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

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

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.

Study Overview

• Status: Completed
• Conditions: Impaired Glucose Tolerance
• Intervention / Treatment: Drug: Placebo; Drug: Subetta

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".

• Study Type: Interventional
• Enrollment (Actual): 538
• Phase: Phase 3

Contacts and Locations

Study Locations

• Russian Federation
  • Arkhangelsk, Russian Federation, 163045
    • Arkhangelsk Regional Clinical Hospital
  • Belgorod, Russian Federation, 308015
    • Belgorod State National Research University
  • Ekaterinburg, Russian Federation, 620026
    • Ural State Medical University
  • Ekaterinburg, Russian Federation, 620102
    • City Clinical Hospital #40
  • Ekaterinburg, Russian Federation, 620137
    • Central City Hospital #7
  • Kirov, Russian Federation, 610014
    • Kirov Clinical Hospital № 7 named. V.I. Yurlova
  • Krasnodar, Russian Federation, 350063
    • Kuban State Medical University
  • Krasnodar, Russian Federation, 350086
    • Regional Clinical Hospital #1 named after Professor Ochapovsky
  • Krasnogorsk, Russian Federation, 143405
    • Clinic of Professor Gorbakov
  • Krasnogorsk, Russian Federation, 143408
    • Krasnogorsk city hospital №1
  • Moscow, Russian Federation, 117997
    • Pirogov Russian National Research Medical University
  • Moscow, Russian Federation, 127473
    • Moscow State University of Medicine and Dentistry
  • Moscow, Russian Federation, 117593
    • The Federal State Budgetary Healthcare Institution The Central Clinical Hospital of the Russian Academy of Sciences
  • Moscow, Russian Federation, 105187
    • City Clinical Hospital named after F.I. Inozemtseva Department of Health of Moscow
  • Moscow, Russian Federation, 109263
    • City Clinical Hospital named after V.P. Demikhova
  • Moscow, Russian Federation, 111123
    • Moscow Clinical Scientific and Practical Center of the Moscow City Health Department
  • Moscow, Russian Federation, 119121
    • Federal State Institution "Polyclinic No. 5" of the Administrative Department of the President of the Russian Federation
  • Moscow, Russian Federation, 121099
    • National Medical Research Center for Rehabilitation and Balneology
  • Moscow, Russian Federation, 123423
    • LLC Clinic "Bessalar"
  • Nizhny Novgorod, Russian Federation, 603011
    • City Clinical Hospital No. 10 of the Kanavinsky District of Nizhny Novgorod
  • Nizhny Novgorod, Russian Federation, 603126
    • Semashko Nizhny Novgorod Regional Clinical Hospital
  • Novosibirsk, Russian Federation, 630091
    • Novosibirsk State Medical University
  • Novosibirsk, Russian Federation, 630061
    • LLC "Medical Center "Healthy Family"
  • Novosibirsk, Russian Federation, 630090
    • Institute of Cytology and Genetics of the Siberian Branch of the Russian Academy of Sciences
  • Rostov-on-Don, Russian Federation, 344022
    • Rostov State Medical University
  • Saint Petersburg, Russian Federation, 197022
    • Pavlov First Saint Petersburg State Medical University
  • Saint Petersburg, Russian Federation, 197110
    • Limited Liability Company Gastroenterologichesky Center Expert
  • Saint Petersburg, Russian Federation, 194358
    • St. Petersburg State Budgetary Healthcare Institution "City Polyclinic No. 117"
  • Saint Petersburg, Russian Federation, 190013
    • Polyclinic Complex JSC
  • Saint Petersburg, Russian Federation, 192283
    • City Clinical Hospital #109
  • Saint Petersburg, Russian Federation, 193312
    • St. Petersburg State Budgetary Healthcare Institution "City Polyclinic No. 25"
  • Saint Petersburg, Russian Federation, 194044
    • 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, Russian Federation, 195197
    • St. Petersburg State Budgetary Institution of Health "City Polyclinic № 54"
  • Saint Petersburg, Russian Federation, 195271
    • Road Clinical Hospital JSC Russian Railways
  • Saint Petersburg, Russian Federation, 198328
    • St. Petersburg State Budgetary Institution of Health "City Polyclinic № 106"
  • Saint Petersburg, Russian Federation, 199106
    • Pokrovskaya City Hospital
  • Saint Petersburg, Russian Federation, 199178
    • St. Petersburg State Budgetary Institution of Health "City Polyclinic №4"
  • Samara, Russian Federation, 443056
    • Samara city hospital #4
  • Samara, Russian Federation, 443067
    • LLC Center "Diabetes"
  • Saratov, Russian Federation, 410054
    • Saratov State Medical University named after V. I. Razumovsky
  • Volgograd, Russian Federation, 400131
    • Volgograd State Medical University
  • Voronezh, Russian Federation, 394018
    • Voronezh Regional Clinical Consultative and Diagnostic Center
  • Yaroslavl, Russian Federation, 150003
    • LLC "Medical Consultations and Research Center - PRACTICE"
  • Yaroslavl, Russian Federation, 150062
    • The State Budgetary Healthcare Institution of the Yaroslavl Region "Regional Clinical Hospital"

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Subetta; 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; Oral administration.
Placebo Comparator: Placebo; 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; Oral administration.

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Materia Medica Holding

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2018
• Primary Completion (Actual): March 23, 2020
• Study Completion (Actual): March 23, 2020

Study Registration Dates

• First Submitted: October 29, 2018
• First Submitted That Met QC Criteria: October 29, 2018
• First Posted (Actual): October 30, 2018

Study Record Updates

• Last Update Posted (Actual): February 4, 2021
• Last Update Submitted That Met QC Criteria: January 14, 2021
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Hyperglycemia; Glucose Intolerance
• Other Study ID Numbers: MMH-SU-006

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No