Please select the eligibility criteria that correspond to the clinical trial below.
Title: Testosterone Therapy of Men With Type 2 Diabetes Mellitus (T2DM) - a Randomised, Doubleblinded and Placebocontrolled Trial of Men With Subnormal Testosterone Levels and T2DM.
Brief Summary: A randomized, placebo-controlled, double-blinded study on 40 men with type 2 DM.

Type 2 diabetes mellitus (T2DM) is a common endocrine disorder characterized by hyperinsulinaemia and insulin resistance.

Hypothesis Testosterone therapy increases lean body mass and insulin sensitivity in men with low normal levels of bioavailable testosterone and type 2 DM.


Options:
A: Inclusion Criteria:

* Men between 45 and 80 years age
* Participants with low serum testosterone concentrations (\< 300 ng/dL) who exhibit at least one sign or symptom of hypogonadism and have evidence of cardiovascular (CV) disease or are at an increased risk for CV disease.

Exclusion Criteria:

* Participants with congenital or acquired hypogonadism for whom long-term therapy with placebo would not be medically appropriate
* Participants with prostate specific antigen (PSA) \> 3.0 ng/mL (or 1.5 if on 5-alpha reductase inhibitors)
* Participants who have been treated with testosterone in the past 6 months and for whom testosterone therapy is contraindicated
* Confirmed testosterone \< 100 ng/dL
* Body Mass Index (BMI) \> 50
* Hemoglobin A1c (HbA1C) \> 11%
* Hematocrit (Hct) \> 50%
* Estimated Glomerular Filtration Rate (eGFR) \< 30 ml/min
* History of deep vein thrombosis or pulmonary embolism or prostate cancer or heart failure (Class III and IV).
B: Inclusion Criteria:

* Male gender age 50-70
* Bioavailable testosterone \< 7,3 nmol/L
* Metformin treatment of T2DM for 3 months or more

Exclusion Criteria:

* HbA1c \> 9,0 %, BMI \> 40 kg/m2, Haematocrit \> 50%,
* Known malignant disease, PSA \> 3 ug/L, Nycturia \> 3 times,
* Abnormal routine blood samples,
* Severe hypertension,
* Significant EKG-changes,
* Wish of parenthood,
* Active mental illness,
* former or present abuse,
* Severe illness of heart-, lung- or kidney,
* Primary or secondary hypogonadism.
C: Inclusion Criteria:

* Community dwelling, ages 65 and older
* Self-reported difficulty in climbing 10 steps without resting, or difficulty in walking 2 or 3 blocks outside on level ground
* A score of 4 to 9 on the Short Physical Performance Battery (mild to moderate physical impairment)
* Total serum testosterone level (TT) \< 350 ng/dL and \> 100 ng/dL
* Without dementia (Mini-Mental State Examination \[MMSE\] score \> 24)

Exclusion Criteria:

* Use of testosterone, anabolic steroids, dehydroepiandrosterone (DHEA), androstenedione or recombinant growth hormone (rGH) in the past year
* Alcohol or drug abuse
* Use of anti-convulsants or glucocorticoids (equivalent to prednisone \> 20 mg/day)
* Prostate cancer, breast cancer or other cancers with life expectancy \< 5 years
* Limiting neuromuscular, joint or bone disease, or history of stroke with residual neurological problems
* Any neurological condition that would impact cognitive functioning including:

  * epilepsy
  * multiple sclerosis
  * HIV
  * Parkinson's disease
  * stroke
  * other focal lesion
* Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) Axis I psychiatric disorder in past year or use of psychotropic medications in 6 months
* Abnormal prostate examination; PSA \> 4 ng/mL; or BPH symptom score \> 21
* Unstable angina, New York (NY) class III or IV congestive heart failure or myocardial infarction within 3 months of entry
* Abnormal laboratory values (at discretion of principal investigator)
* Untreated thyroid disease; systolic blood pressure \> 160 or diastolic \> 100 mm Hg
* Body mass index \> 40 kg/m2
* Untreated severe obstructive sleep apnea
D: Inclusion Criteria:

