Clinical Trial of Efficacy and Safety of Subetta in the Combined Treatment of Patients With Type II Diabetes Mellitus
Condition: Type II Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
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 II diabetes
           mellitus;

        -  to assess safety of Subetta in the combined treatment of type II diabetes mellitus.
    

Detailed description: 
      Patients with type II diabetes mellitus are included in the trial. It is concerned those
      patients, who by the time of the trial receive basal insulin with metformin or metformin and
      sulfonylurea derivatives and with lack of optimal glycemic control (HbA1c>7.0%). 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.

      If a patient meets inclusion criteria and does not show exclusion criteria he/she is
      randomized in one of 2 groups: Group 1 - the group receiving standard type II diabetes
      mellitus therapy + Subetta at a dose of 1 tablet 4 times a day; Group 2 - the group receiving
      standard type II diabetes mellitus therapy + Placebo under the regimen used for Subetta. The
      invented names of the drugs containing basal insulin, metformin and sulfonylurea derivatives
      used as standard type II diabetes mellitus therapy, 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±1and 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 II 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 II 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 II Diabetes Mellitus