Clinical Trial of Efficacy and Safety of Subetta in the Combined Treatment of Patients With Type I Diabetes Mellitus
Condition: Type I Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is:

        -  to assess clinical efficacy of Subetta in the combined treatment of type I diabetes
           mellitus;

        -  to assess safety of Subetta in the combined treatment of type I diabetes mellitus.
    

Detailed description: 
      Patients with type I diabetes mellitus are included in the trial. It is concerned those
      patients, who by the time of the trial receive basal bolus insulin therapy of type I diabetes
      mellitus, including basal insulin (using long acting medications) and prandial insulin (short
      and ultra short acting medications), and with poor glycemic control (HbA1c=7.0-10.0%). For
      patients, which will be included in the trial (mainly middle aged patients without severe
      complications of diabetes), HbA1c>7.0% is the marker showing that optimal individual goal of
      glycemic control is not achieved.

      HbA1c, fasting plasma glucose, microalbuminuria, estimated glomerular filtration rate,
      ophthalmoscopy, blood pressure measurement, patient self-monitoring of blood glucose,
      frequency of hypoglycemia, endocrinologist examination were performed within screening
      period. Patients without severe diabetes complications are randomized in 2 groups.

      If a patient meets inclusion criteria and does not show exclusion criteria he/she is
      randomized in one of 2 groups: Group 1 - patients receiving standard type I diabetes mellitus
      therapy + Subetta at a dose of 1 tablet 4 times a day; Group 2 - the group receiving standard
      type I diabetes mellitus therapy + Placebo under the regimen used for Subetta. The invented
      names of the drugs containing basal and prandial (meal) insulin should be unchanged for each
      patient during the whole trial.

      All patients will receive glucometers and the appropriate glucose test strips, so they could
      self monitor blood glucose and register this data in their diaries.

      The trial duration is 38 weeks; the main stages of the trial are conducted during screening,
      then in 4 weeks (Visit 2), in 12 weeks (Visit 3), in 24 weeks (Visit 4) and in 36 weeks
      (Visit 5). In 1 week after randomization and the onset of the trial therapy and between the
      visits to the study site (on weeks 8±1, 18±1 and 30±1) an investigator collects data on
      patient's health and complaints (phone visits) to decide whether it is necessary to arrange
      unplanned visit to the site.
    

Intervention name(s): Subetta; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Each Subetta tablet contains a mixture of affinity purified polyclonal antibodies to β-subunit of the rINS (6 mg) and antibodies to eNOS (6 mg) in released-active form produced by the patented technology in accordance with the applicable European Pharmacopeia requirements.
Standard therapy of type I diabetes mellitus + Subetta (1 tablet 4 times a day) for 36 weeks.
Subetta: oral administration, per 1 intake - 1 tablet (keep in the mouth until complete dissolution, not at mealtime).; Placebo (identical to Subetta in shape and taste tablet containing exсipients). Standard therapy of type I diabetes mellitus + Placebo (1 tablet 4 times a day) for 36 weeks.
Placebo: oral administration, per 1 intake - 1 tablet (keep in the mouth until complete dissolution, not at mealtime).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Combined treatment of patients with type I diabetes mellitus