* Total testosterone level \<300 nanogram per deciliter (ng/dL) \[10.4 nanomole per Liter (nmol/L)\] at each of 2 screening visits
* At least 1 symptom of testosterone deficiency, which must include decreased energy or decreased sexual drive
* Prostate Specific Antigen (PSA) \<4 nanogram per milliliter (ng/ml) at screening

Exclusion Criteria:

* Sexual partner who is or becomes pregnant at any time during the study
* Use of long-acting intramuscular (IM) testosterone undecanoate or testosterone pellets in the 6-month period prior to screening
* Body Mass Index (BMI) \>37 kilogram per square meter (kg/m\^2) at screening
* Severe lower urinary tract symptoms and/or significant prostate enlargement
* Prolactin lab test result of \>30 ng/mL at screening
* Hemoglobin A1c (HbA1c) \>11% at screening
* Hematocrit ≥50% (\>54% at elevated altitude) at screening
* Current use of any medications, herbal, and/or nutritional supplements that can interfere with testosterone
* Dermatologic condition in underarm area that might interfere with testosterone absorption (for example, eczema) or be exacerbated by topical testosterone replacement therapy
* Currently receiving treatment with cancer chemotherapy or antiandrogens
* Chronic use of systemic glucocorticoids (use for \>14 days within the 3 months prior to screening); use of non-testosterone anabolic steroids within 12 months prior to screening
* Competitive athletes involved in a sport in which they may be screened for anabolic steroids
* History of use of estrogenizing agents within 12 months prior to screening
* History of luteinizing hormone-releasing hormone antagonist or agonist treatment in the last 6 months prior to screening
* History of clomiphene or other anti-estrogen treatment in the 3 months prior to screening
* Use of finasteride within 3 months prior to screening, or use of dutasteride within 6 months prior to screening
* Current use of warfarin or phenprocoumon
* History of frequent opioid use: \>1 time/week during any week within 30 days prior to screening
* Current use of dopamine receptor agonists (cabergoline, pergolide, bromocriptine)
* Have a history of significant central nervous system injuries or disease (including stroke, spinal cord injury, or multiple sclerosis) within 6 months prior to screening
* Systolic blood pressure \>170 or \<90 millimeter of mercury (mm Hg) or diastolic blood pressure \>100 or \<50 mm Hg at screening or a history of malignant hypertension
* History of unstable angina as defined by Braunwald Classification of Unstable Angina or angina occurring during sexual intercourse in the last 6 months
* History of any of the following coronary conditions within 90 days of screening: myocardial infarction, coronary artery bypass graft surgery, percutaneous coronary intervention (angioplasty or stent placement)
* Have any supraventricular arrhythmia with an uncontrolled ventricular response \[mean heart rate \>100 beats per minute (bpm)\] at rest, or have any history of spontaneous or induced sustained ventricular tachycardia (heart rate \>100 bpm for ≥30 seconds), or use of an automatic internal cardioverter-defibrillator
* Have a history of sudden cardiac arrest
* Exhibit any evidence of congestive heart failure \[New York Heart Association (NYHA) Class 2 or above\], within 6 months prior to screening
* Have had a new, significant cardiac conduction defect within 90 days prior to screening
* Clinical suspicion (or history) of prostate cancer during digital rectal examination at screening
* Known or suspected breast cancer (or history of breast cancer) or other active cancer (with the exception of nonmelanotic skin cancer)
* Exhibit evidence of severe renal impairment \[creatinine clearance \<30 milliliter per minute (mL/min) as determined by the Cockcroft-Gault formula\] at screening
* Exhibit a history of severe liver disease or clinical evidence of hepatic impairment at screening
* Have a history of human immunodeficiency virus (HIV) infection
* Severe sleep apnea
* Untreated hypothyroidism, hypercortisolism or other significant endocrinopathy (other than hypogonadism) that contributes to symptoms of low energy or fatigue

Answer: B