Trial Outcomes & Findings for Clinical Trial of Efficacy and Safety of Subetta in the Treatment of Impaired Glucose Tolerance (NCT NCT03725033)
NCT ID: NCT03725033
Last Updated: 2021-02-04
Results Overview
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.
COMPLETED
PHASE3
538 participants
At baseline and after 12 weeks of treatment.
2021-02-04
Participant Flow
After screening procedures 336 patients were excluded by the researchers because they did not meet the inclusion criteria, or they had non-inclusion criteria.
Participant milestones
| Measure |
Subetta
Tablet for oral use. 2 tablets twice daily. The tablets should be held in mouth until completely dissolved 15 min prior to meal.
|
Placebo
Tablet for oral use. 2 tablets twice daily. The tablets should be held in mouth until completely dissolved 15 min prior to meal.
|
|---|---|---|
|
Overall Study
STARTED
|
105
|
97
|
|
Overall Study
COMPLETED
|
105
|
97
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Subetta
n=105 Participants
Oral administration. 2 tablets 2 times a day 15 minutes before meals. Keep the tablets in your mouth, not swallowing, until completely they are dissolved.
Subetta: For oral use.
|
Placebo
n=97 Participants
Oral administration. 2 tablets 2 times a day 15 minutes before meals. Keep the tablets in your mouth, not swallowing, until completely they are dissolved.
Placebo: For oral use.
|
Total
n=202 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56.6 years
STANDARD_DEVIATION 9.3 • n=105 Participants
|
56.1 years
STANDARD_DEVIATION 8.6 • n=97 Participants
|
56.4 years
STANDARD_DEVIATION 9.0 • n=202 Participants
|
|
Sex: Female, Male
Female
|
78 Participants
n=105 Participants
|
75 Participants
n=97 Participants
|
153 Participants
n=202 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=105 Participants
|
22 Participants
n=97 Participants
|
49 Participants
n=202 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Russia
|
105 participants
n=105 Participants
|
97 participants
n=97 Participants
|
202 participants
n=202 Participants
|
PRIMARY outcome
Timeframe: At baseline and after 12 weeks of treatment.Population: 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.
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.
Outcome measures
| Measure |
Subetta
n=101 Participants
Tablet for oral use. 2 tablets twice daily. The tablets should be held in mouth until completely dissolved 15 min prior to meal.
Subetta: Oral administration.
|
Placebo
n=92 Participants
Tablet for oral use. 2 tablets twice daily. The tablets should be held in mouth until completely dissolved 15 min prior to meal.
Placebo: Oral administration.
|
|---|---|---|
|
Change 2-hour Plasma Glucose (During Oral Glucose Tolerance Test).
After 12 weeks
|
7.28 mmol/L
Standard Deviation 2.07
|
8.32 mmol/L
Standard Deviation 2.44
|
|
Change 2-hour Plasma Glucose (During Oral Glucose Tolerance Test).
∆ between baseline and after 12 weeks
|
-1.99 mmol/L
Standard Deviation 2.21
|
-0.79 mmol/L
Standard Deviation 2.55
|
|
Change 2-hour Plasma Glucose (During Oral Glucose Tolerance Test).
Baseline
|
9.27 mmol/L
Standard Deviation 0.88
|
9.11 mmol/L
Standard Deviation 0.86
|
SECONDARY outcome
Timeframe: After 12 weeks of treatment.Population: 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.
Based on medical records.
Outcome measures
| Measure |
Subetta
n=101 Participants
Tablet for oral use. 2 tablets twice daily. The tablets should be held in mouth until completely dissolved 15 min prior to meal.
Subetta: Oral administration.
|
Placebo
n=92 Participants
Tablet for oral use. 2 tablets twice daily. The tablets should be held in mouth until completely dissolved 15 min prior to meal.
Placebo: Oral administration.
|
|---|---|---|
|
Percentage of Patients With 2-hour Plasma Glucose <7.8 mmol / L.
|
64 Participants
|
46 Participants
|
SECONDARY outcome
Timeframe: At baseline and after 12 weeks of treatment.Population: 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.
