Please select the eligibility criteria that correspond to the clinical trial below.
Title: NN5401-3594: A 26-week, Open-labelled, Two-arm, Parallel, Randomised Trial Comparing Efficacy and Safety of NN5401 Once Daily Plus Insulin Aspart vs. Basal-bolus Treatment With Insulin Detemir Plus Insulin Aspart in Subjects With Type 1 Diabetes / NN5401-3645: An Extension Trial Comparing Safety and Efficacy of NN5401 Plus Meal-time Insulin Aspart for the Remaining Meals With Insulin Detemir Plus Meal-time Insulin Aspart in Type 1 Diabetes (BOOST™: T1)
Brief Summary: This trial is conducted in Europe, Oceania, and the United States of America (USA).

The aim of this clinical trial is to compare NN5401 (insulin degludec/insulin aspart (IDegAsp)) with insulin detemir (IDet) plus insulin aspart in patients with type 1 diabetes (main period) followed by the extension period comparing the long-term safety of NN5401 plus insulin aspart with insulin detemir plus insulin aspart.

The main period is registered internally at Novo Nordisk as NN5401-3594 while the extension period is registered as NN5401-3645.


Options:
A: Inclusion Criteria:

* Informed consent, and child assent as age-appropriate, obtained before any trial-related activities (Trial-related activities are any procedure that would not have been performed during normal management of the subject). The parents or legal representative of the child must sign and date the Informed Consent Form according to local requirements. The child, if possible, parents or legal representative of the child must sign and date the Child Assent Form according to local requirements
* Male or female diagnosed with type 1 diabetes mellitus (T1DM) (based on clinical judgement and supported by laboratory analysis as per local guidelines)
* Ongoing daily treatment with insulin (any regimen) for at least 3 months prior to Visit 1 (screening). No OADs (oral anti-diabetic drugs) are allowed
* HbA1c (glycosylated haemoglobin) maximum 11%

Exclusion Criteria:

* Known or suspected hypersensitivity to trial product(s) or related products
* Previous participation in this trial. Participation is defined as randomisation
* Girls who are pregnant, breastfeeding or intend to become pregnant
* Girls who have had menarche and are not using adequate contraceptive measures according to local requirements
* Known hypoglycaemic unawareness or recurrent severe hypoglycaemic events as judged by the Investigator (trial physician)
* More than 1 diabetic ketoacidosis requiring hospitalisation within the last 3 months prior to Visit 1
* Significant concomitant disease, except for conditions associated with type 1 diabetes mellitus, which in the Investigator's opinion could interfere with the trial
* The receipt of any investigational drug within 1 month prior to Visit 1
B: 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
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 for 5 years.
* Age\>18 years.
* Two or more episodes of hypoglycaemia during the last year,

Exclusion Criteria:

* History of Addisons disease
* Growth hormone deficiency or untreated myxoedema
* CVD within 6 months
* Cancer within 5 years
* Alcohol or drug abuse
* Pregnant or lactating women
* Fertile women without effective contraception
* Participation in another trial within 30 days
* Inability to understand the informed consent

Answer: C