Clinical Trial of Efficacy and Safety of Subetta in the Treatment of Impaired Glucose Tolerance

Study Overview
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Brief Summary
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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.

Detailed Description
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Design: a multicenter, double-blind, placebo-controlled, parallel-group randomized trial. The study will enroll outpatients adults aged 18 to 70 years with impaired glucose tolerance (IGT) who did not receive glucose-lowering agents previously. Persons with pre-diabetes, obesity (especially with visceral or abdominal obesity), dyslipidemia (with high triglycerides and/or low-density lipoproteins), hypertension, diabetes in first-degree relatives will be considered as potential candidates to participate in the study. After the patient's information sheet and the form of informed consent for participation in the study are signed on the screening (visit 0; day from -7 to 0), complaints and history are collected, registration of concomitant conditions and diseases, objective examination, calculation of body mass index (BMI), oral glucose tolerance test (OGTT), fasting blood glucose. Furthermore, blood samples (for testing HbA1c, chemistry and hematology, HLA genotyping) and urine sample will be collected; concomitant therapy will be recorded, diet and physical activity recommendations will be given. All women of childbearing potential will be administered pregnancy tests. If eligibility criteria are met and there are no non-inclusion criteria on Visit 1 (Day 1), the patient is randomized to one of two groups: the Subetta group (patients will take 2 tablets twice a day for 12 weeks) or placebo group (patients will take a placebo according to the scheme of Subetta for 12 weeks). In the course of the study, two more visits in 4 (Visit 2) and 12 (Visit 3) weeks are planned, during these weeks complaints are recorded, a patient's examination is recorded, therapy compliance and safety are assessed. On Visit 3 OGTT, fasting blood glucose, blood samples (for HbA1c, chemistry and hematology) and urinalysis will be performed. The duration of observation period shall be up to 13 weeks. During the study the treatment for underlying conditions will be allowed with the exception of the drugs indicated in the section Prohibited concomitant therapy.

Official Title
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Multicentre Double-blind Placebo-controlled Parallel Group Randomized Clinical Trial of Efficacy and Safety of Subetta in the Treatment of Impaired Glucose Tolerance

Conditions
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Impaired Glucose Tolerance

Intervention / Treatment
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* Drug: Subetta
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Outpatients aged 18 to 70 years. 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). HbA1c is 5.7-6.4%. The body mass index is 25.0-39.9 kg / m^2. Consent to use reliable contraceptive methods during the study (for men and women with reproductive potential). The presence of the signed informed consent form to participate in the clinical trial. Exclusion Criteria: Type 1 or type 2 diabetes. Use of any medications indicated in the section Prohibited concomitant medications. Acute or exacerbation / decompensation of a chronic disease of any etiology at the time of the examination or during the previous week. Uncontrolled arterial hypertension with blood pressure: systolic blood pressure > 160 mm Hg and/or diastolic blood pressure > 110 mm Hg. Acute coronary syndrome, myocardial infarction, acute impairment of cerebral circulation during the previous 6 months prior to enrollment. Unstable or life-threatening arrhythmia during the previous 3 months prior to enrollment. Acute and chronic heart failure with functional class III or IV (according to the classification of the New York Heart Association, 1964). Respiratory failure. Chronic kidney disease (classes C3-5 A3). Hepatic insufficiency (class C according to Child-Pugh). Presence or suspicion of oncology disease. The presence of an allergy / hypersensitivity to any component of the medication administered during the treatment. Alcohol consumption > 2 alcohol units for males and > 1 alcohol unit for females per day. Mental illness or drug abuse in anamnesis. Bariatric surgery in anamnesis, any surgery for 3 months before enrollment. Pregnancy, breast-feeding; childbirth less than 3 months before enrollment. Participation in other clinical trials for 3 months before enrollment in this study. 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). 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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Subetta<br>Tablet for oral use. 2 tablets twice daily. The tablets should be held in mouth until completely dissolved 15 min prior to meal. | Drug: Subetta<br>* Oral administration.<br>|
| Placebo Comparator: Placebo<br>Tablet for oral use. 2 tablets twice daily. The tablets should be held in mouth until completely dissolved 15 min prior to meal. | Drug: Placebo<br>* Oral administration.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change 2-hour Plasma Glucose (During Oral Glucose Tolerance Test). | Based on medical records. For oral glucose tolerance test, the subject is given 75 g of oral glucose and blood sample is taken 2 hours later. All analysis will be done in a central laboratory. | At baseline and after 12 weeks of treatment. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Patients With 2-hour Plasma Glucose <7.8 mmol / L. | Based on medical records. | After 12 weeks of treatment. | 
| Change in Fasting Plasma Glucose. | Based on medical records. Fasting plasma glucose is measured after fasting or not eating anything for at least 8 hours. | At baseline and after 12 weeks of treatment. | 
| Change in HbA1c | Based on medical records. HbA1c is determined by the method certified in accordance with National Glycohemoglobin Standardization Program and standardized in compliance with the reference values adopted in the Diabetes Control and Complications Trial. | At baseline and after 12 weeks of treatment. |