Based on medical records. Fasting plasma glucose is measured after fasting or not eating anything for at least 8 hours.
Outcome measures
| Measure |
Subetta
n=101 Participants
Tablet for oral use. 2 tablets twice daily. The tablets should be held in mouth until completely dissolved 15 min prior to meal.
Subetta: Oral administration.
|
Placebo
n=92 Participants
Tablet for oral use. 2 tablets twice daily. The tablets should be held in mouth until completely dissolved 15 min prior to meal.
Placebo: Oral administration.
|
|---|---|---|
|
Change in Fasting Plasma Glucose.
Baseline
|
5.83 mmol/L
Standard Deviation 0.62
|
5.88 mmol/L
Standard Deviation 0.60
|
|
Change in Fasting Plasma Glucose.
After 12 weeks
|
6.01 mmol/L
Standard Deviation 1.17
|
6.02 mmol/L
Standard Deviation 0.92
|
|
Change in Fasting Plasma Glucose.
∆ between baseline and after 12 weeks
|
0.18 mmol/L
Standard Deviation 1.25
|
0.14 mmol/L
Standard Deviation 1.06
|
SECONDARY outcome
Timeframe: At baseline and after 12 weeks of treatment.Population: 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.
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.
Outcome measures
| Measure |
Subetta
n=101 Participants
Tablet for oral use. 2 tablets twice daily. The tablets should be held in mouth until completely dissolved 15 min prior to meal.
Subetta: Oral administration.
|
Placebo
n=92 Participants
Tablet for oral use. 2 tablets twice daily. The tablets should be held in mouth until completely dissolved 15 min prior to meal.
Placebo: Oral administration.
|
|---|---|---|
|
Change in HbA1c
Baseline
|
5.9 percentage of HbA1c
Interval 5.8 to 6.1
|
6.0 percentage of HbA1c
Interval 5.85 to 6.2
|
|
Change in HbA1c
After 12 weeks
|
5.8 percentage of HbA1c
Interval 5.5 to 6.0
|
5.9 percentage of HbA1c
Interval 5.6 to 6.05
|
|
Change in HbA1c
∆ between baseline and after 12 weeks
|
-0.1 percentage of HbA1c
Interval -0.5 to -0.1
|
-0.1 percentage of HbA1c
Interval -0.4 to -0.1
|
Adverse Events
Subetta
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Subetta
n=105 participants at risk
Tablet for oral use. 2 tablets twice daily. The tablets should be held in mouth until completely dissolved 15 min prior to meal.
|
Placebo
n=97 participants at risk
Tablet for oral use. 2 tablets twice daily. The tablets should be held in mouth until completely dissolved 15 min prior to meal.
|
|---|---|---|
|
Gastrointestinal disorders
Pain in the abdomen
|
0.00%
0/105 • During the study - 12 weeks.
|
1.0%
1/97 • Number of events 1 • During the study - 12 weeks.
|
|
Gastrointestinal disorders
Epigastric pain
|
0.00%
0/105 • During the study - 12 weeks.
|
1.0%
1/97 • Number of events 1 • During the study - 12 weeks.
|
|
Gastrointestinal disorders
Vomiting
|
0.95%
1/105 • Number of events 1 • During the study - 12 weeks.
|
1.0%
1/97 • Number of events 1 • During the study - 12 weeks.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/105 • During the study - 12 weeks.
|
1.0%
1/97 • Number of events 1 • During the study - 12 weeks.
|
|
Infections and infestations
Acute respiratory tract infection
|
0.95%
1/105 • Number of events 1 • During the study - 12 weeks.
|
3.1%
3/97 • Number of events 3 • During the study - 12 weeks.
|
|
Infections and infestations
Acute bronchitis
|
0.00%
0/105 • During the study - 12 weeks.
|
1.0%
1/97 • Number of events 1 • During the study - 12 weeks.
