Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Phase III Double-blind, Extension, Placebo-controlled Parallel Group Safety and Efficacy Trial of BI 10773 (10 and 25mg Once Daily) and Sitagliptin (100mg Once Daily) Given for Minimum 76 Weeks (Incl. 24 Weeks of Preceding Trial) as Monotherapy or With Different Back-ground Therapies in Patients With Type 2 Diabetes Mellitus Previously Completing Trial 1245.19, 1245.20 or 1245.23
Brief Summary: This study will investigate the efficacy and long term safety and tolerability of BI 10773 in type 2 diabetic patients.


Options:
A: Inclusion Criteria:

* Subjects diagnosed with type 2 diabetes with stable diabetes treatment (unchanged medication and unchanged dose) for 90 days prior to the screening visit including: Monotherapy or any duo-combinations of metformin and/or SUs and/or pioglitazone. Metformin should be used with caution in subjects with moderate renal failure and must be used in accordance with local metformin labelling or guidelines. Or Monotherapy or any combinations of metformin and/or pioglitazone and/or basal or premix insulin. Insulin adjustments (total daily dose) below or equal to 10% within 90 days prior to the screening visit as confirmed by the investigator are acceptable. Metformin should be used with caution in subjects with moderate renal failure and must be used in accordance with local metformin labelling or guidelines. Combination of pioglitazone and insulin should be used with caution and according to local labelling or guidelines
* HbA1c 7-10% (both inclusive)
* Moderate renal impairment diagnosed more than 90 days prior to the screening visit and confirmed by an eGFR (glomerular filtration rate) of 30-59 mL/min/1.73 m2 per MDRD (modification of diet in renal disease) formula at the screening visit
* Body Mass Index (BMI) 20-45 kg/m\^2 (both inclusive)

Exclusion Criteria:

* Recurrent severe hypoglycaemia or hypoglycaemic unawareness as judged by the investigator
* Treatment with antidiabetic medication(s) other than stated in the inclusion criteria in a period of 90 days prior to screening. Previous short-term (below or equal to 7 days in total) treatment with rapid-or short-acting insulin in connection with intercurrent illness is allowed at the discretion of the investigator
* Impaired liver function, defined as ALAT (alanine aminotransferase) above or equal to 2.5 times upper normal limit
* History of chronic pancreatitis or idiopathic acute pancreatitis
* Within the past 180 days any of the following: Episode of unstable angina, acute coronary event, cerebral stroke/transient ischemic attack (TIA) or other significant cardiovascular event (including e.g. arrhythmias or conduction delays on ECG (electrocardiogram))
* Heart failure defined as New York Heart Association (NYHA) class IV
* A systolic blood pressure above or equal to 180 mmHg or a diastolic blood pressure above or equal to 100 mmHg
* Rapidly progressing renal disease (e.g., acute glomerulonephritis) at the discretion of the investigator
* Use of immunosuppressive treatment within 90 days prior to screening
* Diagnosis or treatment for cancer in the previous 5 years (except basal cell skin cancer or squamous cell skin cancer)
* Proliferative retinopathy or maculopathy requiring acute treatment as judged by the investigator
B: Inclusion Criteria:

* Provision of informed consent prior to any study specific procedures
* Female or male aged ≥40 years
* Diagnosed with Type 2 Diabetes
* High Risk for Cardiovascular events

Exclusion Criteria:

* Diagnosis of Type 1 diabetes mellitus History of bladder cancer or history of radiation therapy to the lower abdomen or pelvis at any time
* Chronic cystitis and/or recurrent urinary tract infections
* Pregnant or breast-feeding patients
C: Inclusion Criteria:

* Provision of signed informed consent prior to any study specific procedures
* Male or female, aged ≥18 years
* Established documented diagnosis of symptomatic HFrEF (NYHA functional class II-IV), which has been present for at least 2 months
* LVEF≤40%
* Elevated NT-proBNP levels
* Patients should receive background standard of care for HFrEF and be treated according to locally recognized guidelines
* eGFR ≥30 mL/min/1.73 m\^2 (CKD-EPI formula) at enrolment (visit 1)

Exclusion Criteria:

* Receiving therapy with an SGLT2 inhibitor within 8 weeks prior to enrolment or previous intolerance of an SGLT2 inhibitor
* Type 1 diabetes mellitus
* Symptomatic hypotension or systolic BP \<95 mmHg at 2 out of 3 measurements either at visit 1 or visit 2
* Current acute decompensated HF or hospitalization due to decompensated HF \<4 weeks prior to enrolment
* MI, unstable angina, stroke or transient ischemic attack within 12 weeks prior to enrolment
* Coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting) or valvular repair/replacement within 12 weeks prior to enrolment or planned to undergo any of these operations after randomization
* Implantation of a CRT within 12 weeks prior to enrolment or intent to implant a CRT device
* Previous cardiac transplantation or implantation of a ventricular assistance device or similar device, or implantation expected after randomization
* HF due to restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, hypertrophic (obstructive) cardiomyopathy or uncorrected primary valvular disease
* Symptomatic bradycardia or second or third degree heart block without a pacemaker
* Severe (eGFR \<30 mL/min/1.73 m\^2 by CKD-EPI), unstable or rapidly progressing renal disease at the time of randomization
D: Inclusion criteria:

1. Patients completing the entire treatment period of the preceding double-blind trial 1245.19, 1245.20 or 1245.23 with or without rescue therapy.
2. Signed and dated written informed consent by date of Visit 1 in accordance with Good Clinical Practice and local legislation.

Exclusion criteria:

1. Patient who meet one or more of the withdrawal criteria of the treatment period of the previous trial 1245.19, 1245.20 or 1245.23.
2. Indication of liver disease, defined by serum levels of either alanine aminotransferase , aspartate aminotransferase, or alkaline phosphatase above 3 x upper limit of normal as determined during last visit of preceding trial.
3. Impaired renal function defined as glomerular filtration rate\<30 ml/min (severe renal impairment, Modification of Diet in Renal Disease formula) as determined during last visit of preceding trial.
4. Contraindications to sitagliptin, pioglitazone, metformin or sulfonylurea according to local label, which started during trial participation in 1245.19, 1245.20 or 1245.23
5. Pre-menopausal women (last menstruation \< or = 1 year prior to informed consent) who are nursing or pregnant or are of child-bearing potential and are not practicing an acceptable method of birth control, or do not plan to continue using this method throughout the study and do not agree to submit to periodic pregnancy testing during participation in the trial. Acceptable methods of birth control include tubal ligation, transdermal patch, intra uterine devices/systems, oral, implantable or injectable contraceptives, sexual abstinence (if acceptable by local authorities), double barrier method and vasectomised partner.
6. Alcohol or drug abuse within the 3 months prior to informed consent that would interfere with trial participation or any ongoing condition leading to a decreased compliance to study procedures or study drug intake.
7. Participation in another trial with an investigational drug within 30 days prior to informed consent (except 1245.19, 1245.20 and 1245.23).
8. Any other clinical condition that would jeopardize patient's safety while participating in this clinical trial.

Answer: D