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

NCT ID: NCT03725033

Last Updated: 2021-02-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 538 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-10
• Study Completion Date: 2020-03-23

Brief 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.

Detailed Description

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".

Conditions

Impaired Glucose Tolerance

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Subetta

Tablet for oral use. 2 tablets twice daily. The tablets should be held in mouth until completely dissolved 15 min prior to meal.

Group Type: EXPERIMENTAL

Subetta

Intervention Type: DRUG

Oral administration.

Placebo

Tablet for oral use. 2 tablets twice daily. The tablets should be held in mouth until completely dissolved 15 min prior to meal.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Oral administration.

Interventions

Subetta

Oral administration.

Intervention Type: DRUG

Placebo

Oral administration.

Intervention Type: DRUG

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Materia Medica Holding

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Arkhangelsk Regional Clinical Hospital

Arkhangelsk, , Russia

Belgorod State National Research University

Belgorod, , Russia

Kirov Clinical Hospital № 7 named. V.I. Yurlova

Kirov, , Russia

Kuban State Medical University

Krasnodar, , Russia

Regional Clinical Hospital #1 named after Professor Ochapovsky

Krasnodar, , Russia

Clinic of Professor Gorbakov

Krasnogorsk, , Russia

Krasnogorsk city hospital №1

Krasnogorsk, , Russia

City Clinical Hospital named after F.I. Inozemtseva Department of Health of Moscow

Moscow, , Russia

City Clinical Hospital named after V.P. Demikhova

Moscow, , Russia

Moscow Clinical Scientific and Practical Center of the Moscow City Health Department

Moscow, , Russia

The Federal State Budgetary Healthcare Institution The Central Clinical Hospital of the Russian Academy of Sciences

Moscow, , Russia

Pirogov Russian National Research Medical University

Moscow, , Russia

Federal State Institution "Polyclinic No. 5" of the Administrative Department of the President of the Russian Federation

Moscow, , Russia

National Medical Research Center for Rehabilitation and Balneology

Moscow, , Russia

LLC Clinic "Bessalar"

Moscow, , Russia

Moscow State University of Medicine and Dentistry

Moscow, , Russia

City Clinical Hospital No. 10 of the Kanavinsky District of Nizhny Novgorod

Nizhny Novgorod, , Russia

Semashko Nizhny Novgorod Regional Clinical Hospital

Nizhny Novgorod, , Russia

LLC "Medical Center "Healthy Family"

Novosibirsk, , Russia

Institute of Cytology and Genetics of the Siberian Branch of the Russian Academy of Sciences

Novosibirsk, , Russia

Novosibirsk State Medical University

Novosibirsk, , Russia

Rostov State Medical University

Rostov-on-Don, , Russia

Polyclinic Complex JSC

Saint Petersburg, , Russia

City Clinical Hospital #109

Saint Petersburg, , Russia

St. Petersburg State Budgetary Healthcare Institution "City Polyclinic No. 25"

Saint Petersburg, , Russia

Federal State Budget Military Educational Institution of Higher Education "Military Medical Academy named after S.M. Kirov Defense Ministry of the RF/Department and clinic of field therapy

Saint Petersburg, , Russia

St. Petersburg State Budgetary Healthcare Institution "City Polyclinic No. 117"

Saint Petersburg, , Russia

St. Petersburg State Budgetary Institution of Health "City Polyclinic № 54"

Saint Petersburg, , Russia

Road Clinical Hospital JSC Russian Railways

Saint Petersburg, , Russia

Pavlov First Saint Petersburg State Medical University

Saint Petersburg, , Russia

Limited Liability Company Gastroenterologichesky Center Expert

Saint Petersburg, , Russia

St. Petersburg State Budgetary Institution of Health "City Polyclinic № 106"

Saint Petersburg, , Russia

Pokrovskaya City Hospital

Saint Petersburg, , Russia

St. Petersburg State Budgetary Institution of Health "City Polyclinic №4"

Saint Petersburg, , Russia

Samara city hospital #4

Samara, , Russia

LLC Center "Diabetes"

Samara, , Russia

Saratov State Medical University named after V. I. Razumovsky

Saratov, , Russia

Volgograd State Medical University

Volgograd, , Russia

Voronezh Regional Clinical Consultative and Diagnostic Center

Voronezh, , Russia

LLC "Medical Consultations and Research Center - PRACTICE"

Yaroslavl, , Russia

The State Budgetary Healthcare Institution of the Yaroslavl Region "Regional Clinical Hospital"

Yaroslavl, , Russia

Ural State Medical University

Yekaterinburg, , Russia

City Clinical Hospital #40

Yekaterinburg, , Russia

Central City Hospital #7

Yekaterinburg, , Russia

Countries

Russia

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

MMH-SU-006

Identifier Type: -

Identifier Source: org_study_id