Clinical trial NCT02631928 (phase 1, status: completed)
Conditions: diabetes mellitus
ICD codes: P70.2, O24.92, Z83.3, E10.65, E10.9, E11.65, E11.9
Drugs: human biphasic insulin, human biphasic insulin, reference
SMILES: [Na+].[Na+].[O-]P([O-])(F)=O
Eligibility criteria:

        Inclusion Criteria:

          -  Signed and dated informed consent obtained before any trial-related activities.
             (Trial-related activities are any procedures that would not have been performed during
             normal management of the subject).

          -  Healthy male subject.

          -  Age between 18 and 55 years, both inclusive.

          -  Body Mass Index (BMI) between 18.5 and 28.0 kg/m^2, both inclusive.

          -  Fasting plasma glucose concentration <= 100 mg/dL.

        Exclusion Criteria:

          -  Known or suspected hypersensitivity to IMPs or related products.

          -  Previous participation in this trial. Participation is defined as randomised.

          -  Receipt of any medicinal product in clinical development within 3 months before
             screening.

          -  Any history or presence of cancer except basal cell skin cancer or squamous cell skin
             cancer as judged by the Investigator.

          -  Any history or presence of clinically relevant cardiovascular, pulmonary, respiratory,
             gastrointestinal, hepatic, renal, metabolic, endocrinological haematological,
             dermatological, neurological, osteomuscular, articular, psychiatric, systemic, ocular,
             or infectious disease, or signs of acute illness as judged by the Investigator.

          -  Surgery within 12 weeks before the start of the study or blood donation of more than
             500 mL (or considerable blood loss) or plasma donation within the last 3 months.

          -  Increased risk of thrombosis, e.g., subjects with a history of deep leg vein
             thrombosis or family history of deep leg vein thrombosis, as judged by the
             Investigator.

          -  Clinically significant abnormal values for haematology, biochemistry, coagulation, or
             urinalysis as judged by the Investigator.

          -  Supine blood pressure (BP) at screening (after resting for 5 minutes in a supine
             position) outside the range of 90 to 140 mmHg for systolic BP or 50 to 90 mmHg for
             diastolic BP (excluding white-coat hypertension; therefore, if a repeated measurement
             shows values within the range, the subject can be included in the trial) and/or
             resting supine pulse < 50 beats per minute.

          -  Clinically significant abnormal standard 12-lead electrocardiogram (ECG) after 5
             minutes resting in supine position at screening, as judged by the Investigator.

          -  Any disease or condition that, in the opinion of the Investigator, would represent an
             unacceptable risk for the subject's safety.

          -  Positive to the screening test for Hepatitis Bs antigen or Hepatitis C antibodies
             and/or a positive result to the test for HIV-1/2 antibodies or HIV-1 antigen.

          -  History of multiple and/or severe allergies to drugs or foods or a history of severe
             anaphylactic reaction.

          -  Likelihood of requiring treatment during the study period with drugs not permitted by
             the clinical study protocol.

          -  Any medication (prescription and non-prescription drugs) within 14 days before first
             trial drug administration and/or anticoagulant therapy, with the exception of stable
             treatment with thyroid hormones, paracetamol and ibuprofen for occasional use to treat
             pain.

          -  Significant history of alcoholism or drug abuse as judged by the Investigator or
             consuming more than 21 units of alcohol per week (one unit of alcohol equals about 330
             mL of beer, one glass of wine of 120 mL, or 40 mL spirits).

          -  A positive result in the alcohol and/or urine drug screen at the screening visit.

          -  Smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent
             per day) who is not able or willing to refrain from smoking and use of nicotine
             substitute products 1 day before and during the inpatient period.

          -  Subject with mental incapacity or language barriers precluding adequate understanding
             or cooperation or who, in the opinion of the Investigator, should not participate in
             the trial.

          -  Potentially noncompliant or uncooperative during the trial, as judged by the
             Investigator.