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

NCT03725033 | Completed Phase 3 Results

• 1 other identifier: MMH-SU-006
• Study Type: interventional
• Target: 538
• Locations: 1 country
• Sites: 44

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.

Conditions

Impaired Glucose Tolerance

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Percentage of Patients With 2-hour Plasma Glucose <7.8 mmol / L.

  After 12 weeks of treatment.

• Change in Fasting Plasma Glucose.

  At baseline and after 12 weeks of treatment.

• Change in HbA1c

  At baseline and after 12 weeks of treatment.

Study Arms (2)

Subetta

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

Subetta DRUG

Oral administration.

Subetta

Placebo DRUG

Oral administration.

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Materia Medica Holding: lead

Study Sites (44)

Arkhangelsk Regional Clinical Hospital

Arkhangelsk, 163045, Russia

Location

Belgorod State National Research University

Belgorod, 308015, Russia

Location

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

Kirov, 610014, Russia

Location

Kuban State Medical University

Krasnodar, 350063, Russia

Location

Regional Clinical Hospital #1 named after Professor Ochapovsky

Krasnodar, 350086, Russia

Location

Clinic of Professor Gorbakov

Krasnogorsk, 143405, Russia

Location

Krasnogorsk city hospital №1

Krasnogorsk, 143408, Russia

Location

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

Moscow, 105187, Russia

Location

City Clinical Hospital named after V.P. Demikhova

Moscow, 109263, Russia

Location

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

Moscow, 111123, Russia

Location

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

Moscow, 117593, Russia

Location

Pirogov Russian National Research Medical University

Moscow, 117997, Russia

Location

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

Moscow, 119121, Russia

Location

National Medical Research Center for Rehabilitation and Balneology

Moscow, 121099, Russia

Location

LLC Clinic "Bessalar"

Moscow, 123423, Russia

Location

Moscow State University of Medicine and Dentistry

Moscow, 127473, Russia

Location

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

Nizhny Novgorod, 603011, Russia

Location

Semashko Nizhny Novgorod Regional Clinical Hospital

Nizhny Novgorod, 603126, Russia

Location

LLC "Medical Center "Healthy Family"

Novosibirsk, 630061, Russia

Location

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

Novosibirsk, 630090, Russia

Location

Novosibirsk State Medical University

Novosibirsk, 630091, Russia

Location

Rostov State Medical University

Rostov-on-Don, 344022, Russia

Location

Polyclinic Complex JSC

Saint Petersburg, 190013, Russia

Location

City Clinical Hospital #109

Saint Petersburg, 192283, Russia

Location

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

Saint Petersburg, 193312, Russia

Location

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, 194044, Russia

Location

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

Saint Petersburg, 194358, Russia

Location

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

Saint Petersburg, 195197, Russia

Location

Road Clinical Hospital JSC Russian Railways

Saint Petersburg, 195271, Russia

Location

Pavlov First Saint Petersburg State Medical University

Saint Petersburg, 197022, Russia

Location

Limited Liability Company Gastroenterologichesky Center Expert

Saint Petersburg, 197110, Russia

Location

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

Saint Petersburg, 198328, Russia

Location

Pokrovskaya City Hospital

Saint Petersburg, 199106, Russia

Location

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

Saint Petersburg, 199178, Russia

Location

Samara city hospital #4

Samara, 443056, Russia

Location

LLC Center "Diabetes"

Samara, 443067, Russia

Location

Saratov State Medical University named after V. I. Razumovsky

Saratov, 410054, Russia

Location

Volgograd State Medical University

Volgograd, 400131, Russia

Location

Voronezh Regional Clinical Consultative and Diagnostic Center

Voronezh, 394018, Russia

Location

LLC "Medical Consultations and Research Center - PRACTICE"

Yaroslavl, 150003, Russia

Location

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

Yaroslavl, 150062, Russia

Location

Ural State Medical University

Yekaterinburg, 620026, Russia

Location

City Clinical Hospital #40

Yekaterinburg, 620102, Russia

Location

Central City Hospital #7

Yekaterinburg, 620137, Russia

Location

MeSH Terms

Conditions

Glucose Intolerance

Interventions

subetta

Condition Hierarchy (Ancestors)

Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Results Point of Contact

• Title: Mikhail Putilovskiy, MD, PhD, Clinical and Medical Department Director
• Organization: MATERIA MEDICA HOLDING

PutilovskiyMA@materiamedica.ru

+74952761571

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2018
• First Posted: October 30, 2018
• Study Start: October 10, 2018
• Primary Completion: March 23, 2020
• Study Completion: March 23, 2020
• Last Updated: February 4, 2021
• Results First Posted: January 14, 2021

Record last verified: 2019-11

Locations

RU (44)