Clinical trial NCT00542724 (phase 3, status: completed)
Conditions: type 1 diabetes mellitus
ICD codes: E10.65, E10.9, E10.21, E10.36, E10.41, E10.42, E10.44
Drugs: viaject™, regular human insulin
SMILES: [Na+].[Na+].[O-]P([O-])(F)=O
Eligibility criteria:

        Inclusion Criteria:

        Male or female patients with type 1 diabetes must present with the following:

          -  Established diagnosis of type 1 diabetes for more than 1 year.

          -  HbA1c values of not more than 10.5%.

          -  Three months on a stable insulin regimen that meets the current standard of care and
             that includes at least two daily insulin injections.

          -  Age: 18 to 70 years.

          -  Body Mass Index: 18 - 38 Kg/m2.

        Exclusion Criteria:

        Patients presenting with any of the following will not be included in the study:

          -  Type 2 diabetes mellitus as determined by the investigator.

          -  History of frequent severe hypoglycemia within the prior six months.

          -  C-peptide > 1.0 ng/ml unless there is a documented history of ketoacidosis or a
             documented history of a positive anti GAD test.

          -  History of known hypersensitivity to any of the components in the study medication.

          -  History of severe or multiple allergies.

          -  Treatment with investigational diabetes drug in the last 3 months or treatment with
             any other investigational drug in the last 30 days before study entry.

          -  Current short-term treatment with systemic oral, injected, or inhaled corticosteroids.
             (inhaled corticosteroids may be allowed when the treatment is long-term).

          -  Progressive disease likely to prove fatal.

          -  History of malignancy within the past 5 years except for basal cell epithelioma.

          -  Known significant hepatic disease or serum AST or ALT values ≥ 3 X upper limit of
             normal or bilirubin levels ≥ 1.5 X upper limit of normal.

          -  Severe complications of diabetes mellitus including a history or finding of Stage III
             or IV diabetic retinopathy, proteinuria > 2+ by urine dipstick, serum creatinine of
             >1.8 mg/dl for males or >1.5 mg/dl for females, history of renal transplant, severe
             peripheral vascular disease which has resulted in an amputation, chronic foot ulcers
             claudication or absent pedal pulses.

          -  Known history of autonomic neuropathy.

          -  History of moderate to severe ketoacidosis within the 3 months preceding screening for
             the study.

          -  Current drug or alcohol abuse, or a history which in the opinion of the Investigator
             will impair patient safety or protocol compliance.

          -  Current significant cardiovascular, respiratory, gastrointestinal, hepatic, renal,
             neurological, psychiatric and/or hematological disease as evaluated by the
             Investigator.

          -  Blood donation within the last 30 days.

          -  A woman who is breast feeding.

          -  Pregnant women or women intending to become pregnant during the study.

          -  A sexually active woman of childbearing age not actively and consistently practicing
             birth control by using a medically accepted device or therapy.

          -  Abnormal ECG, safety lab or physical examination results which, in the opinion of the
             investigator, render the participation of the patient in the study to be inappropriate
             or unsafe.

          -  A history of lack of compliance with medical instructions, recent drug or alcohol
             abuse, or other reasons which, in the opinion of the investigator, render the
             participation of the patient in the study to be inappropriate or unsafe.

          -  Current significant diseases of the adrenal gland, pituitary gland or thyroid at the
             discretion of the investigator.

          -  Glomerular Filtration Rate < 40 ml/min.