Please select the eligibility criteria that correspond to the clinical trial below.
Title: The Effect of Insulin Degludec on Risk of Symptomatic Nocturnal Hypoglycaemia in Subjects With Type 1 Diabetes and High Risk of Nocturnal Severe Hypoglycaemia
Brief Summary: The purpose of this study is to determine whether insulin degludec compared to insulin glargine can reduce the risk of symptomatic nocturnal hypoglycaemia in subjects with the greatest potential benefit from optimised insulin treatment, which are patients with type 1 diabetes and high risk of nocturnal severe hypoglycaemia.


Options:
A: Inclusion Criteria:

* Type 1 diabetes \> 5 years
* One or more episodes of nocturnal severe hypoglycaemia during the preceding two years
* Treated with multiple dose insulin injection (\>2) or insulin pump. Both human insulin and insulin analogues are allowed
* Willingness to a once daily (OD) regimen concerning insulin degludec and insulin glargine
* Willingness to do self-monitoring of blood glucose (SMBG) and keep a diary
* Signed informed consent

Exclusion Criteria:

* History of primary and secondary adrenal insufficiency, growth hormone deficiency, or untreated myxoedema
* History of unstable angina or major cardiovascular events (myocardial infarction, coronary re-vascularisation, transient ischaemic attack, or stroke within the last three months)
* Heart failure, New York Heart Association (NYHA) class IV
* History of malignancy unless a disease-free period exceeding five years
* History of alcohol or drug abuse
* Treatment with glucose lowering agent(s) other than insulin
* Pregnant or lactating women
* Women of childbearing potential who are not using chemical (P-pills or gestagen depots) or mechanical (intra-uterine device) contraception
* Participation in another investigational drug study within the last 3 months
* Inability to understand the informed consent
* HbA1c \> 86 mmol/mol (10%)
* Shifting working hours
B: Inclusion Criteria:

* Insulin detemir naive
* Type 1 diabetes for at least 12 months
* HbA1c lesser than or equal to 11.0%

Exclusion Criteria:

* Significant concomitant diseases
C: Inclusion Criteria:

* FOR THE MAIN TRIAL, NN5401-3594:
* Type 1 diabetes mellitus for at least 12 months
* Ongoing daily treatment with insulin (in a basal bolus regimen, premix insulin regimen, self mix regimen) for at least 12 months
* HbA1c 7.0-10.0% (both inclusive)
* BMI (Body Mass Index) below or equal to 35.0 kg/m\^2
* FOR THE EXTENSION TRIAL, NN5401-3645:
* The subject must have completed the six-month treatment period in trial NN5401-3594

Exclusion Criteria:

* FOR THE MAIN TRIAL, NN5401-3594:
* Treatment with other insulin regimens than insulin in a basal bolus regimen/premix insulin regimen/self mix regimen within 3 months
* Cardiovascular disease within the last 6 months
* Uncontrolled treated/untreated severe hypertension
* Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures according to local requirements
* Cancer and medical history of cancer
* FOR THE EXTENSION TRIAL, NN5401-3645:
* Anticipated significant lifestyle changes during the trial
* Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures
D: Inclusion Criteria:

* Type 1 diabetes mellitus for at least 12 months
* Current treatment with any basal bolus insulin for at least 12 months
* HbA1c below or equal to 10.0%
* BMI (Body Mass Index) below or equal to 35.0 kg/m\^2
* For the extension trial only: Completion of the 52 week treatment period in trial NN1250-3583 (NCT00982228)

Exclusion Criteria:

* Use of any other antidiabetic drug than insulin within the last 3 months
* Cardiovascular disease within the last 6 months
* Uncontrolled treated/untreated severe hypertension
* Recurrent severe hypoglycemia or hypoglycemic unawareness or hospitalisation for diabetic ketoacidosis during the previous 6 months
* Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures according to local requirements
* Cancer and medical history of cancer

Answer: A