Please select the eligibility criteria that correspond to the clinical trial below.
Title: The Effect of Insulin Analogues and Human Insulin on the Incidence of Severe Hypoglycaemia in Hypoglycaemia Prone Type 1 Diabetic Patients
Brief Summary: Severe hypoglycaemia is hampering the lives of many diabetic patients. The effect on the occurrence of severe hypoglycaemia during two different insulin regimens are to be investigated. In total, 250 hypoglycaemia prone type 1 diabetic patients will be randomised to receive analogue and human insulin for one year in random order. Outcomes will be number of episodes of severe hypoglycaemia


Options:
A: 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
B: Eligibility Criteria:

* The major criteria for eligibility included insulin dependence, as evidenced by deficient C-peptide secretion; an age of 13 to 39 years; and the absence of hypertension, hypercholesterolemia, and severe diabetic complications or medical conditions. To be eligible for the primary-prevention cohort, patients were required to have had insulin dependent diabetes mellitus (IDDM) for one to five years, to have no retinopathy as detected by seven-field stereoscopic fundus photography, and to have urinary albumin excretion of less than 40 mg per 24 hours. To be eligible for the secondary-intervention cohort, the patients were required to have IDDM for 1 to 15 years, to have very-mild to moderate nonproliferative retinopathy, and to have urinary albumin excretion of less than 200 mg per 24 hours.
C: 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
D: 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

Answer: C