Clinical trial NCT03725033: Clinical Trial of Efficacy and Safety of Subetta in the Treatment of Impaired Glucose Tolerance
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Impaired Glucose Tolerance
Lead sponsor: Materia Medica Holding
Sponsor class: INDUSTRY
First posted: 2018-10-30
Enrollment: 538
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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".

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).

Primary outcomes:
measure: Change 2-hour Plasma Glucose (During Oral Glucose Tolerance Test).
timeFrame: At baseline and after 12 weeks of treatment.
Secondary outcomes:
measure: Percentage of Patients With 2-hour Plasma Glucose <7.8 mmol / L.
timeFrame: After 12 weeks of treatment.
measure: Change in Fasting Plasma Glucose.
timeFrame: At baseline and after 12 weeks of treatment.
measure: Change in HbA1c
timeFrame: At baseline and after 12 weeks of treatment.
Other outcomes:
Locations:
city: Arkhangelsk
country: Russian Federation
facility: Arkhangelsk Regional Clinical Hospital
city: Belgorod
country: Russian Federation
facility: Belgorod State National Research University
city: Ekaterinburg
country: Russian Federation
facility: Ural State Medical University
city: Ekaterinburg
country: Russian Federation
facility: City Clinical Hospital #40
city: Ekaterinburg
country: Russian Federation
facility: Central City Hospital #7
city: Kirov
country: Russian Federation
facility: Kirov Clinical Hospital № 7 named. V.I. Yurlova
city: Krasnodar
country: Russian Federation
facility: Kuban State Medical University
city: Krasnodar
country: Russian Federation
facility: Regional Clinical Hospital #1 named after Professor Ochapovsky
city: Krasnogorsk
country: Russian Federation
facility: Clinic of Professor Gorbakov
city: Krasnogorsk
country: Russian Federation
facility: Krasnogorsk city hospital №1
city: Moscow
country: Russian Federation
facility: City Clinical Hospital named after F.I. Inozemtseva Department of Health of Moscow
city: Moscow
country: Russian Federation
facility: City Clinical Hospital named after V.P. Demikhova
city: Moscow
country: Russian Federation
facility: Moscow Clinical Scientific and Practical Center of the Moscow City Health Department
city: Moscow
country: Russian Federation
facility: The Federal State Budgetary Healthcare Institution The Central Clinical Hospital of the Russian Academy of Sciences
city: Moscow
country: Russian Federation
facility: Pirogov Russian National Research Medical University
city: Moscow
country: Russian Federation
facility: Federal State Institution "Polyclinic No. 5" of the Administrative Department of the President of the Russian Federation
city: Moscow
country: Russian Federation
facility: National Medical Research Center for Rehabilitation and Balneology
city: Moscow
country: Russian Federation
facility: LLC Clinic "Bessalar"
city: Moscow
country: Russian Federation
facility: Moscow State University of Medicine and Dentistry
city: Nizhny Novgorod
country: Russian Federation
facility: City Clinical Hospital No. 10 of the Kanavinsky District of Nizhny Novgorod
city: Nizhny Novgorod
country: Russian Federation
facility: Semashko Nizhny Novgorod Regional Clinical Hospital
city: Novosibirsk
country: Russian Federation
facility: LLC "Medical Center "Healthy Family"
city: Novosibirsk
country: Russian Federation
facility: Institute of Cytology and Genetics of the Siberian Branch of the Russian Academy of Sciences
city: Novosibirsk
country: Russian Federation
facility: Novosibirsk State Medical University
city: Rostov-on-Don
country: Russian Federation
facility: Rostov State Medical University
city: Saint Petersburg
country: Russian Federation
facility: Polyclinic Complex JSC
city: Saint Petersburg
country: Russian Federation
facility: City Clinical Hospital #109
city: Saint Petersburg
country: Russian Federation
facility: St. Petersburg State Budgetary Healthcare Institution "City Polyclinic No. 25"
city: Saint Petersburg
country: Russian Federation
facility: 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
city: Saint Petersburg
country: Russian Federation
facility: St. Petersburg State Budgetary Healthcare Institution "City Polyclinic No. 117"
city: Saint Petersburg
country: Russian Federation
facility: St. Petersburg State Budgetary Institution of Health "City Polyclinic № 54"
city: Saint Petersburg
country: Russian Federation
facility: Road Clinical Hospital JSC Russian Railways
city: Saint Petersburg
country: Russian Federation
facility: Pavlov First Saint Petersburg State Medical University
city: Saint Petersburg
country: Russian Federation
facility: Limited Liability Company Gastroenterologichesky Center Expert
city: Saint Petersburg
country: Russian Federation
facility: St. Petersburg State Budgetary Institution of Health "City Polyclinic № 106"
city: Saint Petersburg
country: Russian Federation
facility: Pokrovskaya City Hospital
city: Saint Petersburg
country: Russian Federation
facility: St. Petersburg State Budgetary Institution of Health "City Polyclinic №4"
city: Samara
country: Russian Federation
facility: Samara city hospital #4
city: Samara
country: Russian Federation
facility: LLC Center "Diabetes"
city: Saratov
country: Russian Federation
facility: Saratov State Medical University named after V. I. Razumovsky
city: Volgograd
country: Russian Federation
facility: Volgograd State Medical University
city: Voronezh
country: Russian Federation
facility: Voronezh Regional Clinical Consultative and Diagnostic Center
city: Yaroslavl
country: Russian Federation
facility: LLC "Medical Consultations and Research Center - PRACTICE"
city: Yaroslavl
country: Russian Federation
facility: The State Budgetary Healthcare Institution of the Yaroslavl Region "Regional Clinical Hospital"
Study officials:
References: