Impaired Glucose TolerancePhase 3NCT03725033

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

A Phase 3 study testing Subetta in people with Impaired Glucose Tolerance, run by Materia Medica Holding at 44 sites in Russia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Impaired Glucose Tolerance
What is being tested?: Subetta
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 538 participants
Where: 44 sitesRussia
Study dates: 10 Oct 2018to 23 Mar 2020
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

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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.
Pregnancy, breast-feeding; childbirth less than 3 months before enrollment.
Participation in other clinical trials for 3 months before enrollment in this study.
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).
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).

Trial locations and contacts

44 sites in 1 country.

City, postcode or hospital

44 sites in 1 country

Russia44 sites

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

Other trials in Russia

About this study

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

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.

Read the 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
Being tested: Subetta, Placebo
Medical subject headings: Glucose Intolerance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SubettaDrug
Oral administration.
PlaceboDrug
Oral administration.

Study groups in NCT03725033
Study group	Role	What they receive
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. Receives: 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. Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: At baseline and after 12 weeks of treatment.

Secondary outcomes (3)

Percentage of Patients With 2-hour Plasma Glucose <7.8 mmol / L.
Based on medical records.
Measured: 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.
Measured: 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.
Measured: At baseline and after 12 weeks of treatment.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Oct 201823 Mar 2020

First posted30 Oct 2018
Study start10 Oct 2018
Primary completion23 Mar 2020
Study completion23 Mar 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Impaired Glucose ToleranceStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 538 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03725033
Sponsor's protocol ID: MMH-SU-006
Status last verified: Nov 2019
First submitted: 29 Oct 2018
Last updated: 4 Feb 2021
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Impaired Glucose Tolerance trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT03725033
Acronym / sponsor ID: MMH-SU-006
Conditions: Impaired Glucose Tolerance
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 538 participants (actual)
Lead sponsor: Materia Medica HoldingIndustry (pharma, biotech, devices)
Study start: 10 Oct 2018 (actual)
Primary completion: 23 Mar 2020 (actual)
Study completion: 23 Mar 2020 (actual)
First posted: 30 Oct 2018 (actual)
Results: Posted 14 Jan 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Subetta	Experimental	Drug: SubettaTablet for oral use. 2 tablets twice daily. The tablets should be held in mouth until completely dissolved 15 min prior to meal.
Placebo	Placebo comparator	Drug: PlaceboTablet for oral use. 2 tablets twice daily. The tablets should be held in mouth until completely dissolved 15 min prior to meal.

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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).

Key exclusion criteria (19 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SubettaOral administration.	Drug	Subetta
PlaceboOral administration.	Drug	Placebo

Primary outcome

Change 2-hour Plasma Glucose (During Oral Glucose Tolerance Test).
Time frame: At baseline and after 12 weeks of treatment.
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.

3 secondary outcomes

Percentage of Patients With 2-hour Plasma Glucose <7.8 mmol / L.
Time frame: After 12 weeks of treatment.
Change in Fasting Plasma Glucose.
Time frame: At baseline and after 12 weeks of treatment.
Change in HbA1c
Time frame: At baseline and after 12 weeks of treatment.

Results and safety

Results posted to the registry on 14 Jan 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Subetta	105	105
Placebo	97	97

Primary outcome: Change 2-hour Plasma Glucose (During Oral Glucose Tolerance Test).

Time frame: At baseline and after 12 weeks of treatment.. Mean (Standard Deviation). Unit: mmol/L

Measure	Subetta n = 101	Placebo n = 92
Baseline	9.27 (0.88)	9.11 (0.86)
After 12 weeks	7.28 (2.07)	8.32 (2.44)
∆ between baseline and after 12 weeks	-1.99 (2.21)	-0.79 (2.55)

Subetta vs Placebo: p = 0.0028, Wilcoxon (Mann-Whitney)

Population analysed: 9 randomized patients who received full treatment and underwent all procedures according to the protocol (n = 4, Subetta group; n = 5, Placebo group) were excluded from analysis. Blood samples were obtained but the central laboratory did not provide carbohydrate metabolism values due to technical reasons for these patients.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: During the study - 12 weeks.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Subetta	0 of 105 (0%)	15 of 105 (14.3%)	0 of 105
Placebo	0 of 97 (0%)	20 of 97 (20.6%)	0 of 97

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

44 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Subetta in people with Impaired Glucose Tolerance, run by Materia Medica Holding at 44 sites in Russia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 44 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Jan 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change 2-hour Plasma Glucose (During Oral Glucose Tolerance Test). (time frame: At baseline and after 12 weeks of treatment.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03725033.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2021.