|
|
Infections and infestations
Acute conjunctivitis
|
0.95%
1/105 • Number of events 1 • During the study - 12 weeks.
|
0.00%
0/97 • During the study - 12 weeks.
|
|
Infections and infestations
Acute cystitis
|
0.00%
0/105 • During the study - 12 weeks.
|
1.0%
1/97 • Number of events 1 • During the study - 12 weeks.
|
|
Infections and infestations
Rhinitis
|
0.95%
1/105 • Number of events 1 • During the study - 12 weeks.
|
0.00%
0/97 • During the study - 12 weeks.
|
|
Infections and infestations
Rhinopharyngitis
|
0.00%
0/105 • During the study - 12 weeks.
|
1.0%
1/97 • Number of events 1 • During the study - 12 weeks.
|
|
Investigations
Increase of leukocytes in the urine
|
0.95%
1/105 • Number of events 1 • During the study - 12 weeks.
|
0.00%
0/97 • During the study - 12 weeks.
|
|
Investigations
Increase of alanine aminotransferase levels
|
0.95%
1/105 • Number of events 1 • During the study - 12 weeks.
|
1.0%
1/97 • Number of events 1 • During the study - 12 weeks.
|
|
Investigations
Increase of aspartate aminotransferase level
|
0.00%
0/105 • During the study - 12 weeks.
|
1.0%
1/97 • Number of events 1 • During the study - 12 weeks.
|
|
Investigations
Increase of glycated hemoglobin level
|
0.00%
0/105 • During the study - 12 weeks.
|
1.0%
1/97 • Number of events 1 • During the study - 12 weeks.
|
|
Investigations
Increase of blood pressure
|
0.95%
1/105 • Number of events 1 • During the study - 12 weeks.
|
3.1%
3/97 • Number of events 3 • During the study - 12 weeks.
|
|
Investigations
Weight loss
|
0.95%
1/105 • Number of events 1 • During the study - 12 weeks.
|
1.0%
1/97 • Number of events 1 • During the study - 12 weeks.
|
|
Metabolism and nutrition disorders
Postprandial hyperglycemia
|
0.00%
0/105 • During the study - 12 weeks.
|
1.0%
1/97 • Number of events 1 • During the study - 12 weeks.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
1.9%
2/105 • Number of events 2 • During the study - 12 weeks.
|
5.2%
5/97 • Number of events 5 • During the study - 12 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.95%
1/105 • Number of events 1 • During the study - 12 weeks.
|
0.00%
0/97 • During the study - 12 weeks.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.95%
1/105 • Number of events 1 • During the study - 12 weeks.
|
0.00%
0/97 • During the study - 12 weeks.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.95%
1/105 • Number of events 1 • During the study - 12 weeks.
|
0.00%
0/97 • During the study - 12 weeks.
|
|
Nervous system disorders
Headache
|
0.95%
1/105 • Number of events 1 • During the study - 12 weeks.
|
2.1%
2/97 • Number of events 2 • During the study - 12 weeks.
|
|
General disorders
Deterioration of the condition
|
0.95%
1/105 • Number of events 1 • During the study - 12 weeks.
|
0.00%
0/97 • During the study - 12 weeks.
|
|
General disorders
Unsteadiness of gait
|
0.95%
1/105 • Number of events 1 • During the study - 12 weeks.
|
0.00%
0/97 • During the study - 12 weeks.
|
|
Injury, poisoning and procedural complications
Concussion of the brain
|
0.00%
0/105 • During the study - 12 weeks.
|
1.0%
1/97 • Number of events 1 • During the study - 12 weeks.
|
|
Injury, poisoning and procedural complications
Soft tissue injury
|
0.00%
0/105 • During the study - 12 weeks.
|
1.0%
1/97 • Number of events 1 • During the study - 12 weeks.
|
Additional Information
Mikhail Putilovskiy, MD, PhD, Clinical and Medical Department Director
MATERIA MEDICA HOLDING
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place