Clinical Trial of Efficacy and Safety of Subetta in the Treatment of Impaired Glucose Tolerance
Condition: Impaired Glucose Tolerance
MeSH terms: Glucose Intolerance
Intervention: Subetta; Placebo
Intervention description: Oral administration.; Oral administration.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 538.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      Purpose of the study:

        -  to assess the efficacy of Subetta in the treatment of impaired glucose tolerance

        -  to assess the safety of Subetta in the treatment of impaired glucose tolerance.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Outpatients aged 18 to 70 years.

          2. Impaired glucose tolerance (plasma glucose from 7.8 to 11.0 mmol / L 2 hours after a
             75 g oral glucose consumption during an oral glucose tolerance test, while fasting
             plasma glucose <7.0 mmol / L).

          3. HbA1c is 5.7-6.4%.

          4. The body mass index is 25.0-39.9 kg / m^2.

          5. Consent to use reliable contraceptive methods during the study (for men and women with
             reproductive potential).

          6. The presence of the signed informed consent form to participate in the clinical trial.

        Exclusion Criteria:

          1. Type 1 or type 2 diabetes.

          2. Use of any medications indicated in the section "Prohibited concomitant medications".

          3. Acute or exacerbation / decompensation of a chronic disease of any etiology at the
             time of the examination or during the previous week.

          4. Uncontrolled arterial hypertension with blood pressure: systolic blood pressure > 160
             mm Hg and/or diastolic blood pressure > 110 mm Hg.

          5. Acute coronary syndrome, myocardial infarction, acute impairment of cerebral
             circulation during the previous 6 months prior to enrollment.

          6. Unstable or life-threatening arrhythmia during the previous 3 months prior to
             enrollment.

          7. Acute and chronic heart failure with functional class III or IV (according to the
             classification of the New York Heart Association, 1964).

          8. Respiratory failure.

          9. Chronic kidney disease (classes C3-5 A3).

         10. Hepatic insufficiency (class C according to Child-Pugh).

         11. Presence or suspicion of oncology disease.

         12. The presence of an allergy / hypersensitivity to any component of the medication
             administered during the treatment.

         13. Alcohol consumption > 2 alcohol units for males and > 1 alcohol unit for females per
             day.

         14. Mental illness or drug abuse in anamnesis.

         15. Bariatric surgery in anamnesis, any surgery for 3 months before enrollment.

         16. Pregnancy, breast-feeding; childbirth less than 3 months before enrollment.

         17. Participation in other clinical trials for 3 months before enrollment in this study.

         18. Patients who are related to any of the on-site research personnel directly involved in
             the conduct of the trial or are an immediate relative of the study investigator.
             'Immediate relative' means husband, wife, parent, son, daughter, brother, or sister
             (regardless of whether they are natural or adopted).

         19. Patients who work for MATERIA MEDICA HOLDING (i.e. the company's employees, temporary
             contract workers, appointed officials responsible for carrying out the research or
             immediate relatives of the aforementioned).