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

Impaired Glucose Tolerance Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03725033
• Other study ID #: MMH-SU-006
• Status: Completed
• Phase: Phase 3
• Start date: October 10, 2018
• Est. completion date: March 23, 2020

Study information

• Verified date: November 2019
• Source: Materia Medica Holding
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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".

Recruitment information / eligibility

• Status: Completed
• Enrollment: 538
• Est. completion date: March 23, 2020
• Est. primary completion date: March 23, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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).

Related Conditions & MeSH terms

• Glucose Intolerance
• Impaired Glucose Tolerance

Intervention

Drug:
• Subetta
Oral administration.
• Placebo
Oral administration.

Locations

Country	Name	City	State
Russian Federation	Arkhangelsk Regional Clinical Hospital	Arkhangelsk
Russian Federation	Belgorod State National Research University	Belgorod
Russian Federation	Central City Hospital #7	Ekaterinburg
Russian Federation	City Clinical Hospital #40	Ekaterinburg
Russian Federation	Ural State Medical University	Ekaterinburg
Russian Federation	Kirov Clinical Hospital ? 7 named. V.I. Yurlova	Kirov
Russian Federation	Kuban State Medical University	Krasnodar
Russian Federation	Regional Clinical Hospital #1 named after Professor Ochapovsky	Krasnodar
Russian Federation	Clinic of Professor Gorbakov	Krasnogorsk
Russian Federation	Krasnogorsk city hospital ?1	Krasnogorsk
Russian Federation	City Clinical Hospital named after F.I. Inozemtseva Department of Health of Moscow	Moscow
Russian Federation	City Clinical Hospital named after V.P. Demikhova	Moscow
Russian Federation	Federal State Institution "Polyclinic No. 5" of the Administrative Department of the President of the Russian Federation	Moscow
Russian Federation	LLC Clinic "Bessalar"	Moscow
Russian Federation	Moscow Clinical Scientific and Practical Center of the Moscow City Health Department	Moscow
Russian Federation	Moscow State University of Medicine and Dentistry	Moscow
Russian Federation	National Medical Research Center for Rehabilitation and Balneology	Moscow
Russian Federation	Pirogov Russian National Research Medical University	Moscow
Russian Federation	The Federal State Budgetary Healthcare Institution The Central Clinical Hospital of the Russian Academy of Sciences	Moscow
Russian Federation	City Clinical Hospital No. 10 of the Kanavinsky District of Nizhny Novgorod	Nizhny Novgorod
Russian Federation	Semashko Nizhny Novgorod Regional Clinical Hospital	Nizhny Novgorod
Russian Federation	Institute of Cytology and Genetics of the Siberian Branch of the Russian Academy of Sciences	Novosibirsk
Russian Federation	LLC "Medical Center "Healthy Family"	Novosibirsk
Russian Federation	Novosibirsk State Medical University	Novosibirsk
Russian Federation	Rostov State Medical University	Rostov-on-Don
Russian Federation	City Clinical Hospital #109	Saint Petersburg
Russian Federation	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	Limited Liability Company Gastroenterologichesky Center Expert	Saint Petersburg
Russian Federation	Pavlov First Saint Petersburg State Medical University	Saint Petersburg
Russian Federation	Pokrovskaya City Hospital	Saint Petersburg
Russian Federation	Polyclinic Complex JSC	Saint Petersburg
Russian Federation	Road Clinical Hospital JSC Russian Railways	Saint Petersburg
Russian Federation	St. Petersburg State Budgetary Healthcare Institution "City Polyclinic No. 117"	Saint Petersburg
Russian Federation	St. Petersburg State Budgetary Healthcare Institution "City Polyclinic No. 25"	Saint Petersburg
Russian Federation	St. Petersburg State Budgetary Institution of Health "City Polyclinic ? 106"	Saint Petersburg
Russian Federation	St. Petersburg State Budgetary Institution of Health "City Polyclinic ? 54"	Saint Petersburg
Russian Federation	St. Petersburg State Budgetary Institution of Health "City Polyclinic ?4"	Saint Petersburg
Russian Federation	LLC Center "Diabetes"	Samara
Russian Federation	Samara city hospital #4	Samara
Russian Federation	Saratov State Medical University named after V. I. Razumovsky	Saratov
Russian Federation	Volgograd State Medical University	Volgograd
Russian Federation	Voronezh Regional Clinical Consultative and Diagnostic Center	Voronezh
Russian Federation	LLC "Medical Consultations and Research Center - PRACTICE"	Yaroslavl
Russian Federation	The State Budgetary Healthcare Institution of the Yaroslavl Region "Regional Clinical Hospital"	Yaroslavl

Sponsors (1)

Lead Sponsor	Collaborator
Materia Medica Holding

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Percentage of Patients With 2-hour Plasma Glucose <7.8 mmol / L.	Based on medical records.	After 12 weeks of treatment.
Secondary	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.
Secondary	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.