetes Association, International Diabetes Federation, World Health Organization, Canadian Diabetes Association, or American Association of Clinical Endocrinologists).
* The subject is currently treated with diet and exercise, and has not taken more than 2 weeks of an anti-diabetic monotherapy or insulin in the past 6 months.
* The subject has a BMI \>25 kg/m2 at pre-screening.
* The subject has a Quest HbA1c 7.5% to 10.5% at pre-screening.
* The subject has a fasting capillary blood glucose 126 mg/dL (7mmol/L), as measured by the site staff at week 0.
* If the subject is a pre-menopausal female of child-bearing potential, she agrees to practice acceptable contraceptive measures (e.g. oral birth control pills, Norplant, Depo-Provera, an intrauterine device (IUD), a diaphragm with spermicide or a condom with spermicide, or abstinence) at least 1 month before screening, during the study, and for 30 days after the last dose of study medication is taken
* The subject is able and willing to perform self-monitoring of blood glucose as specified in this protocol.

Exclusion Criteria:

* The subject has taken an oral anti-diabetic monotherapy or insulin for more than 14 days in the past 6 months.
* The subject has presence of clinically significant renal or hepatic disease (serum creatinine 1.5 mg/dL (132.6 mol/L) for males and 1.4 mg/dL (123.8 mol/L) for females): ALT, AST, total bilirubin, or alkaline phosphatase \>2.5 times the upper limit of the normal (ULN) reference range.
* The subject has anemia defined by hemoglobin concentration \<11g/dL (110g/L) for males or \<10g/dL (100g/L) for females.
* Presence of unstable or severe angina, coronary insufficiency or New York Heart Association (NYHA) class III-IV or any congestive heart failure requiring pharmacologic treatment.
* The subject has systolic blood pressure \>160 mmHg or diastolic blood pressure \>90 mmHg
* The subject has a chronic disease requiring intermittent or chronic treatment with oral, intravenous, or intra-articular corticosteroids (i.e., only use of topical, inhaled or nasal corticosteroids is permitted).
* The subject has acute or chronic metabolic acidosis or a history of diabetic ketoacidosis.
* The subject has a clinically significant abnormality which in the judgment of the investigator makes the subject unsuitable for inclusion in the study (e.g., physical examination, laboratory tests, or electrocardiogram, etc).
* The subject has used an investigational agent within 30 days or 5 half-lives (whichever was longer) prior to pre-screening.
* The subject is a female who is lactating, pregnant, or planned to become pregnant.
* The subject has a prior history of severe edema or a medically serious fluid related event (e.g., heart failure).
* The subject has a history of macular edema.
* The subject has significant hypersensitivity (e.g., difficulty swallowing, difficulty breathing, and tachycardia or skin reaction) to TZDs, biguanides, or compounds with similar chemical structures.
* The subject has a diagnosis of cancer (other than squamous, basal cell, or cervical cancer in-situ) in the past 3 years and is receiving treatment for cancer.
* The subject has a history or suspicion of drug abuse or alcohol abuse within the last 6 months.
* The subject is known to have severe lactose intolerance.
* The subject is not willing to comply with visits and procedures described in the protocol.
* The subject has a disease that may affect bone turnover including, but not limited to: Paget's disease, hypercalcemia, hypocalcemia, hyperparathyroidism, hyperthyroidism, osteomalacia, metastatic bone disease
* The subject has a weight of greater than 300 lbs (136.4 kg).
* The subject has received treatment with bisphosphonates (≥1 month cumulative treatment within the last 12 months) or fluoride (dose greater than 10mg/day within the previous 5 years).
B: Inclusion Criteria:

* Type 2 diabetes
* Inadequate blood sugar control
* No current treatment with other medications to lower blood sugar

Exclusion Criteria:

* Major heart, liver or kidney problems
* Pregnant or breast feeding
C: Inclusion Criteria:

* Newly Diagnosed Type 2 Diabetes Mellitus patients not receiving any medication for diabetes
* HbA1c ranging from 7.0% to ≤ 8.5%
* Body Mass Index (BMI) ≥ 19.0 to ≤ 25.0 kg/m2
* Male and female subjects of age between 20 - 60 years shall be selected
* Adult subjects willing to give informed consent
* Subject must be available for and willing to attend all evaluation visits
* Willingness to follow the protocol requirements as evidenced by written informed consent
* Subject must have access to telephone for calling into the clinical center as part of test product compliance

Exclusion Criteria:

* Type 1 diabetes
* BMI ≤18.99 kg/m2 or\> 25 kg/m2
* Presence of severe vascular complications
* Indications for use of insulin
* Elevated serum levels of lipase and amylase (\>1.5 ULN)
* Gamma-glutamyltransferase \>2 times upper limit of normal (ULN) at Visit1, confirmed by repeated measure within 3 working days
* Urine albumin: creatinine ratio (UACR) \>1800 mg/g (\>203.4 mg/mmol)
* Subjects below the age of 20 years and above the age of 60 years
* History of any drug abuse in the past 12 months
* History of hypersensitivity to study drugs and related drugs or excipients in the formulation.
* History of allergy to vegetables and or food substances and or any other manifestations suggestive of hypersensitivity reactions
* Subject who is not willing to participate in the study
* Clinically significant abnormal laboratory results at screening.
* Subject is being treated for severe active infection of any type
* A female subject who is breast-feeding, pregnant, or intends to become pregnant during the study
* Subject with clinically relevant uncontrolled medical condition (e.g hematologic renal hepatic neurology cardiac or respiratory)
* Subject has evidence of active malignancy, or prior history of active malignancy that has not been in remission for at least 5 years
* Participating in a clinical research trial within 30 days prior to screening
* Donated blood 3 months prior to first study visit and during the study period
* Individuals who are cognitively impaired and or who are unable to give informed consent
* Known HIV or Hepatitis B or C positive
* Any other health or mental condition that in the Investigator's opinion may adversely affect the subjects ability to complete the study or its measures or that may pose significant risk to the subject
D: Inclusion Criteria:

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

Exclusion Criteria:

* History of type 1 diabetes
* Evidence of significant diabetic complications
* Serious cardiovascular events within the past 6 months
* Laboratory value abnormalities as defined by the protocol
* Other protocol-defined exclusion criteria may apply

Answer: A