Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Phase IIIb, Multicenter, Multinational, Randomized, Double-blind, Placebo Controlled, Parallel Group Study to Evaluate the Glycemic and Renal Efficacy of Once Daily Administration of Linagliptin 5 mg for 24 Weeks in Type 2 Diabetes Patients, With Micro- or Macroalbuminuria (30-3000mg/g Creatinine) on Top of Current Treatment With Angiotensin ConvEnzyme Inhibitor or Angiotensin Receptor Blocker - MARLINA (Efficacy, Safety & Modification of Albuminuria in Type 2 Diabetes Subjects With Renal Disease With LINAgliptin)
Brief Summary: Evaluate linagliptin in terms of glycemic control as defined by HbA1c after 24 weeks of treatment and in terms of renal efficacy as defined by changes in albuminuria (UACR) after 24 weeks of treatment.


Options:
A: Inclusion Criteria:

* Type 1 diabetics with proteinuria willing to be seen weekly for the evaluation of renal function

Exclusion Criteria:

* Associated active medical diseases that would not permit evaluation of stable renal disease over 18 months
B: Inclusion criteria:

* Diagnosis of type 2 diabetes mellitus
* Glycosylated Hemoglobin (HbA1c) between 6.5 and 10% (inclusive)
* Current therapy with ACEi or ARB at stable dose for 10 weeks
* Urinary albumin-to-creatinine ratio (UACR): 30-3000 mg/g creatinine documented in the previous 12 months or detected at Screening.
* Estimated Glomerular Filtration Rate (eGFR) greater than 30 ml/min.
* Age between 18 and 80 years.

Exclusion criteria:

* Dual or triple blockade of the Renin Angiotensin System (RAS)
* Uncontrolled hyperglycaemia
* Mean arterial blood pressure \> 110 mmHg
* Known hypersensitivity or allergy to the investigational product, or their excipients (including matching placebos).
* Treatment with a glitazone within 6 months prior to informed consent.
* Treatment with a DiPeptidyl-Peptidase 4 (DPP-4) inhibitor, a Glucagon Like Peptide-1 (GLP-1) agonist, a Sodium/Glucose coTransporter 2 (SGLT2) inhibitor, a dopamine-agonist, a bile-acid sequestrant a short acting (prandial) insulin or premixed insulin within 10 weeks prior to informed consent.
* Treatment with anti-obesity drugs 10 weeks prior to informed consent.
* Alcohol or drug abuse within 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 in the opinion of the investigator.
* Current treatment with systemic steroids (glucocorticoids) at time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent.
* Participation in another trial with an investigational drug within 2 months prior to informed consent.
C: Inclusion Criteria:

* Female and male patients aged between 18 and 70 years
* Type 2 diabetes without diabetic nephropathy (definition see exclusion criteria)

Exclusion Criteria:

* Any other form of diabetes mellitus than type 2 diabetes mellitus
* Use of insulin, glitazone or gliptins within the past 3 months
* Any other oral antidiabetic drug that can not be discontinued for the study period.
* Any history of stroke, transient ischemic attack, instable angina pectoris, or myocardial infarction within the last 6 months prior to study inclusion
* Urinary albumin excretion (UACR) \> 100 mg/g (early morning spot urine)
* eGFR \<45 ml/min/1.73m² (MDRD Formula)
* Uncontrolled arterial hypertension (RR ≥180/ ≥110mmHg)
* HbA1c ≥ 10%
* Fasting plasma glucose ≥ 240 mg/dl
* Body mass index ≥ 40 kg/m²
* Triglyceride levels ≥ 1000 mg/dl
* HDL-cholesterol levels \<25 mg/dl
* Overt congestive heart failure (CHF) or history of CHF
* Severe disorders of the gastrointestinal tract or other diseases which interfere the pharmacodynamics and pharmacokinetics of study drugs
* Significant laboratory abnormalities such as SGOT or SGPT levels more than 3 x above the upper limit of normal range, serum creatinine \> 2mg/dl
* Drug or alcohol abuses
* Pregnant or breast-feeding patients
* Any patient currently receiving chronic (\>30 consecutive days) treatment with an oral corticosteroid
* Patients being treated for severe auto immune disease e.g. lupus
* Participation in another clinical study within 30 days prior to visit 1
* Individuals at risk for poor protocol or medication compliance
* Subject who do not give written consent, that pseudonymous data will be transferred in line with the duty of documentation and the duty of notification according to § 12 and § 13 GCP-V
D: Inclusion Criteria: - Type 2 diabetes - Age above or equal to 50 years with predefined previous cardiovascular disease(s) or renal disease or age above or equal to 60 years with predefined cardiovascular risk factors - HbA1c (glycosylated haemoglobin) above or equal to 7.0% or HbA1c below 7.0% and current insulin treatment corresponding to above or equal to 20 U of basal insulin per day - One or more oral or injectable antidiabetic agent(s) Exclusion Criteria: - An acute coronary or cerebrovascular event in the previous 60 days - Planned coronary, carotid or peripheral artery revascularisation - Chronic heart failure NYHA (New York Heart Association) class IV - Current or past (within the last 5 years) malignant neoplasms (except basal cell and squamous cell skin carcinoma)

Answer: B