Please select the eligibility criteria that correspond to the clinical trial below.
Title: Epidemiology of Diabetes Interventions and Complications (EDIC)
Brief Summary: The Diabetes Control and Complications Trial (DCCT,1983-1993) compared intensive therapy aimed at near-normal glycemia versus conventional therapy with no specific glucose targets in 1441 subjects with type 1 diabetes (T1DM) over a mean follow-up of 6.5 years. Intensive therapy reduced the risks of retinopathy, nephropathy, and neuropathy by 35-76%. The level of glycemia was the primary determinant of complications. We also described the adverse effects of intensive therapy; assessed its effects on cardiovascular disease (CVD) risk factors, neurocognition and quality of life; and projected the lifetime health-economic impact. After the primary DCCT results were reported in 1993, intensive therapy aiming for a HbA1c \<7% was adopted world-wide as standard-of-care for T1DM.

The Epidemiology of Diabetes Interventions and Complications (EDIC, 1994-present) is the observational follow-up study of the DCCT cohort. Micro- and cardio-vascular complications and a wide range of established and putative risk factors, including genetic and epigenetic factors, have been measured with standardized methods, carefully documented and events adjudicated. EDIC has notably shown that the early beneficial effects of intensive versus conventional therapy on complications persisted for \~15 years despite the convergence of HbA1c levels in the two groups during EDIC, a novel concept termed metabolic memory. Prior intensive therapy was also shown to reduce substantially the risk of CVD events and mortality.

The overarching goals for the current cycle (2022-2027) are to study the occurrence and identify potentially modifiable risk factors of the more advanced microvascular and cardiovascular complications and physical and cognitive dysfunction that are occurring with increasing diabetes duration and age. With increasing longevity, the increased adiposity that has affected patients with T1DM, including EDIC participants, has potential adverse consequences. Thus, the impact of diabetes duration, aging and adiposity on morbidities and their underlying risk factors will be studied. The results will guide treatment priorities as T1DM patients age.


Options:
A: Inclusion Criteria:

* Adults ≥18 to ≤80 years of age
* History of T2DM for at least 6 months prior to screening
* Moderate to severe renal impairment and not actively on dialysis
* Willing and able to perform self-monitoring of blood glucose
* Willing and able to provide written informed consent

Exclusion Criteria:

* History of type 1 diabetes mellitus, diabetic ketoacidosis (within the previous 6 months), or diabetes resulting from pancreatic disorder or secondary diabetes (from acromegaly and/or Cushing's disease)
* Subjects who have received a renal allograft
* Subjects expecting to require dialysis or to undergo kidney transplantation within 3 months of study dosing
* Presence of active hepatic disease or clinically significant abnormal liver function tests at Screening or planned study Day -1
* Subjects with a history of heart attack, severe/unstable angina, or coronary revascularization procedure within 6 months prior to study Day -2
* History of clinically significant cardiac arrhythmias within 1 year prior to study Day -2
* Subjects with congestive heart failure
* Subjects with uncontrolled Stage III hypertension
* History of 2 or more emergency room visits, doctors' visits, or hospitalizations due to hypoglycemia within the 6 months prior to planned study Day -2
* History of alcohol or illicit drug abuse within 1 year prior to Screening
* History of human immunodeficiency virus (HIV), hepatitis B, or hepatitis C
* Major surgery within 6 months prior to planned study Day -2
* History of any malignancy within the last 5 years
* Triglycerides \>1000 mg/dL at Screening or planned study Day -1
* History of any serious adverse reaction or hypersensitivity to an SGLT inhibitor
* Use of corticosteroids within 2 weeks prior to study Day 1
* Use of any investigational drug within 30 days prior to study Day 1, or investigational protein or antibodies within 60 days of Day 1
* Positive urine pregnancy test at Screening
* Positive urine screen for illicit drug abuse at Screening
* Prior exposure to LX4211
B: Inclusion criteria:

1. Patients \>=18 years with type 2 diabetes
2. HbA1c of \>= 7.0% (53 mmol/mol) and =\< 10% (86 mmol/mol)
3. Mean seated systolic blood pressure 130-159 mmHg and diastolic blood pressure 80-99 mmHg

Exclusion criteria:

1. Uncontrolled hyperglycaemia with a glucose level \>240 mg/dl (\>13.3 mmol/L) after an overnight fast before randomization
2. Known or suspected secondary hypertension
3. Acute coronary syndrome (non-STEMI, STEMI and unstable angina pectoris), stroke or transient ischemic attack within 3 months prior to informed consent
C: Participants originally enrolled in the Diabetes Control and Complications Trial (DCCT) (N01-DK-6-2204-A).
D: Inclusion Criteria:

* Type 2 diabetes
* eGFR \> 60 mL/min/1.73 mq (for the patients without renal failure)
* eGFR 10-60 mL/min/1.73 mq (for the patients with renal failure)

Exclusion Criteria:

* Type 1 diabetes
* Hypersensitivity to Linagliptin or excipients
* Intolerance to other DPP-4 inhibitors
* Terminal renal failure (eGFR \< 10 mL/min/1.73 mq)
* Use of GLP-1 analogs or other DPP-4 inhibitors
* Recent (within 1 month) trauma or surgery or acute diseases
* Any acute or chronic inflammatory condition
* Immunosuppression or organ transplantation
* Pregnancy or lactation
* Inability to provide informed consent.

Answer: C