Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Double-Blind Active-Controlled, Phase 3 Trial to Evaluate the Efficacy and Safety of Saxagliptin in Combination With Metformin IR as Initial Therapy Compared to Saxagliptin Monotherapy and to Metformin IR Monotherapy in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control
Brief Summary: The purpose of this trial is to understand if adding saxagliptin to metformin therapy is safe and works better than taking either saxagliptin or metformin alone


Options:
A: 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
B: Inclusion Criteria:

* Have T2DM based on a history and clinical impression that is consistent with the World Health Organization (WHO) Classification of Diabetes
* Have a Clinical Frailty Scale (CFS) score of 4 or above or Total Illness Burden Index (TIBI) score of 5 or above as assessed at screening
* Have an A1c \>7.3% and \<10.9% at study entry and are not achieving desired glycemic control as evidenced by A1c measurement at least 0.4% higher than individualized treatment target set at screening.
* Have been treated for at least 3 months prior to the study entry with any of the following treatment options:

  * Diet/exercise only (only if they have known contraindications to metformin treatment)
  * Any dose of sulfonylurea
  * Effective or maximally-tolerated doses of metformin, dipeptidyl-peptidase-4 (DPP-4) inhibitor, thiazolidinedione, or acarbose used in monotherapy or in dual combination. The following doses are considered to be effective:

    * at least 1500 mg of metformin per day
    * At least 30 mg of pioglitazone per day
    * At least 4 mg of rosiglitazone per day
    * At least 75 mg of acarbose per day
    * Any marketed dose of DPP-4 inhibitor

Exclusion Criteria:

* Are currently enrolled in a clinical trial involving an investigational product or nonapproved use of a drug or device (other than the investigational product used in this study), or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
* Have participated, within the last 60 days in a clinical trial involving an investigational product other than the investigational product used in this study. If the previous investigational product has a long half-life, 3 months or 5 half-lives (whichever is longer) should have passed
* Have previously completed or withdrawn from this study. This exclusion criterion does not apply to participants who are rescreened prior to randomization
* At study entry, have contraindications to sulfonylurea, insulin, or GLP-1 RA
* Have a history of pancreatitis, a personal or family history of medullary thyroid carcinoma, or have Multiple Endocrine Neoplasia syndrome type 2
* Have taken any injectable glucose-lowering agent, miglitol, meglitinide, Sodium/Glucose cotransporter-2 inhibitor, or other antihyperglycemia treatment that is not listed in the fourth inclusion criterion for more than 10 days within 3 months prior to the study entry
* In the opinion of investigator should have an individualized A1c target set at 8% or higher
* Have a body mass index (BMI) greater than 45 kg/m\^2
* Have had more than 1 episode of severe hypoglycemia within 24 weeks prior to the study
* Have cardiac disease with functional status that is Class III or IV according to the New York Heart Association Cardiac Disease Classification
* Have an estimated glomerular filtration rate (eGFR) \<30 milliliter/minute/1.73 m\^2 (mL/min/1.73 m\^2) or advanced renal disease including history of renal transplantation or currently receiving renal dialysis
* Have obvious clinical signs or symptoms or laboratory evidence of liver disease (alanine aminotransferase \[ALT\] or aspartate aminotransferase \[AST\] \> 2.5 times the upper limit of the reference range)
* Receive current therapy for a malignancy, other than basal-cell or squamous-cell skin cancer
* Received systemic glucocorticoids within the 3 months prior to entry for more than 14 consecutive days
* Have any other condition that precludes the participant from following and completing the study
C: Inclusion Criteria: Main Inclusion Criteria:

1. Is male or female and ≥18 and \<75 years old at time of informed consent.
2. Has a HbA1c of ≥7.5% and ≤10.5% based on central laboratory results from Visit 1, with individual need for therapy escalation.
3. Currently treated with a stable maximum tolarated dose (MTD) (≥1500 mg/day) of metformin therapy for at least 8 weeks prior to Enrolment visit.
4. Has a BMI of ≤45 kg/m2 at Enrolment visit.
5. Has a C-peptide laboratory value of ≥1.0 ng/mL (0.33 nmol/L; 333.3 pmol/L) based on central laboratory results from Visit 1.

Main, Exclusion Criteria:

1. Clinically diagnosed with Type I diabetes, known diagnosis of maturity onset diabetes of the young (MODY), or secondary diabetes mellitus or known presence of glutamate decarboxylase 65 (GAD65) antibodies.
2. Patients who, in the judgment of the Investigator, may be at risk for dehydration or volume depletion that may affect the patient's safety and/or the interpretation of efficacy or safety data.
3. Clinically significant cardiovascular disease or procedure within 3 months prior to Enrolment or expected to require coronary revascularization procedure during the course of the study.
4. Concomitant treatment with loop diuretics
D: Inclusion Criteria:

* Type 2 diabetes
* Subjects diagnosed with type 2 diabetes and treated with one or more oral antidiabetic drugs (OADs) for the last 3 months
* HbA1c: 7.0-11.0% (both incl.) for subjects on OAD alone
* HbA1c: 7.0-10.0 % (both incl.) for subjects on OAD combination therapy
* BMI less than 45.0 kg/m\^2

Exclusion Criteria:

* Treatment with insulin within the last 3 months prior to the trial
* Impaired liver or/and renal function
* Significant cardiovascular disease over the last 6 months
* Known retinopathy or maculopathy
* Recurrent major hypoglycaemia or hypoglycaemic unawareness

Answer: A